Behavioural change for Parkinson’s Disease: A randomised controlled feasibility study to promote physical activity and exercise adherence among people with Parkinson’s: study protocol

Leanne Ahern; Suzanne Timmons; Sarah E. Lamb; Ruth McCullagh

doi:10.12688/hrbopenres.13843.2

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Study Protocol

Revised

Behavioural change for Parkinson’s Disease: A randomised controlled feasibility study to promote physical activity and exercise adherence among people with Parkinson’s: study protocol

[version 2; peer review: 3 approved]

Leanne Ahern ¹, Suzanne Timmons², Sarah E. Lamb³, Ruth McCullagh¹

PUBLISHED 29 May 2024

Author details Author details

¹ Discipline of Physiotherapy, School of Clinical Therapies, University College Cork, Cork, Ireland
² Centre for Gerontology and Rehabilitation, School of Medicine, College of Medicine and Health, University College Cork, Cork, County Cork, Ireland
³ Faculty of Health and Life Sciences, University of Exeter, Exeter, England, UK

Leanne Ahern
Roles: Conceptualization, Formal Analysis, Methodology, Writing – Original Draft Preparation

Suzanne Timmons
Roles: Conceptualization, Methodology, Supervision, Writing – Review & Editing

Sarah E. Lamb
Roles: Conceptualization, Methodology, Supervision, Writing – Review & Editing

Ruth McCullagh
Roles: Conceptualization, Methodology, Supervision, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the Dementia Trials Ireland (DTI) and Dementia Research Network Ireland (DRNI) gateway.

This article is included in the Ageing Populations collection.

Abstract

Background

Parkinson’s is a common progressive neurological condition characterized by motor and non-motor deficits. Physical activity and exercise can improve health, but many people with Parkinson’s (PwP) have trouble reaching the recommended dosage. Our recent literature review found improvements in exercise adherence with behavioural change interventions, but it remains unclear which are most effective. Further qualitative research and patient and public involvement has informed a novel behavioural change intervention to be tested alongside an existing exercise program.

Objective

To examine the feasibility of behavioural change techniques delivered alongside an exercise programme to improve physical activity, function, and self-efficacy in PwP (and study procedures) to inform a future pilot RCT trial.

Methods

A parallel-arm single blinded randomised feasibility study. Twenty participants with Parkinson’s (Hoehn and Yahr stage 1-3) will be recruited from a physiotherapy primary-care waiting list. Following written consent, and baseline assessment, the participants will be randomly allocated to the intervention (n=10) or the control group (n=10). Both groups will receive usual care, which includes a weekly program of a multidisciplinary education, a supervised exercise class and a prescribed home exercise program. The intervention group will receive additional behavioural change techniques, targeting behaviour regulation, belief about capabilities and social influences. Class and home exercise adherence, behavioural component uptake and adherence, and negative events will be recorded. Outcomes will include enrolment and maintenance rates, physical function, falls, physical activity, and exercise self-efficacy measured pre- and post- the 12-week program (in-person). Surveys will be used to compare experiences and satisfaction between groups. Exit interviews will be completed with the intervention group only, exploring their experience of the behavioural change techniques.

Discussion

The results will help inform a future pilot RCT, based on the intervention acceptability, consent rate, maintenance, and protocol integrity.

Trial Registration

ClincialTrials.gov NCT06192628

Keywords

Parkinson’s Disease, behavioural change intervention, exercise self-efficacy, exercise adherence, physiotherapy, theoretical domains framework.

Corresponding author: Leanne Ahern

Competing interests: No competing interests were disclosed.

Grant information: LA is funded under the Irish Research Council Enterprise Partnership Scheme, in association with the Cork Branch of the Parkinson’s Association of Ireland, schemes@research.ie.
Sarah Lamb is funded by the National Institute of Health Research Exeter Biomedical Research Centre, Applied Research Centre, and National School for Primary Care Research in England.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright: © 2024 Ahern L et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Ahern L, Timmons S, Lamb SE and McCullagh R. Behavioural change for Parkinson’s Disease: A randomised controlled feasibility study to promote physical activity and exercise adherence among people with Parkinson’s: study protocol [version 2; peer review: 3 approved]. HRB Open Res 2024, 7:7 (https://doi.org/10.12688/hrbopenres.13843.2) First published: 16 Feb 2024, 7:7 (https://doi.org/10.12688/hrbopenres.13843.1) Latest published: 29 May 2024, 7:7 (https://doi.org/10.12688/hrbopenres.13843.2)

Revised Amendments from Version 1

Amendments that have been included in the new version are rephrasing and more in-depth descriptions of specific components to improve the readers understandability. For example, firstly, providing more information in our inclusion regarding diagnosis (was is self-reported or confirmed), and falls frequency ( two or more falls in a year). Secondly, the addition of the Borg Rating of Perceived Exertion Scale to monitor exercise intensity. Lastly, more in-depth description of how to conduct the outcome measures (eg TUG).

See the authors' detailed response to the review by Chris Seenan
See the authors' detailed response to the review by Hanna Johansson

Introduction

Parkinson’s is a progressive neurological condition characterized by both motor and non-motor features. Worsening motor features including balance, postural and gait impairments can lead to a sedentary lifestyle, which deteriorates with disease progression¹, contributing to poor quality of life², loss of functional independence² and reduced physical condition². Exercise is important for people with Parkinson’s (PwP) to help control motor and non-motor symptoms³, improving sleep, mood, and memory; it may have a neuroprotective effect, possibly slowing disease progression^4,5. Leisure-time physical activity has been found to reduce motor symptoms, regardless of nigrostriatal degeneration⁶. Despite this growing evidence, as little as 30% of PwP achieve the World Health Organisation recommended activity levels^1,7, some are inactive for 70% of the day, and most are one-third less active than age-matched peers^7,8.

Ellis et al.⁹ has identified self-efficacy and outcome expectations as strong predictors of exercise adherence. However, PwP have reported that one of the primary reasons for poor participation in regular physical activity is lack of motivation¹⁰. Dopamine function, which is associated with motivated behaviour¹¹, is affected in Parkinson’s thus compromising behaviour-reward processing in PwP^12,13. With Parkinson’s progression, there is reduced dopaminergic innervation of the ventral striatum, which is connected to motivational functions¹⁴. This may affect PwPs’ well-being, compliance with and participation in exercise programs and inclination to engage in physical activity¹⁵. It is thus necessary to develop programs that can motivate people to engage in physical activity.

Such programs, promoting engagement and adherence to physical activity and exercise in PwP, are limited, and few studies have investigated interventions consistent with behavioural change. Speelman et al.¹⁶ has shown that behavioural techniques (coaching, goal setting, use of activity monitors) are widely accepted by participants, with 90% reporting benefits from the intervention and 73% reporting they would recommend it to other PwP¹⁶; the activity monitor being identified as the most useful tool¹⁶. The ParkFit trial¹⁷, a 2-year, multi-centred, randomized controlled trial comparing physical therapy emphasising behaviour change (ParkFit program), with matched physical therapy emphasizing safety (ParkSafe program), reported no improvement in physical activity, measured by a self-report questionnaire (their primary outcome measure)¹⁷. However, both the activity diary and the activity monitor data suggested significantly more physical activity in ParkFit participants compared to the ParkSafe group¹⁷. Ellis et al.¹⁸ implemented a single arm clinical study, with a virtual activity coach to promote daily walking. They showed that encouraging walking, monitoring progression, and overcoming barriers with collaborative problem-solving, was well accepted among participants, and led to improvements in adherence to walking, and improved walking speed¹⁸. We recently conducted a systematic review to examine the effects of behavioural change interventions on exercise self-efficacy and adherence in PwP¹⁹. We found that behavioural change methods combined with exercise showed no effect on exercise self-efficacy or adherence but brought small improvements in quality of life and physical function compared to exercise alone¹⁹. Furthermore, by mapping the data to the Theoretical Domains Framework developed by Atkins et al.²⁰ we identified belief about capabilities, goals, behaviour regulation, social influences and reinforcement as the five most effective domains, which healthcare providers should encompass when developing a behavioural change program¹⁹.

Limitations in the available literature includes inadequate sample sizes, with the majority of the studies being non-randomised trials, and limited reporting of the theoretical perspectives, key barriers to implementing the intervention, and rationale for the intervention dose and type of activity^17,18. To date, there is only one definitive multi-centred randomised controlled trial (RCT)¹⁷ investigating the effectiveness of a behavioural change intervention on exercise adherence among PwP, highlighting the need for more large-scale RCTs. Furthermore, this RCT¹⁷ did not assess exercise self-efficacy, which has been identified as a strong predictor of exercise adherence¹⁸. Our recent qualitative research²¹ displayed difference exercise preferences between men and women (such as setting, type, group vs individual) and motivators to exercise, which we will further examine in this study. Clinicians should develop exercise programs targeting individual’s motivators and perceived needs, thus improving long-term participation²¹.

The Parkinson’s Exercise and Education Program (PEEP) is an on-going program run in a Primary Care Centre in Cork city. Informed by existing literature, the program was developed by the first author (LA) in 2021 and modified according to physiotherapy colleagues’ and patients’ reviews. The program is targeted for PwP, at Hoehn and Yahr stage 1-3 (i.e., still physically independent). The program runs for 12 weeks and consists of weekly disease self-management education (45-minutes) an exercise component (45-minutes) and a prescribed home exercise plan.

Research objectives

The aim of this study is to examine the feasibility and acceptability of adding behavioural change techniques to an existing Parkinson’s Exercise and Education Program for people with mild-to-moderate Parkinson’s disease and the study procedures for a future pilot trial. The behavioural change techniques are designed to improve their confidence in managing and progressing their exercise and physical activity independently.

Using mixed methods, the research objectives are:

a) To evaluate the recruitment process and resulting sample characteristics (screen failures, consent refusals).
b) To examine the feasibility of the data collection procedures and outcome measures
c) To explore the acceptability and suitability of the intervention and the study procedures to participants.
d) To assess the time resources required to manage and implement the study and intervention.
e) To explore the trends in outcome measures in terms of range and variability across the entire group.

Methods

This protocol is reported in line with the SPIRIT 2013 Statement: Defining standard protocol items for clinical trials guidelines^22,23 and the intervention description is guided by the Template for Intervention Description and Replication (TIDieR)²⁴. The protocol is reported according to the Consolidated Standards of Reporting Trials (CONSORT) statement extension for randomised pilot and feasibility studies²⁵. [Extended Data: SPIRIT Checklist].

Patient and Public Involvement (PPI)

We held two one-hour meetings with a PPI group (consisting of 4 PwPs; 3 female and 1 male). In one meeting, the findings of our systematic review and qualitative study were presented, and we gained their input on the draft design for the feasibility intervention. In the second meeting, the PPI group read and provided feedback on the participant information sheet and consent form.

Study design

A parallel single-blinded feasibility study comparing an existing Parkinson’s Exercise and Education Program (PEEP, control) and an augmented Parkinson’s Exercise and Education Program with behavioural change supports added (PEEP + BC, intervention). Ethical approval has been granted from the local research ethics committee (CREC registration number: ECM 4 (m) 20/06/2023 & ECM 5 (4) 06/07/2023).

Participants and recruitment

Participants will be recruited from the current waiting list to attend the existing PEEP Program. We plan to recruit 20 participants (10 in each arm) – to optimise numbers while keeping safety paramount in the classes (n=5 per class). We will aim to recruit an equal representation of both sexes (based on self-report). We estimate an attrition rate of 20%, based on previous PEEP programs and available literature^26,27. Prior to random concealed allocation, a member of the research team (LA) will screen participants for eligibility, as follows:

Diagnosis of idiopathic Parkinson’s Disease, confirmed by neurologist or geriatrician.
Early Stages of Parkinson’s, as determined by Hoehn & Yahr Stage 1–3 using the United Parkinson’s Disease Rating Scale).
Ability to drive or obtain transport that will drop and collect at the health centre.
Ability to independently walk (with or without a walking aid).
Reported by the referring healthcare provider or carer as able to follow instructions and carry out the exercise program independently at home.

Participants will be excluded if they have:

A diagnosis of atypical Parkinson’s (e.g., progressive supranuclear palsy, multiple system atrophy, etc) or vascular Parkinsonism or drug-induced parkinsonism
Previously completed the PEEP program.
Had a hospital admission < 6 weeks ago.
Immobility, or are a wheelchair-user.
Severe visual or auditory impairment
Serious medical conditions in major organs (heart, lung, or kidney) or other illnesses which prevent independent ambulation or safe exercise.
Been identified as a high falls risk (identified during the pre-screening using objective measure the Short Physical Performance Battery (a score of ≤6 indicates a higher fall risk in old adults²⁸) and subjective reporting of two or more falls in the past year.

All participants must provide GP clearance letters deeming them medically safe to partake in the exercise component prior to enrolling in the study. Written consent will be obtained from the participants (by LA) before data collection. Participants will be informed that they may withdraw from the study at any time for any reason.

Randomisation

Following written consent and baseline assessment (to ensure blinded assessment), a research staff member (RMcC), not involved in the screening or data collection, will randomly assign eligible participants in a 1:1 ratio, stratified by sex, using a computer-generated randomisation sequence and concealed allocation (sealed envelopes), to the PEEP or the PEEP + BC group. Outcome assessors will be blinded to group allocation. Study participants will be instructed not to share any information on group allocation with the assessor or with other PwP outside the intervention. Every attempt will be made to ensure the assessor is not unblinded; if this occurs, a substitute assessor will be used. The assessor will not be in the facility while the program is being delivered. A full CONSORT²⁵ flow diagram is presented in Figure 1 and will be populated throughout the study. The participant timeline is documented in Table 1.

Figure 1. Consort Flow Diagram detailing the participants planned pathway through the trial²⁵.

Table 1. Participant Timeline.

	Enrolment		Allocation	Post Allocation
Timepoint	-T₂ _{(two weeks before} _baseline)	-T₁ _{(Week before} _baseline)	0	T₀ _(baseline)	T_{1 (post-intervention} _{– Week 12)}
Enrolment:
Eligibility Screen	X
Informed Consent	X
StepWatch Activity Monitor distributed to patients		X
Baseline Assessment		X
Group Allocation			X
Intervention:
PEEP + BC
PEEP
Primary Outcome measures:
Walking Activity (SAM)				X	X
Gait and Balance (APDM Mobility Lab system™)				X	X
Exercise self-efficacy (ESES)				X	X
Secondary Outcome measures:
Physical Endurance (6MWT)				X	X
Quality of Life (PDQ-39)				X	X
Exit Interviews					X
Safety					X

SAM: StepWatch Activity Monitor; ESES: Exercise self-efficacy scale; 6MWT: 6-minute walk test; PDQ-39: Parkinson’s Disease Questionnare-39 Safety: Falls, hospitalisation, muscle soreness

Usual care and intervention details

Materials include gym and exercise equipment [chairs, steps, resistance bands, ankle weights, water bottles (will be used as hand weights)], an Exercise Diary [Extended Data: Appendix A] and a Behavioural Change Template [Extended Data: Appendix B]. One registered physiotherapist (LA) with a special interest in Parkinson’s Disease will be leading the programme, as part of their doctorate training. A physiotherapy assistant, with additional training as a Postural Stability Instructor will be present at all the exercise sessions to ensure safe, correct exercise completion, which will allow the physiotherapist to focus on the behavioural change techniques.

Usual Care: Parkinson’s Exercise and Education Program (PEEP). The usual care consists of three components:

(1) Weekly group exercise class. Classes will be delivered in a primary care physiotherapy gym. They will last approximately 45 minutes, including a five-minute warm-up and cool-down. The exercises class will include eight different exercises (focusing on strength, dynamic balance, coordination, flexibility, and dual tasking). The exercise type will remain consistent throughout the 12 weeks (to aid memory retention), however the progression of exercises will be tailored to each participant’s capability, weekly, by increasing the number of repetitions and step height, heavier resistance bands, addition of hand and ankle weights and adding a cognitive element while performing the exercises. Thus, adjustments in intensity or complexity will be tailored to the individual and progressed with time. Participants will be asked to attend for one hour, to allow 15 minutes for people to settle in, and give an opportunity to socially engage before the exercise class begins. During this time, the physiotherapist (LA) will have a brief 1:1 conversation with each participant about adverse events that may have occurred that week (see section Safety).

(2) Twelve weekly 45-minute group education sessions will be delivered by a range of healthcare professionals and guest speakers including a physiotherapist, speech and language therapist, an occupational therapist, dietician, geriatrician, Parkinson’s specialist nurse, psychologist, social prescriber, and social worker.

These sessions will be delivered in a conference room located next to the Physiotherapy gym in the primary care centre and will include general information to signpost people to services, the role of the healthcare profession in question. Education is provided on medication, symptoms, diet, and aids, but information that could improve exercise self-efficacy and self-management of exercise programs (such as rest, pacing, goal setting etc) is not provided. Following each education session, a hardcopy of the lecture presentation will be provided, and any pamphlets and leaflets recommended by the speaker. The education sessions will be delivered to both groups together, on the day of the usual care group’s exercise classes (the intervention group will have their exercise class on a separate day). All efforts will be made to keep contamination to a minimum as the participants will sit with their own group and will be asked not to discuss the exercise classes with others, and staff will be monitoring conversations in the room. Family-members will also be encouraged to attend the education sessions.

(3) At home, the participants will be expected to independently complete the exercises twice weekly, and this will be discussed at each exercise class with the registered physiotherapist.

Intervention: Parkinson’s Exercise and Education Program with the Behavioural Change Techniques (PEEP + BC). The BC intervention will consist of usual care and four additional techniques to address behavioural regulation, belief about capabilities and peer support.

(1) During the weekly exercise class, the intended functional benefit of the exercises will be explained to everyone. Support will be given to self-select personal exercise intensity and to manage their own exercise and progressions at home. Peer support, competition, reward, and fun will be strongly encouraged and supported by the registered physiotherapist and physiotherapy assistant. By week six, the participants will be invited to lead the class, with the class leader rotating each week, aiming to be independently managing the class by week 12.

(2) An exercise diary to be completed independently at home daily [Extended Data: Appendix A]. Details will include the type of exercise or physical activity of choice, and its duration and intensity (using Borg Rating of Perceived Exertion Scale). Furthermore, they will be asked to reflect on the exercise; their confidence/skill completing the activity, consequences of the activity (both positive and negative) and reasons for non-completion. Daily diary completion will take less than 5 minutes.

(3) Individual one-to-one weekly conversations between the registered physiotherapist and the participant, covering the domains of behavioural regulation, peer support and belief about capabilities. The conversations will be held before each weekly exercise class, when the participants are coming into the gym, while others are settling into the room. All topics will be covered frequently but not weekly, to avoid repetition [Extended Data: Appendix B]. The conversation will last two to five minutes per person (approximately 15 minutes in total per class). During this time, the participant’s exercise diary will be reviewed with the physiotherapist to support the participant to explicitly reflect on progress and their expectations, to identify solutions to any barriers, and to set activity goals for the following week.

(4) Peer support will be further supported with the suggestion of a WhatsApp group. To encourage self-management and to limit the influence of sharing their personal information, the physiotherapist will suggest this at the first visit, when, if possible, a participant will volunteer to lead the WhatsApp group. From this point onwards, the physiotherapist will remain uninvolved but will ask about the use of group chat in the individual conversation.

All participants will be asked to continue their usual exercise during the study period.

Outcomes measures

Feasibility outcomes. Feasibility outcomes of interest include methodological, procedural and clinical uncertainites^25,29,30, examination of recruitment rates, consequences of eligibility criteria, attrition once recruited, data collection completion, resources needed to complete the intervention and the data collection, participant adherence to the intervention, and acceptability of the intervention and study procedures to participants. Feasibility outcomes are shown in Table 2³¹.

Table 2. Overview of feasibility outcomes³¹.

Outcome	Evaluation
Recruitment and eligibility	- Number of patients on current waitlist - Percentage assessed for eligibility; fulfilling inclusion criteria, and included (of total number identified) - Ambiguities regarding eligibility criteria - Reasons for ineligibility - Reasons for non-participation
Data Collection	- Percentage of completed assessments. - Ease of completion and number of missing items - Types and number of potential clinical uncertainties in interviews
Attrition	- Rate of study dropout - Rate of intervention dropout
Resources needed to complete the study and intervention	- Length of time required for: - Participants to work through intervention. - Participants to complete questionnaires and interviews - Study personnel to administer the study
Adherence to the intervention	Number of: - Completed activity diaries. - Exercise classes attended. - Education sessions attended.
Acceptability and experience of the intervention and data collection and exploration of mechanisms of impact	- Reasons for poor attendance and withdrawal from the study and intervention - experience and perception of the behavioural change intervention (including positive and negative consequences) - perceived value of completing home exercise diaries - perceived value of WhatsApp group - perceived value of one-to-one conversations at each exercise class - perceived confidence in self- management - Number and severity of negative events

Process outcomes. The following will be collected to indicate the study process feasibility:

1. Fidelity of delivery of exercise-only and exercise-behaviour change classes (duration; range of exercises included progressing intensity as per plan, etc)
2. Class attendance; drop-out rates; set-up administrative time required (participant queries between classes, room preparation, etc)
3. Completion of home-based (self-reported) exercise activity (exercise type, number of repetitions, intensity)
4. Fidelity and barriers of delivery of the behaviour change intervention (review of the records of one-to-one discussions [Extended Data: Appendix B] and researcher completion of a reflective log after each exercise session.

Acceptability. The acceptability of the class and independent exercise (both groups) will be explored by surveys [Extended Data: Appendix C], and the behavioural component will be explored through additional exit interviews, using a semi-structured interview, with the intervention group only [Extended Data: Appendix D].

Safety. Falls (number and frequency), injuries (cuts, bruises, muscle pains, other injuries), ED attendance or hospitalisation, and death will be considered as adverse events and will be discussed and recorded during the weekly conversations held before each exercise class. If a participant does not attend (without prior explanation) they will be contacted. Family members will be contacted if the participant does not answer over one week, for those who do not have family, the GP will be contacted. Any serious adverse events will be reported to the Chief Medical Officer of UCC.

Performance outcomes. For performance outcomes see Table 1. We will complete all mobility-related assessments during the participants’ ON phase for consistency (i.e., 1–2 hours post medications, and stated “good time of day”)

Walking activity and falls events. The Stepwatch Activity Monitor will be used to measure step-count and physical activity. This is a validated accelerometer, with excellent accuracy in PwP³². The device is ankle-worn and is fully waterproof, allowing seven days of uninterrupted data collection. Participants will be asked to wear the accelerometer for the week before the programme begin, and again, for the final week of the programme. Within-person differences in average daily step count will be used to examine changes in physical activity. As it is well known that activity diaries are unreliable measures of activity³³, we will focus on accelerometery data only as a measure of physical/walking activity.

Falls and ‘near falls’ are the only measures that will be taken from the Activity Log. These events will be discussed in both groups during weekly one-to-one discussions about adverse event with all participants (at the beginning of the exercise class) and recorded.

Gait and balance. Physical performance will be measured objectively before and immediately after the program using the APDM Mobility Lab system™ (http://www.apdm.com/mobility/). The APDM Lab system uses coordinated, wearable inertial sensors to precisely analyse quality of gait and balance³⁴. It is a portable gait and balance laboratory and allows streamlined gait and balance assessment by making it easy to collect, store, analyse, and interpret balance and gait data from a large set of prescribed tasks³⁴. It is a validated device to objectively measure walking and balance in PwP³⁴. Five Opals™ (accelerometers) will be attached to participants two feet (ankles) and two arms (wrists) and one at the waist using Velcro straps (provided). The participants will be asked to stand, walk a 3-metre distance, turn around, walk back to the chair, and sit down (Timed Up and Go Test (TUG)). A 2-minute free walk (at the participants self-selected pace) will be recorded also to examine stride length and turns specifically.

Exercise self-efficacy. Exercise self-efficacy will be measured using the Exercise Self-Efficacy Scale³⁵ (ESES) at baseline, immediately post-intervention. The ESES is a self-report instrument, validated in PwP³⁴, containing ten statements about how confident the person is performing physical activity and exercise³⁶. Responses are chosen from a four-point scale with 1 = not at all true to 4 = always true (score range 10–40, higher indicating more confidence³⁶.)

Secondary outcome measures. We defined two secondary measures:

Physical endurance

Physical endurance will be measured with the six-minute walk test³⁵ (6MWT) at baseline and post-intervention. Participants walk continuously for six minutes at their self-selected pace. As recommended, an indoor hallway with the 10m distance will be used, and total distance will be recorded.

Quality of life (QoL)

QoL will be measured using the Parkinson’s Disease Questionnaire³⁷ (PDQ-39) at baseline, and post-intervention. The PDQ-39 assesses Parkinson’s disease-specific health-related QoL in the previous month across eight dimensions of daily living³⁷, with specific dimensions of functioning and wellbeing³⁷.

Data collection

Baseline data will include personal information such as demographics (including age and self-reported sex), social history, medical history, disease severity (using the United Parkinson’s Disease Rating Scale – motor exam) and medication history will be collected before randomisation by the research physiotherapist (LA) and the Stepwatch Activity Monitor will be programmed and, as per the manufacturer’s instructions, attached to the participants ankle at the end of the assessment. They will be instructed to wear the accelerometer continuously for seven days, until they return the following week, when the device is removed the data will be downloaded onto a password protected file on the research laptop. Participants will be encouraged to contact the research physiotherapist with any concerns about the accelerometer during the week, and a courtesy call will be made during the week to ensure data collection.

Similarly, the participants will be asked to wear the accelerometer for the final week of the program. On the last day of the program, the accelerometer will be removed, and the data will be downloaded. The outcome assessments will be completed by a blinded registered physiotherapist, who is fully trained in the completion of the assessments.

Adherence. Full adherence to the intervention will be defined as follows: 1) attending the baseline and immediate post-intervention assessments, 2) completing 12 weekly activity diaries and 3) attending all 12 exercises classes, attending all 12 education sessions. Attendance at the exercise classes and education sessions will be documented each week by the registered physiotherapist. Activity diaries will be viewed each week during the weekly one to one weekly conversations between the registered physiotherapist and the participant before each exercise class.

Qualitative process evaluation. All participants will be asked to complete a feedback survey [Extended Data: Appendix C] with open-ended questions exploring what they liked/disliked about the PEEP program, elements of the program they felt were not required, or elements they believe should have been included in the program, and their opinions of the topics covered during the education sessions. On-line semi-structured interviews exploring the acceptability of the behavioural change techniques will be conducted a research physiotherapist (RMcC) with the intervention participants only, immediately post-intervention (12 weeks). Participants will be asked to discuss the perceived impact and value, and how the intervention address barriers to exercise and physical activity. The interview guide will be informed by previous research examining the acceptability of BC interventions^38–40 coded under the domains of the Theoretical Domains Framework²⁰. [Extended Data: Appendix D]

Data analysis

Quantitative analysis. With small numbers in each group, we will present and treat all continuous data as non-parametric data. Suitable summary statistics (e.g., median, interquartile range, and frequency, percentages) will be provided for all outcomes.

These summary statistics will be used to assess the feasibility of the intervention. Potential ambiguities regarding standard safety procedures, types and numbers of measures undertaken to assure patient safety, and types and numbers of unforeseen safety issues will be reported and disaggregated by sex. We will analyse the results according to a modified intention-to-treat principle, whereby we will exclude only patients with no follow-up measurements at all.

Qualitative analysis. Data from the semi-structured interview questions will be audio- recorded, transcribed verbatim, and analysed with the data from the surveys using qualitative content analysis. Difference between the sexes will be carefully considered.

Dissemination of data

A paper describing the main outcomes of the feasibility study, including the qualitative data, will be submitted to a peer review journals and the results will be presented both locally to physiotherapy clinical colleagues, and at international conferences and will be presented to the Cork Branch of the Parkinson’s Association of Ireland. A poster summarising the results in simple terms will be produced and placed on the wall of the Primary care centre.

Amendments

The publication of the study’s result will include any amendments to this protocol in tabular format including the date, description, and rationale of each amendment (section “Differences between protocol and study”). The clinicaltrials.gov register will remain updated with the protocol and any amendments made.

Ethical application

Full ethical approval has been granted for the study by Clinical Research Ethics Committee of the Cork Teaching Hospitals (Registration number: ECM 4 (m) 20/06/2023 & ECM 5 (4) 06/07/2023).

Study status

The feasibility study is due to commence participant recruitment in November 2023.

Discussion

This intervention has been informed from our previous systematic review¹⁹ and qualitative studies²¹ with participants and healthcare providers. These studies showed us that people want to exercise but are frustrated by the barriers and reliance on healthcare providers or family to manage or motivate them to exercise. We propose to examine the feasibility of a behaviour change intervention to address behaviour regulation, belief about capabilities and peer support by encouraging self-progression, reflection, competition, fun and reward to drive adherence and self-management of exercise behaviours.

The results of this feasibility study will inform a future pilot trial, by examining responsiveness of outcome measures, consent rate, and qualitatively exploring acceptability and experiences of the intervention which will help to refine the intervention and may explain uptake and adherence rates. We will consider sex differences, if any that emerge from the qualitative interviews.

The effects of behavioural change intervention on exercise adherence and exercise self-efficacy remains unclear. There is a clear need for participatory research to design interventions that help PwP to maintain health and wellbeing. While not definitive, this study will help further behavioural change intervention design informed by the published literature, stakeholder input and PPI involvement.

Data availability

Underlying data

No data are associated with this article.

Extended data

Dryad: Extended Data for Behavioural change for Parkinson’s Disease: A randomised controlled feasibility study to promote physical activity and exercise adherence among people with Parkinson’s: study protocol, https://doi.org/10.5061/dryad.prr4xgxt5⁴¹.

Reporting guidelines

Zenodo: SPIRIT checklist for ‘Behavioural change for Parkinson’s Disease: A randomised controlled feasibility study to promote physical activity and exercise adherence among people with Parkinson’s: study protocol’, https://doi.org/10.5281/zenodo.10407626⁴².

Faculty Opinions recommended

References

1. van Nimwegen M, Speelman AD, Hofman-van Rossum EJ, et al.: Physical inactivity in Parkinson's disease. J Neurol. 2011; 258(12): 2214–21. PubMed Abstract | Publisher Full Text | Free Full Text
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Version 2

VERSION 2 PUBLISHED 16 Feb 2024

Author details Author details

Leanne Ahern
Roles: Conceptualization, Formal Analysis, Methodology, Writing – Original Draft Preparation

Suzanne Timmons
Roles: Conceptualization, Methodology, Supervision, Writing – Review & Editing

Sarah E. Lamb
Roles: Conceptualization, Methodology, Supervision, Writing – Review & Editing

Ruth McCullagh
Roles: Conceptualization, Methodology, Supervision, Writing – Review & Editing

Competing interests

No competing interests were disclosed.

Grant information

LA is funded under the Irish Research Council Enterprise Partnership Scheme, in association with the Cork Branch of the Parkinson’s Association of Ireland, schemes@research.ie.
Sarah Lamb is funded by the National Institute of Health Research Exeter Biomedical Research Centre, Applied Research Centre, and National School for Primary Care Research in England.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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https://doi.org/10.12688/hrbopenres.13843.2

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© 2024 Ahern L et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Ahern L, Timmons S, Lamb SE and McCullagh R. Behavioural change for Parkinson’s Disease: A randomised controlled feasibility study to promote physical activity and exercise adherence among people with Parkinson’s: study protocol [version 2; peer review: 3 approved]. HRB Open Res 2024, 7:7 (https://doi.org/10.12688/hrbopenres.13843.2)

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Reviewer Report 18 Dec 2024

Mark Manago, University of Colorado Denver Anschutz Medical Campus, Aurora, Colorado, USA

Approved

https://doi.org/10.21956/hrbopenres.15253.r44011

This is an interesting study protocol designed to increase exercise adherence in PwP. It is overall well-designed to test the primary feasibility aims. The study is well-justified in context of the current literature and preliminary work. I commend the authors for beginning this line of work with a mixed-methods feasibility design and clearly defined feasibility criteria. The active ingredients of the BC intervention are well-justified and clearly described. The report is overall easy to follow and clearly written. However, there are several minor typos that could be addressed by a careful read through.

Abstract
In the Objective statement, it is unclear what is meant by “(and study procedure)”. That is, why is this enclosed in parentheses?

Methods
What is the justification of having equal representation of sexes when PD typically affects more men? Especially when the PPI group was not equally divided by sex (3F 1M).

Why will the researchers collect an instrumented 2-minute free walk and then separately collect a 6-minute walk test? It seems unnecessary and fatiguing to do both. Why not instrument the 6MWT or just make the 2-minute walk the test of walking endurance?

Data Analysis
I am not sure limiting your analysis to non-parametric statistics is the best option, especially before reviewing distributions. You will potentially get more meaningful/useful data from understanding the variability of the data through standard deviations/ confidence intervals, especially for key outcomes that you might considering powering the next phase on. Maybe consider tempering this language to say something about how you will consider the data distribution during analysis.

Dissemination
Could you also include dissemination to patient groups both regionally and nationally?

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Rehabilitation research in people with MS and PD

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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Reviewer Report 14 May 2024

Chris Seenan, Glasgow Caledonian University, Glasgow, Scotland, UK

Approved

https://doi.org/10.21956/hrbopenres.15168.r38320

The article details a protocol for a randomized feasibility trial comparing standard care to additional behavior change intervention in people with Parkinson's disease. Feasibility and acceptability of the novel approach will be explored recruiting participants from an existing exercise and education class.
The objectives and planned outcomes from the study are well matched and described. The protocol is presented according to appropriate reporting guidelines and the additional material provides adequate information that would enable replication.
Overall, this is a well-presented protocol describing a useful and well-designed study in an important area of practice. The findings of the study will enable progression within the field and for people with Parkinson's disease.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Yes

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: My expertise is within cardiovascular disease, physiotherapy and developing behaviour change interventions for long term conditions. I have experience designing and implementing feasibility trials in clinical practice.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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Author Response 11 Jun 2024

Leanne Ahern, Discipline of Physiotherapy, School of Clinical Therapies, University College Cork, Cork, Ireland

11 Jun 2024

Author Response

Thank you very much for taking the time to review the study protocol. We greatly appreciate your feedback
Competing Interests: Nil
Thank you very much for taking the time to review the study protocol. We greatly appreciate your feedback
Thank you very much for taking the time to review the study protocol. We greatly appreciate your feedback
Competing Interests: Nil Close
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COMMENTS ON THIS REPORT

Author Response 11 Jun 2024

Leanne Ahern, Discipline of Physiotherapy, School of Clinical Therapies, University College Cork, Cork, Ireland

11 Jun 2024

Author Response

Thank you very much for taking the time to review the study protocol. We greatly appreciate your feedback
Competing Interests: Nil
Thank you very much for taking the time to review the study protocol. We greatly appreciate your feedback
Thank you very much for taking the time to review the study protocol. We greatly appreciate your feedback
Competing Interests: Nil Close
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Reviewer Report 08 May 2024

Hanna Johansson, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden

Approved

https://doi.org/10.21956/hrbopenres.15168.r38949

The authors here describe a study protocol for a parallel-arm single blinded randomised feasibility study involving people with mild-to-moderate Parkinson’s disease. Both groups will receive multidisciplinary education, a supervised exercise class and a home exercise program, but additional behavioural change techniques will be added to the intervention group. Exercise studies, and especially those involving elements of behavioural change, are highly needed in the Parkinson’s research. Evaluating the feasibility of a study design before commencing with a larger scale RCT is of utmost importance, and I commend the authors for doing this valuable ground-work.

Below are some questions and suggestions for the authors to consider and address as they find appropriate.

Feasibility/methodology

Consider formulating progression criteria to better help you assess whether and how to progress to a full-scale RCT (see Mellor K, et.al.,2023 [Ref 1] for recommendations.)
Considering that the authors plan to perform a RCT on a smaller scale, and to assess most elements of this process, I would say that this is in fact a pilot RCT. How come the authors do not intend to use the results of this study to inform a larger scale RCT, instead of planning to perform yet another pilot study?
Please consider evaluating the randomization process as well as the ability to maintain blinding throughout the study.
Will the results of this study help inform the choice of a primary outcome for the planned RCT? If so, please describe how.

Participants/recruitment/screening

How will a diagnosis of idiopathic PD be confirmed?
How will Hoehn and Yahr stage be confirmed? Using the MDS-UPDRS III?
Fall risk and fall history will be assessed during pre-screening. Please describe the cut-off used to define “frequent falls”.
Have the authors considered excluding participants who are already highly physically active in their daily life? It is a common problem in exercise studies that people who are already active tend to sign up, thereby resulting in biased samples and lowered ability to show effect. If physically active people are recruited, please make sure participants are willing to continue with their usual exercise during the intervention period.

Outcomes/assessments

Have the authors considered evaluating cognitive function?
Have the authors considered evaluating symptoms of depression or anxiety since this can negatively affect exercise adherence/motivation etc?
Why not use accelerometers the week after the intervention has ended, instead of letting participants wear them the last week of the intervention?
Perhaps just a typo, but I can only see two secondary outcome measures (6-min walk test and PDQ-39) even though the authors state that there should be four.
What is the rationale for performing both the 2-minute walk test and the 6-minute walk test? Will both tests be performed at self-selected (i.e., usual) pace?
The authors state that the recommendation for the 6-minute walk test is to conduct it in an indoor hallway over a 10-meter distance, but this is not correct. The American Thoracic Society recommends it be performed over 100 ft (apx 30 meter). If possible, I therefore suggest that both the 2- and the 6-minute walk test be performed over a 30 meter distance.
The TUG test is not described correctly (does not describe the first turn and the 3 meter walk back to the chair).
Why use five and not six opals? Please consider adding the sternum opal as well so that you can assess sit-to-stand/stand-to-sit transfers during the TUG.

Intervention

Regarding the home exercise diary, I am curious as to how difficulty level will be explained to participants. Is this based on physical exhaustion or other? If so, have you considered letting participants rate this using for example Borg RPE instead?
The behavioural change template (Appendix B) seems a bit too exhaustive to complete in 2-5minutes. The authors state that not all questions will be addressed each week, but how will you choose which ones to focus on each week?
I think the authors have done a great job of describing both the control group and the intervention group, but I wonder whether it would be good to have a table outlining all elements as well to get a better overview of which elements are overlapping versus those that are group-specific.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

References

1. Mellor K, Albury C, Dutton SJ, Eldridge S, et al.: Recommendations for progression criteria during external randomised pilot trial design, conduct, analysis and reporting.Pilot Feasibility Stud. 2023; 9 (1): 59 PubMed Abstract | Publisher Full Text

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Parkinsons disease

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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Author Response 11 Jun 2024

Leanne Ahern, Discipline of Physiotherapy, School of Clinical Therapies, University College Cork, Cork, Ireland

11 Jun 2024

Author Response
Thank you very much for taking the time to review the study protocol. We appreciate your suggestions, many of which we have added, and we hope that we have addressed ... Continue reading
Thank you very much for taking the time to review the study protocol. We appreciate your suggestions, many of which we have added, and we hope that we have addressed them appropriately. We have detailed the responses below.

Feasibility/methodology

Consider formulating progression criteria to better help you assess whether and how to progress to a full-scale RCT (see Mellor K, et.al.,2023 [Ref 1] for recommendations.)

Response: Thank you for your suggestion – it will be valuable step in our future pilot study.

Considering that the authors plan to perform a RCT on a smaller scale, and to assess most elements of this process, I would say that this is in fact a pilot RCT. How come the authors do not intend to use the results of this study to inform a larger scale RCT, instead of planning to perform yet another pilot study?

Response: Thank you for your query. As a team, we considered this quite extensively, and decided that there were too many unknowns for this to be a pilot study. To tease apart the different components was an important aim of the study, rather than to consider the intervention as one multicomponent intervention. Therefore, we decided to test the intervention as a feasibility study, allowing us to take the intervention apart, as such, and use the qualitative feedback to further inform our decisions.

Please consider evaluating the randomization process as well as the ability to maintain blinding throughout the study.

Response: Thank you for highlighting this. We agree that the methods can lead to bias. Unfortunately, for this study with existing resources, we are unable to change these, but will be considered for future studies, including the planned pilot.

Will the results of this study help inform the choice of a primary outcome for the planned RCT? If so, please describe how.

Response: We anticipate that the intervention may be further refined from this study. We plan to analyse for trends of change, and to examine which measures appear to be more sensitive to change, however, we do not anticipate that we will choose the primary outcome measure from this study. Our current focus is more on feasibility of data collection.

Participants/recruitment/screening

How will a diagnosis of idiopathic PD be confirmed?

Response: Thank you for bringing this to our attention. Idiopathic PD will be confirmed by a consultant neurologist or geriatrician. This is part of the referral process. We have added this in the text, under Participants and recruitment; Page 6, line 6.

How will Hoehn and Yahr stage be confirmed? Using the MDS-UPDRS III?

Response: Yes, that is correct – we have added this detail. - Page 6, line 7.

Fall risk and fall history will be assessed during pre-screening. Please describe the cut-off used to define “frequent falls”.

Response: We defined frequent falls as two or more falls in the last year, based on Goodwin et al.¹ and have added this to the exclusion criteria in the text - Page 6, line 23.

Have the authors considered excluding participants who are already highly physically active in their daily life? It is a common problem in exercise studies that people who are already active tend to sign up, thereby resulting in biased samples and lowered ability to show effect. If physically active people are recruited, please make sure participants are willing to continue with their usual exercise during the intervention period.

Response: Thank you for your suggestion. The main aim of this study was to test the feasibility of the data collection and the programme delivery. We are limited by time and resources. We will use this as an for the future RCT. We have added in the text that we will ask all participants to continue with their usual exercise during the intervention period – page 10, line 24

Outcomes/assessments

Have the authors considered evaluating cognitive function?

Response: We have not considered it for this feasibility study, but this will be considered for the future pilot study and RCT

Have the authors considered evaluating symptoms of depression or anxiety since this can negatively affect exercise adherence/motivation etc?

Response: Again, we have not considered it for this pilot, but going forward, we can see its value in future studies.

Why not use accelerometers the week after the intervention has ended, instead of letting participants wear them the last week of the intervention?

Response: We selected the last week of the intervention as we would be able to collect them easily from the participants at the last session, rather than ask them to return / send the accelerometers back to us. For earlier studies, we have experience of them being misplaced or lost. Many forget they are wearing them.

Perhaps just a typo, but I can only see two secondary outcome measures (6-min walk test and PDQ-39) even though the authors state that there should be four.

Response: Thank you for bringing this to our attention. We have corrected this, page 10, line 18.

What is the rationale for performing both the 2-minute walk test and the 6-minute walk test? Will both tests be performed at self-selected (i.e., usual) pace?

Response: We will perform the 2-minute walk test using the APDM data collection. The 6MWT will be performed separately to measure physical endurance. Yes, both are performed at self-selected pace. The report has been reworded to clarify this.

The authors state that the recommendation for the 6-minute walk test is to conduct it in an indoor hallway over a 10-meter distance, but this is not correct. The American Thoracic Society recommends it be performed over 100 ft (apx 30 meter). If possible, I therefore suggest that both the 2- and the 6-minute walk test be performed over a 30 meter distance.

Response: Thank you for this important information. We have begun data collection and are now delivering the programme. This will be recognised as a limitation of the study in the final report. In future studies, we will use a 30 m walkway, but will continue to use the 10m walkway to standardize among participants.

The TUG test is not described correctly (does not describe the first turn and the 3 meter walk back to the chair).

Response: Thank you for bringing this to our attention. We have corrected this, page 10, line 7

Why use five and not six opals? Please consider adding the sternum opal as well so that you can assess sit-to-stand/stand-to-sit transfers during the TUG.

Response: Thank you for your suggestion. We aim to keep the data collection as simple as possible. We decided this protocol based on the advice we received from colleagues in KU Leuven, who advised to collect the data using 5 opals.  Based on our results, we may add the additional sixth opal for future studies.

Intervention

Regarding the home exercise diary, I am curious as to how difficulty level will be explained to participants. Is this based on physical exhaustion or other? If so, have you considered letting participants rate this using for example Borg RPE instead?

Response: Thank you for your suggestion, we can see the value of this and have added it to the protocol, Page 10, line 5

The behavioural change template (Appendix B) seems a bit too exhaustive to complete in 2-5minutes. The authors state that not all questions will be addressed each week, but how will you choose which ones to focus on each week?

Response: Thank you for your suggestion. We had planned on using sections of the template each week; not to use the complete template every week. We have divided this into weekly templates and have added these to the repository.

References
1.           Goodwin VA, Richards SH, Henley W, Ewings P, Taylor AH, Campbell JL. An exercise intervention to prevent falls in people with Parkinson's disease: a pragmatic randomised controlled trial. Journal of Neurology, Neurosurgery & Psychiatry. 2011;82(11):1232-1238.
Thank you very much for taking the time to review the study protocol. We appreciate your suggestions, many of which we have added, and we hope that we have addressed them appropriately. We have detailed the responses below.

Feasibility/methodology

Consider formulating progression criteria to better help you assess whether and how to progress to a full-scale RCT (see Mellor K, et.al.,2023 [Ref 1] for recommendations.)

Response: Thank you for your suggestion – it will be valuable step in our future pilot study.

Considering that the authors plan to perform a RCT on a smaller scale, and to assess most elements of this process, I would say that this is in fact a pilot RCT. How come the authors do not intend to use the results of this study to inform a larger scale RCT, instead of planning to perform yet another pilot study?

Response: Thank you for your query. As a team, we considered this quite extensively, and decided that there were too many unknowns for this to be a pilot study. To tease apart the different components was an important aim of the study, rather than to consider the intervention as one multicomponent intervention. Therefore, we decided to test the intervention as a feasibility study, allowing us to take the intervention apart, as such, and use the qualitative feedback to further inform our decisions.

Please consider evaluating the randomization process as well as the ability to maintain blinding throughout the study.

Response: Thank you for highlighting this. We agree that the methods can lead to bias. Unfortunately, for this study with existing resources, we are unable to change these, but will be considered for future studies, including the planned pilot.

Will the results of this study help inform the choice of a primary outcome for the planned RCT? If so, please describe how.

Response: We anticipate that the intervention may be further refined from this study. We plan to analyse for trends of change, and to examine which measures appear to be more sensitive to change, however, we do not anticipate that we will choose the primary outcome measure from this study. Our current focus is more on feasibility of data collection.

Participants/recruitment/screening

How will a diagnosis of idiopathic PD be confirmed?

Response: Thank you for bringing this to our attention. Idiopathic PD will be confirmed by a consultant neurologist or geriatrician. This is part of the referral process. We have added this in the text, under Participants and recruitment; Page 6, line 6.

How will Hoehn and Yahr stage be confirmed? Using the MDS-UPDRS III?

Response: Yes, that is correct – we have added this detail. - Page 6, line 7.

Fall risk and fall history will be assessed during pre-screening. Please describe the cut-off used to define “frequent falls”.

Response: We defined frequent falls as two or more falls in the last year, based on Goodwin et al.¹ and have added this to the exclusion criteria in the text - Page 6, line 23.

Have the authors considered excluding participants who are already highly physically active in their daily life? It is a common problem in exercise studies that people who are already active tend to sign up, thereby resulting in biased samples and lowered ability to show effect. If physically active people are recruited, please make sure participants are willing to continue with their usual exercise during the intervention period.

Response: Thank you for your suggestion. The main aim of this study was to test the feasibility of the data collection and the programme delivery. We are limited by time and resources. We will use this as an for the future RCT. We have added in the text that we will ask all participants to continue with their usual exercise during the intervention period – page 10, line 24

Outcomes/assessments

Have the authors considered evaluating cognitive function?

Response: We have not considered it for this feasibility study, but this will be considered for the future pilot study and RCT

Have the authors considered evaluating symptoms of depression or anxiety since this can negatively affect exercise adherence/motivation etc?

Response: Again, we have not considered it for this pilot, but going forward, we can see its value in future studies.

Why not use accelerometers the week after the intervention has ended, instead of letting participants wear them the last week of the intervention?

Response: We selected the last week of the intervention as we would be able to collect them easily from the participants at the last session, rather than ask them to return / send the accelerometers back to us. For earlier studies, we have experience of them being misplaced or lost. Many forget they are wearing them.

Perhaps just a typo, but I can only see two secondary outcome measures (6-min walk test and PDQ-39) even though the authors state that there should be four.

Response: Thank you for bringing this to our attention. We have corrected this, page 10, line 18.

What is the rationale for performing both the 2-minute walk test and the 6-minute walk test? Will both tests be performed at self-selected (i.e., usual) pace?

Response: We will perform the 2-minute walk test using the APDM data collection. The 6MWT will be performed separately to measure physical endurance. Yes, both are performed at self-selected pace. The report has been reworded to clarify this.

The authors state that the recommendation for the 6-minute walk test is to conduct it in an indoor hallway over a 10-meter distance, but this is not correct. The American Thoracic Society recommends it be performed over 100 ft (apx 30 meter). If possible, I therefore suggest that both the 2- and the 6-minute walk test be performed over a 30 meter distance.

Response: Thank you for this important information. We have begun data collection and are now delivering the programme. This will be recognised as a limitation of the study in the final report. In future studies, we will use a 30 m walkway, but will continue to use the 10m walkway to standardize among participants.

The TUG test is not described correctly (does not describe the first turn and the 3 meter walk back to the chair).

Response: Thank you for bringing this to our attention. We have corrected this, page 10, line 7

Why use five and not six opals? Please consider adding the sternum opal as well so that you can assess sit-to-stand/stand-to-sit transfers during the TUG.

Response: Thank you for your suggestion. We aim to keep the data collection as simple as possible. We decided this protocol based on the advice we received from colleagues in KU Leuven, who advised to collect the data using 5 opals.  Based on our results, we may add the additional sixth opal for future studies.

Intervention

Regarding the home exercise diary, I am curious as to how difficulty level will be explained to participants. Is this based on physical exhaustion or other? If so, have you considered letting participants rate this using for example Borg RPE instead?

Response: Thank you for your suggestion, we can see the value of this and have added it to the protocol, Page 10, line 5

The behavioural change template (Appendix B) seems a bit too exhaustive to complete in 2-5minutes. The authors state that not all questions will be addressed each week, but how will you choose which ones to focus on each week?

Response: Thank you for your suggestion. We had planned on using sections of the template each week; not to use the complete template every week. We have divided this into weekly templates and have added these to the repository.

References
1.           Goodwin VA, Richards SH, Henley W, Ewings P, Taylor AH, Campbell JL. An exercise intervention to prevent falls in people with Parkinson's disease: a pragmatic randomised controlled trial. Journal of Neurology, Neurosurgery & Psychiatry. 2011;82(11):1232-1238.
Competing Interests: Nil Close
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COMMENTS ON THIS REPORT

Author Response 11 Jun 2024

Leanne Ahern, Discipline of Physiotherapy, School of Clinical Therapies, University College Cork, Cork, Ireland

11 Jun 2024

Author Response
Thank you very much for taking the time to review the study protocol. We appreciate your suggestions, many of which we have added, and we hope that we have addressed ... Continue reading
Thank you very much for taking the time to review the study protocol. We appreciate your suggestions, many of which we have added, and we hope that we have addressed them appropriately. We have detailed the responses below.

Feasibility/methodology

Consider formulating progression criteria to better help you assess whether and how to progress to a full-scale RCT (see Mellor K, et.al.,2023 [Ref 1] for recommendations.)

Response: Thank you for your suggestion – it will be valuable step in our future pilot study.

Considering that the authors plan to perform a RCT on a smaller scale, and to assess most elements of this process, I would say that this is in fact a pilot RCT. How come the authors do not intend to use the results of this study to inform a larger scale RCT, instead of planning to perform yet another pilot study?

Response: Thank you for your query. As a team, we considered this quite extensively, and decided that there were too many unknowns for this to be a pilot study. To tease apart the different components was an important aim of the study, rather than to consider the intervention as one multicomponent intervention. Therefore, we decided to test the intervention as a feasibility study, allowing us to take the intervention apart, as such, and use the qualitative feedback to further inform our decisions.

Please consider evaluating the randomization process as well as the ability to maintain blinding throughout the study.

Response: Thank you for highlighting this. We agree that the methods can lead to bias. Unfortunately, for this study with existing resources, we are unable to change these, but will be considered for future studies, including the planned pilot.

Will the results of this study help inform the choice of a primary outcome for the planned RCT? If so, please describe how.

Response: We anticipate that the intervention may be further refined from this study. We plan to analyse for trends of change, and to examine which measures appear to be more sensitive to change, however, we do not anticipate that we will choose the primary outcome measure from this study. Our current focus is more on feasibility of data collection.

Participants/recruitment/screening

How will a diagnosis of idiopathic PD be confirmed?

Response: Thank you for bringing this to our attention. Idiopathic PD will be confirmed by a consultant neurologist or geriatrician. This is part of the referral process. We have added this in the text, under Participants and recruitment; Page 6, line 6.

How will Hoehn and Yahr stage be confirmed? Using the MDS-UPDRS III?

Response: Yes, that is correct – we have added this detail. - Page 6, line 7.

Fall risk and fall history will be assessed during pre-screening. Please describe the cut-off used to define “frequent falls”.

Response: We defined frequent falls as two or more falls in the last year, based on Goodwin et al.¹ and have added this to the exclusion criteria in the text - Page 6, line 23.

Have the authors considered excluding participants who are already highly physically active in their daily life? It is a common problem in exercise studies that people who are already active tend to sign up, thereby resulting in biased samples and lowered ability to show effect. If physically active people are recruited, please make sure participants are willing to continue with their usual exercise during the intervention period.

Response: Thank you for your suggestion. The main aim of this study was to test the feasibility of the data collection and the programme delivery. We are limited by time and resources. We will use this as an for the future RCT. We have added in the text that we will ask all participants to continue with their usual exercise during the intervention period – page 10, line 24

Outcomes/assessments

Have the authors considered evaluating cognitive function?

Response: We have not considered it for this feasibility study, but this will be considered for the future pilot study and RCT

Have the authors considered evaluating symptoms of depression or anxiety since this can negatively affect exercise adherence/motivation etc?

Response: Again, we have not considered it for this pilot, but going forward, we can see its value in future studies.

Why not use accelerometers the week after the intervention has ended, instead of letting participants wear them the last week of the intervention?

Response: We selected the last week of the intervention as we would be able to collect them easily from the participants at the last session, rather than ask them to return / send the accelerometers back to us. For earlier studies, we have experience of them being misplaced or lost. Many forget they are wearing them.

Perhaps just a typo, but I can only see two secondary outcome measures (6-min walk test and PDQ-39) even though the authors state that there should be four.

Response: Thank you for bringing this to our attention. We have corrected this, page 10, line 18.

What is the rationale for performing both the 2-minute walk test and the 6-minute walk test? Will both tests be performed at self-selected (i.e., usual) pace?

Response: We will perform the 2-minute walk test using the APDM data collection. The 6MWT will be performed separately to measure physical endurance. Yes, both are performed at self-selected pace. The report has been reworded to clarify this.

The authors state that the recommendation for the 6-minute walk test is to conduct it in an indoor hallway over a 10-meter distance, but this is not correct. The American Thoracic Society recommends it be performed over 100 ft (apx 30 meter). If possible, I therefore suggest that both the 2- and the 6-minute walk test be performed over a 30 meter distance.

Response: Thank you for this important information. We have begun data collection and are now delivering the programme. This will be recognised as a limitation of the study in the final report. In future studies, we will use a 30 m walkway, but will continue to use the 10m walkway to standardize among participants.

The TUG test is not described correctly (does not describe the first turn and the 3 meter walk back to the chair).

Response: Thank you for bringing this to our attention. We have corrected this, page 10, line 7

Why use five and not six opals? Please consider adding the sternum opal as well so that you can assess sit-to-stand/stand-to-sit transfers during the TUG.

Response: Thank you for your suggestion. We aim to keep the data collection as simple as possible. We decided this protocol based on the advice we received from colleagues in KU Leuven, who advised to collect the data using 5 opals.  Based on our results, we may add the additional sixth opal for future studies.

Intervention

Regarding the home exercise diary, I am curious as to how difficulty level will be explained to participants. Is this based on physical exhaustion or other? If so, have you considered letting participants rate this using for example Borg RPE instead?

Response: Thank you for your suggestion, we can see the value of this and have added it to the protocol, Page 10, line 5

The behavioural change template (Appendix B) seems a bit too exhaustive to complete in 2-5minutes. The authors state that not all questions will be addressed each week, but how will you choose which ones to focus on each week?

Response: Thank you for your suggestion. We had planned on using sections of the template each week; not to use the complete template every week. We have divided this into weekly templates and have added these to the repository.

References
1.           Goodwin VA, Richards SH, Henley W, Ewings P, Taylor AH, Campbell JL. An exercise intervention to prevent falls in people with Parkinson's disease: a pragmatic randomised controlled trial. Journal of Neurology, Neurosurgery & Psychiatry. 2011;82(11):1232-1238.
Thank you very much for taking the time to review the study protocol. We appreciate your suggestions, many of which we have added, and we hope that we have addressed them appropriately. We have detailed the responses below.

Feasibility/methodology

Consider formulating progression criteria to better help you assess whether and how to progress to a full-scale RCT (see Mellor K, et.al.,2023 [Ref 1] for recommendations.)

Response: Thank you for your suggestion – it will be valuable step in our future pilot study.

Considering that the authors plan to perform a RCT on a smaller scale, and to assess most elements of this process, I would say that this is in fact a pilot RCT. How come the authors do not intend to use the results of this study to inform a larger scale RCT, instead of planning to perform yet another pilot study?

Response: Thank you for your query. As a team, we considered this quite extensively, and decided that there were too many unknowns for this to be a pilot study. To tease apart the different components was an important aim of the study, rather than to consider the intervention as one multicomponent intervention. Therefore, we decided to test the intervention as a feasibility study, allowing us to take the intervention apart, as such, and use the qualitative feedback to further inform our decisions.

Please consider evaluating the randomization process as well as the ability to maintain blinding throughout the study.

Response: Thank you for highlighting this. We agree that the methods can lead to bias. Unfortunately, for this study with existing resources, we are unable to change these, but will be considered for future studies, including the planned pilot.

Will the results of this study help inform the choice of a primary outcome for the planned RCT? If so, please describe how.

Response: We anticipate that the intervention may be further refined from this study. We plan to analyse for trends of change, and to examine which measures appear to be more sensitive to change, however, we do not anticipate that we will choose the primary outcome measure from this study. Our current focus is more on feasibility of data collection.

Participants/recruitment/screening

How will a diagnosis of idiopathic PD be confirmed?

Response: Thank you for bringing this to our attention. Idiopathic PD will be confirmed by a consultant neurologist or geriatrician. This is part of the referral process. We have added this in the text, under Participants and recruitment; Page 6, line 6.

How will Hoehn and Yahr stage be confirmed? Using the MDS-UPDRS III?

Response: Yes, that is correct – we have added this detail. - Page 6, line 7.

Fall risk and fall history will be assessed during pre-screening. Please describe the cut-off used to define “frequent falls”.

Response: We defined frequent falls as two or more falls in the last year, based on Goodwin et al.¹ and have added this to the exclusion criteria in the text - Page 6, line 23.

Have the authors considered excluding participants who are already highly physically active in their daily life? It is a common problem in exercise studies that people who are already active tend to sign up, thereby resulting in biased samples and lowered ability to show effect. If physically active people are recruited, please make sure participants are willing to continue with their usual exercise during the intervention period.

Response: Thank you for your suggestion. The main aim of this study was to test the feasibility of the data collection and the programme delivery. We are limited by time and resources. We will use this as an for the future RCT. We have added in the text that we will ask all participants to continue with their usual exercise during the intervention period – page 10, line 24

Outcomes/assessments

Have the authors considered evaluating cognitive function?

Response: We have not considered it for this feasibility study, but this will be considered for the future pilot study and RCT

Have the authors considered evaluating symptoms of depression or anxiety since this can negatively affect exercise adherence/motivation etc?

Response: Again, we have not considered it for this pilot, but going forward, we can see its value in future studies.

Why not use accelerometers the week after the intervention has ended, instead of letting participants wear them the last week of the intervention?

Response: We selected the last week of the intervention as we would be able to collect them easily from the participants at the last session, rather than ask them to return / send the accelerometers back to us. For earlier studies, we have experience of them being misplaced or lost. Many forget they are wearing them.

Perhaps just a typo, but I can only see two secondary outcome measures (6-min walk test and PDQ-39) even though the authors state that there should be four.

Response: Thank you for bringing this to our attention. We have corrected this, page 10, line 18.

What is the rationale for performing both the 2-minute walk test and the 6-minute walk test? Will both tests be performed at self-selected (i.e., usual) pace?

Response: We will perform the 2-minute walk test using the APDM data collection. The 6MWT will be performed separately to measure physical endurance. Yes, both are performed at self-selected pace. The report has been reworded to clarify this.

The authors state that the recommendation for the 6-minute walk test is to conduct it in an indoor hallway over a 10-meter distance, but this is not correct. The American Thoracic Society recommends it be performed over 100 ft (apx 30 meter). If possible, I therefore suggest that both the 2- and the 6-minute walk test be performed over a 30 meter distance.

Response: Thank you for this important information. We have begun data collection and are now delivering the programme. This will be recognised as a limitation of the study in the final report. In future studies, we will use a 30 m walkway, but will continue to use the 10m walkway to standardize among participants.

The TUG test is not described correctly (does not describe the first turn and the 3 meter walk back to the chair).

Response: Thank you for bringing this to our attention. We have corrected this, page 10, line 7

Why use five and not six opals? Please consider adding the sternum opal as well so that you can assess sit-to-stand/stand-to-sit transfers during the TUG.

Response: Thank you for your suggestion. We aim to keep the data collection as simple as possible. We decided this protocol based on the advice we received from colleagues in KU Leuven, who advised to collect the data using 5 opals.  Based on our results, we may add the additional sixth opal for future studies.

Intervention

Regarding the home exercise diary, I am curious as to how difficulty level will be explained to participants. Is this based on physical exhaustion or other? If so, have you considered letting participants rate this using for example Borg RPE instead?

Response: Thank you for your suggestion, we can see the value of this and have added it to the protocol, Page 10, line 5

The behavioural change template (Appendix B) seems a bit too exhaustive to complete in 2-5minutes. The authors state that not all questions will be addressed each week, but how will you choose which ones to focus on each week?

Response: Thank you for your suggestion. We had planned on using sections of the template each week; not to use the complete template every week. We have divided this into weekly templates and have added these to the repository.

References
1.           Goodwin VA, Richards SH, Henley W, Ewings P, Taylor AH, Campbell JL. An exercise intervention to prevent falls in people with Parkinson's disease: a pragmatic randomised controlled trial. Journal of Neurology, Neurosurgery & Psychiatry. 2011;82(11):1232-1238.
Competing Interests: Nil Close
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Version 2

VERSION 2 PUBLISHED 16 Feb 2024

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Reviewer Reports

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	1	2	3
Version 2 (revision) 29 May 24			read
Version 1 16 Feb 24	read	read

Hanna Johansson, Karolinska Institutet, Stockholm, Sweden
Chris Seenan, Glasgow Caledonian University, Glasgow, UK
Mark Manago, University of Colorado Denver Anschutz Medical Campus, Aurora, USA

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Reviewer Report

13 Views

18 Dec 2024 | for Version 2

Mark Manago, University of Colorado Denver Anschutz Medical Campus, Aurora, Colorado, USA

13 Views Cite this report Responses(0)

Approved

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Rehabilitation research in people with MS and PD

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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Reviewer Report

42 Views

14 May 2024 | for Version 1

Chris Seenan, Glasgow Caledonian University, Glasgow, Scotland, UK

42 Views Cite this report Responses(1)

Approved

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Yes

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

My expertise is within cardiovascular disease, physiotherapy and developing behaviour change interventions for long term conditions. I have experience designing and implementing feasibility trials in clinical practice.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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Reviewer Report

46 Views

08 May 2024 | for Version 1

Hanna Johansson, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden

46 Views Cite this report Responses(1)

Approved

Consider formulating progression criteria to better help you assess whether and how to progress to a full-scale RCT (see Mellor K, et.al.,2023 [Ref 1] for recommendations.)
Considering that the authors plan to perform a RCT on a smaller scale, and to assess most elements of this process, I would say that this is in fact a pilot RCT. How come the authors do not intend to use the results of this study to inform a larger scale RCT, instead of planning to perform yet another pilot study?
Please consider evaluating the randomization process as well as the ability to maintain blinding throughout the study.
Will the results of this study help inform the choice of a primary outcome for the planned RCT? If so, please describe how.

Participants/recruitment/screening

How will a diagnosis of idiopathic PD be confirmed?
How will Hoehn and Yahr stage be confirmed? Using the MDS-UPDRS III?
Fall risk and fall history will be assessed during pre-screening. Please describe the cut-off used to define “frequent falls”.
Have the authors considered excluding participants who are already highly physically active in their daily life? It is a common problem in exercise studies that people who are already active tend to sign up, thereby resulting in biased samples and lowered ability to show effect. If physically active people are recruited, please make sure participants are willing to continue with their usual exercise during the intervention period.

Outcomes/assessments

Have the authors considered evaluating cognitive function?
Have the authors considered evaluating symptoms of depression or anxiety since this can negatively affect exercise adherence/motivation etc?
Why not use accelerometers the week after the intervention has ended, instead of letting participants wear them the last week of the intervention?
Perhaps just a typo, but I can only see two secondary outcome measures (6-min walk test and PDQ-39) even though the authors state that there should be four.
What is the rationale for performing both the 2-minute walk test and the 6-minute walk test? Will both tests be performed at self-selected (i.e., usual) pace?
The authors state that the recommendation for the 6-minute walk test is to conduct it in an indoor hallway over a 10-meter distance, but this is not correct. The American Thoracic Society recommends it be performed over 100 ft (apx 30 meter). If possible, I therefore suggest that both the 2- and the 6-minute walk test be performed over a 30 meter distance.
The TUG test is not described correctly (does not describe the first turn and the 3 meter walk back to the chair).
Why use five and not six opals? Please consider adding the sternum opal as well so that you can assess sit-to-stand/stand-to-sit transfers during the TUG.

Intervention

Regarding the home exercise diary, I am curious as to how difficulty level will be explained to participants. Is this based on physical exhaustion or other? If so, have you considered letting participants rate this using for example Borg RPE instead?
The behavioural change template (Appendix B) seems a bit too exhaustive to complete in 2-5minutes. The authors state that not all questions will be addressed each week, but how will you choose which ones to focus on each week?
I think the authors have done a great job of describing both the control group and the intervention group, but I wonder whether it would be good to have a table outlining all elements as well to get a better overview of which elements are overlapping versus those that are group-specific.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

References

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Parkinsons disease

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

Respond to this report

Responses (1)

Author Response

11 Jun 2024

Leanne Ahern, Discipline of Physiotherapy, School of Clinical Therapies, University College Cork, Cork, Ireland

Thank you very much for taking the time to review the study protocol. We appreciate your suggestions, many of which we have added, and we hope that we have addressed them appropriately. We have detailed the responses below.

Feasibility/methodology

Consider formulating progression criteria to better help you assess whether and how to progress to a full-scale RCT (see Mellor K, et.al.,2023 [Ref 1] for recommendations.)

Response: Thank you for your suggestion – it will be valuable step in our future pilot study.

Considering that the authors plan to perform a RCT on a smaller scale, and to assess most elements of this process, I would say that this is in fact a pilot RCT. How come the authors do not intend to use the results of this study to inform a larger scale RCT, instead of planning to perform yet another pilot study?

Response: Thank you for your query. As a team, we considered this quite extensively, and decided that there were too many unknowns for this to be a pilot study. To tease apart the different components was an important aim of the study, rather than to consider the intervention as one multicomponent intervention. Therefore, we decided to test the intervention as a feasibility study, allowing us to take the intervention apart, as such, and use the qualitative feedback to further inform our decisions.

Please consider evaluating the randomization process as well as the ability to maintain blinding throughout the study.

Response: Thank you for highlighting this. We agree that the methods can lead to bias. Unfortunately, for this study with existing resources, we are unable to change these, but will be considered for future studies, including the planned pilot.

Will the results of this study help inform the choice of a primary outcome for the planned RCT? If so, please describe how.

Response: We anticipate that the intervention may be further refined from this study. We plan to analyse for trends of change, and to examine which measures appear to be more sensitive to change, however, we do not anticipate that we will choose the primary outcome measure from this study. Our current focus is more on feasibility of data collection.

Participants/recruitment/screening

How will a diagnosis of idiopathic PD be confirmed?

Response: Thank you for bringing this to our attention. Idiopathic PD will be confirmed by a consultant neurologist or geriatrician. This is part of the referral process. We have added this in the text, under Participants and recruitment; Page 6, line 6.

How will Hoehn and Yahr stage be confirmed? Using the MDS-UPDRS III?

Response: Yes, that is correct – we have added this detail. - Page 6, line 7.

Fall risk and fall history will be assessed during pre-screening. Please describe the cut-off used to define “frequent falls”.

Response: We defined frequent falls as two or more falls in the last year, based on Goodwin et al.¹ and have added this to the exclusion criteria in the text - Page 6, line 23.

Have the authors considered excluding participants who are already highly physically active in their daily life? It is a common problem in exercise studies that people who are already active tend to sign up, thereby resulting in biased samples and lowered ability to show effect. If physically active people are recruited, please make sure participants are willing to continue with their usual exercise during the intervention period.

Response: Thank you for your suggestion. The main aim of this study was to test the feasibility of the data collection and the programme delivery. We are limited by time and resources. We will use this as an for the future RCT. We have added in the text that we will ask all participants to continue with their usual exercise during the intervention period – page 10, line 24

Outcomes/assessments

Have the authors considered evaluating cognitive function?

Response: We have not considered it for this feasibility study, but this will be considered for the future pilot study and RCT

Have the authors considered evaluating symptoms of depression or anxiety since this can negatively affect exercise adherence/motivation etc?

Response: Again, we have not considered it for this pilot, but going forward, we can see its value in future studies.

Why not use accelerometers the week after the intervention has ended, instead of letting participants wear them the last week of the intervention?

Response: We selected the last week of the intervention as we would be able to collect them easily from the participants at the last session, rather than ask them to return / send the accelerometers back to us. For earlier studies, we have experience of them being misplaced or lost. Many forget they are wearing them.

Perhaps just a typo, but I can only see two secondary outcome measures (6-min walk test and PDQ-39) even though the authors state that there should be four.

Response: Thank you for bringing this to our attention. We have corrected this, page 10, line 18.

What is the rationale for performing both the 2-minute walk test and the 6-minute walk test? Will both tests be performed at self-selected (i.e., usual) pace?

Response: We will perform the 2-minute walk test using the APDM data collection. The 6MWT will be performed separately to measure physical endurance. Yes, both are performed at self-selected pace. The report has been reworded to clarify this.

The authors state that the recommendation for the 6-minute walk test is to conduct it in an indoor hallway over a 10-meter distance, but this is not correct. The American Thoracic Society recommends it be performed over 100 ft (apx 30 meter). If possible, I therefore suggest that both the 2- and the 6-minute walk test be performed over a 30 meter distance.

Response: Thank you for this important information. We have begun data collection and are now delivering the programme. This will be recognised as a limitation of the study in the final report. In future studies, we will use a 30 m walkway, but will continue to use the 10m walkway to standardize among participants.

The TUG test is not described correctly (does not describe the first turn and the 3 meter walk back to the chair).

Response: Thank you for bringing this to our attention. We have corrected this, page 10, line 7

Why use five and not six opals? Please consider adding the sternum opal as well so that you can assess sit-to-stand/stand-to-sit transfers during the TUG.

Response: Thank you for your suggestion. We aim to keep the data collection as simple as possible. We decided this protocol based on the advice we received from colleagues in KU Leuven, who advised to collect the data using 5 opals. Based on our results, we may add the additional sixth opal for future studies.

Intervention

Regarding the home exercise diary, I am curious as to how difficulty level will be explained to participants. Is this based on physical exhaustion or other? If so, have you considered letting participants rate this using for example Borg RPE instead?

Response: Thank you for your suggestion, we can see the value of this and have added it to the protocol, Page 10, line 5

The behavioural change template (Appendix B) seems a bit too exhaustive to complete in 2-5minutes. The authors state that not all questions will be addressed each week, but how will you choose which ones to focus on each week?

Response: Thank you for your suggestion. We had planned on using sections of the template each week; not to use the complete template every week. We have divided this into weekly templates and have added these to the repository.

References
1. Goodwin VA, Richards SH, Henley W, Ewings P, Taylor AH, Campbell JL. An exercise intervention to prevent falls in people with Parkinson's disease: a pragmatic randomised controlled trial. Journal of Neurology, Neurosurgery & Psychiatry. 2011;82(11):1232-1238.

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Competing Interests

Nil

Alongside their report, reviewers assign a status to the article:

Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested

Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.

Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions

[1] 1. van Nimwegen M, Speelman AD, Hofman-van Rossum EJ, et al.: Physical inactivity in Parkinson's disease. J Neurol. 2011; 258(12): 2214–21. PubMed Abstract | Publisher Full Text | Free Full Text

[2] 2. Dontje ML, de Greef MH, Speelman AD, et al.: Quantifying daily physical activity and determinants in sedentary patients with Parkinson's disease. Parkinsonism Relat Disord. 2013; 19(10): 878–882. PubMed Abstract | Publisher Full Text

[3] 3. Ramaswamy B, Jones J, Carroll C: Exercise for people with Parkinson’s: a practical approach. Pract Neurol. 2018; 18(5): 399–406. PubMed Abstract | Publisher Full Text

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Behavioural change for Parkinson’s Disease: A randomised controlled feasibility study to promote physical activity and exercise adherence among people with Parkinson’s: study protocol

Abstract

Background

Objective

Methods

Discussion

Trial Registration

Keywords

Revised Amendments from Version 1

Introduction

Research objectives

Methods

Patient and Public Involvement (PPI)

Study design

Participants and recruitment

Randomisation

Figure 1. Consort Flow Diagram detailing the participants planned pathway through the trial25.

Table 1. Participant Timeline.

Usual care and intervention details

Outcomes measures

Table 2. Overview of feasibility outcomes31.

Data collection

Data analysis

Dissemination of data

Amendments

Ethical application

Study status

Discussion

Data availability

Underlying data

Extended data

Reporting guidelines

References

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Open Peer Review

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Reviewer Reports

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Figure 1. Consort Flow Diagram detailing the participants planned pathway through the trial²⁵.

Table 2. Overview of feasibility outcomes³¹.