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Study Protocol

Implementation evaluation of community-based physical activity programmes for secondary prevention following stroke in Ireland: a RE-AIM and CFIR-informed mixed-methods study protocol using ExWell Medical as a case study.

[version 1; peer review: awaiting peer review]
PUBLISHED 23 Jun 2026
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Abstract

Background

Stroke is a leading cause of mortality and long-term disability globally and in Ireland, with prevalence rising due to population ageing. Physical activity is a key component of secondary prevention and recovery; however, there is limited evidence on how community-based exercise programmes are implemented, delivered, and sustained in routine practice. Addressing these gaps is essential to inform national policy and service planning, particularly within the context of Sláintecare and the Health Service Executive’s National Stroke Strategy. This implementation evaluation forms part of the broader INsPIRE (Informing National Policy for Physical Activity-based Secondary Prevention of Stroke in Ireland) project, which aims to generate policy-relevant evidence on scalable and sustainable models of community-based physical activity.

Methods

This protocol outlines a mixed-methods implementation evaluation using ExWell, a community-based exercise programme, as a real-world case study. The study is guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework and the Consolidated Framework for Implementation Research (CFIR 2.0). Quantitative outcomes include referral patterns, programme uptake, retention and engagement with the ExWell programme. Qualitative data will be collected from stroke survivors, programme staff, referring clinicians, and stakeholders through semi-structured interviews and focus groups to explore contextual determinants influencing implementation.

Analysis

Quantitative data will be analysed using descriptive and inferential statistics, while qualitative data will undergo reflexive thematic analysis. A convergent mixed-methods approach will integrate findings to examine implementation outcomes and contextual influences. Secondary analysis of existing datasets will support benchmarking.

Discussion

This study will generate implementation-focused evidence on the delivery, uptake, and sustainability of community-based physical activity programmes for stroke survivors in Ireland, informing policy, resource allocation, and equitable service design aligned with national health policy ‘Sláintecare’ objectives.

Keywords

Stroke survivors, Secondary prevention, Community-based, Implementation science, Health policy, Physical activity, Service delivery, Exercise

Introduction

Stroke remains a leading cause of mortality and long-term disability worldwide, affecting 94 million people globally, approximately 10 million in Europe, and an estimated 57,000 individuals in Ireland.13 Around 7,500 Irish people experience a stroke each year, and more than half of survivors live with persistent physical, cognitive or emotional impairment.4 Most strokes are ischaemic in origin, and recurrence is common, with international estimates indicating that approximately 20% of people experience a further ischaemic event and 12% a recurrent haemorrhagic stroke.3

Demographic change is expected to intensify this burden over the coming decades. Wafa et al. (2020) projects that approximately 2.4% of the European Union population would be living with stroke by 2047, representing a 27% increase in prevalent stroke cases compared with 2017.3

Added to this, Ireland’s rapidly ageing population will likely have a knock-on impact of increased service demand and costs.2 Stroke-related healthcare expenditure in Ireland was estimated at €172 million in 2017 and is forecast to rise sharply over the next two decades.2 As survival improves, the challenge for health systems increasingly concerns the organisation, delivery and sustainability of effective secondary prevention and long-term recovery supports in community settings.4,5

Behavioural factors such as physical inactivity, poor diet and smoking account for 35% of stroke burden.1 European and national policy frameworks position physical activity as central to post-stroke recovery and secondary prevention. The European Stroke Organisation and the Stroke Action Plan for Europe 2018–2030 emphasise the importance of exercise-based rehabilitation and set a target that all stroke survivors living in the community should have access to physical fitness programmes by 2030.6 In Ireland, the Health Service Executive’s National Stroke Strategy 2022–2027 prioritises multidisciplinary, person-centred models of care that extend beyond inpatient rehabilitation, with secondary prevention and long-term recovery identified as core components of service provision.7 The National Clinical Guidelines for Stroke further recommends that stroke survivors participate in tailored exercise programmes incorporating combined aerobic and resistance training delivered over sustained periods.8

Despite this policy consensus, significant implementation challenges persist. Stroke services continue to be characterised by discontinuities between acute and community sectors, variable referral pathways, and constrained workforce capacity, particularly outside hospital settings. At the same time, Ireland’s Sláintecare reform programme prioritises delivery of care closer to home through strengthened community services and integrated pathways, reinforcing the case for community-based secondary prevention models and highlighting the need for robust implementation-focused evidence to guide decisions on scale-up, resourcing and service configuration.9,10

The evidence base supporting physical activity following stroke continues to grow. Engagement in cardiovascular exercise has been associated with reduced risk of hospitalisation among stroke survivors, and individuals with mild stroke or transient ischaemic attack who remain physically active may have substantially lower risk of recurrence.11,12 Exercise interventions improve vascular risk profiles and physical function, particularly walking ability and mobility13 while group-based programmes delivered in community settings may offer additional psychosocial benefits such as peer support and social connectedness.14 The most comprehensive systematic evidence to date includes a recent Cochrane review of physical rehabilitation approaches after stroke, which found that interventions incorporating structured physical activity and mobility training likely improve functional outcomes such as independence in activities of daily living and motor function, though the certainty of evidence is generally low to moderate and differences between specific approaches remain uncertain.15 A separate Cochrane review of resistance training programmes concluded that evidence is currently inadequate to determine effects on mortality or disability, though resistance exercise appears to safely increase muscle strength and may offer small improvements in balance and other physical outcomes.16 Collectively, these syntheses support the role of structured exercise in post-stroke recovery while highlighting persistent uncertainties regarding psychological and quality-of-life outcomes and the limited understanding of how effective interventions can be translated into routine community practice.

Against this backdrop, a critical challenge for Irish stroke services is not whether physical activity should be promoted, but how community-based physical activity programmes are implemented in routine practice, who they reach, and what organisational and system-level factors shape sustainability. Generating such implementation-relevant evidence is essential to inform national planning, investment decisions and future rollout of community-based physical activity programmes in line with Ireland’s stroke policy and Sláintecare objectives.

The Informing National Policy for physical activity based secondary prevention of stroke in IREland (INsPIRE) project was awarded funding in 2026 under a Health Research Board Evidence for Policy (EfP) funding call. HRB EfP grants are designed to address a specific policy question for key decision makers in the Department of Health. The goal of INsPIRE is to generate timely, policy-relevant evidence on effective strategies for promoting physical activity in the community for secondary prevention following stroke.

A core aspect of the INsPIRE programme adopts a theory-informed implementation evaluation using RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance17; and the Consolidated Framework for Implementation Research (CFIR)18 to examine how community-based physical activity programmes for people living after stroke are delivered, adopted and sustained within the Irish context, focusing in particular on the ExWell programme as a real-world case study. These complementary frameworks draw on theory relating to the uptake, delivery and long-term integration of evidence-based interventions and implementation strategies. Their combined application supports systematic specification of implementation outcomes using RE-AIM, alongside in-depth exploration of the contextual, organisational and system-level determinants shaping variation in adoption, delivery and sustainability through CFIR. Together, they provide an integrated analytic approach aligned with a central aim of INsPIRE which is to generate implementation-relevant evidence to support national decision-making on the scalable, equitable and sustainable delivery of community-based physical activity programmes for secondary prevention following stroke. Specifically, this aspect of the research will assess programme reach, including referral pathways, participation patterns and representativeness; examine adoption across delivery sites and referral sources, including implementation readiness; evaluate implementation processes, including adaptation, acceptability and feasibility; and assess maintenance with attention to sustainability and delivery capacity.

This protocol is informed by the Standards for Reporting Implementation Studies (StaRI). While StaRI is intended for reporting completed implementation studies, its core principles, particularly the distinction between the programme and the implementation strategy, have shaped the design and analytic logic of INsPIRE.19 Any subsequent policy synthesis will be informed by GRADE Evidence-to-Decision frameworks.20

Protocol

Study design

This is a mixed methods implementation evaluation of community-based physical activity programmes for secondary prevention of stroke using ExWell Medical as a real-world case study.

ExWell programme description

ExWell is a not-for-profit community-based organisation that delivers structured, group-based exercise programmes for adults living with chronic conditions. The programme operates under medical oversight, with classes delivered by exercise professionals certified by the British Association of Cardiovascular Prevention and Rehabilitation (BACPR), including individuals with backgrounds in physiotherapy, sports science and exercise physiology. ExWell currently operates in over 60 locations across Ireland covering both urban and rural locations.

Participants include adults living with various chronic illnesses, including stroke, who are referred to the programme by healthcare professionals or through social prescribing pathways. Prior to commencing classes, all participants attend a group induction session conducted by an ExWell physician or physiotherapist. This session includes orientation to the programme and baseline assessment of physical function and self-reported health outcomes. The programme consists of supervised group exercise classes incorporating standardised elements: warm-up, aerobic training, resistance exercises, balance and core stability components, and cool-down. Participants are encouraged to attend two supervised 1-hour sessions per week, with repeat assessment conducted at 12 weeks to monitor progress and outcomes. Participants can continue to attend classes for as long as they wish. Following the 12-week re-assessment, subsequent assessments occur bi-annually during the summer and again during the winter. In addition to the supervised exercise component, the programme incorporates elements designed to support social engagement and health education. These include opportunities for informal peer interaction (e.g., post-class tea and coffee), weekly online educational seminars, and regional and national health fairs and workshops. Participants typically pay €7.50 per class, with variation depending on location and funding.

ExWell case study

In 2024, ExWell received grant funding for a stroke-specific study from the Cardiovascular Policy Unit of the Department of Health. Details of the ExWell Stroke study which will be used as a case study for the INsPIRE project is outlined in Table 1. In addition, ExWell previously received funding to conduct a prospective cohort study (ExWell CHO7 cohort study, See Table 1). Secondary analysis of relevant data from both studies will inform INsPIRE where appropriate.

Table 1. Overview of the ExWell Stroke study and ExWell CHO7 cohort study.

ExWell Stroke study

The ExWell Stroke study is a feasibility study evaluating the adaptation and impact of a community-based exercise rehabilitation programme for people living post-stroke in Ireland. The ExWell Stroke study comprises three stages:

Stage 1: Information gathering
Data will be collected from stroke survivors referred to ExWell (including attenders, dropouts, and non-engagers), ExWell staff, and stroke physiotherapists to identify areas for programme improvement.
Stage 2: Programme modification and staff training
Findings from Stage 1 will inform programme adaptations and the development of a staff training programme.
Stage 3: Programme implementation and evaluation
The modified programme will be implemented and evaluated over 12 months, examining participant outcomes, engagement, adherence, experience, and dropout.

ExWell CHO7 cohort study

This was a prospective cohort study exploring outcomes in 1200 participants attending the ExWell programme in Dublin West and Kildare. Assessments were conducted at baseline, 12 weeks and 6 month follow up. A range of data was collected including physical fitness measures, patient reported outcome measures and process outcomes including attendance and class retention. Data is available for a sub-group of participants with a history of stroke.

INsPIRE will leverage the ExWell stroke study as a real-world case study and draws on implementation science frameworks to generate policy-relevant evidence for national planning of community-based physical activity programmes for stroke survivors. The conceptual and reporting frameworks, along with the key outcomes for the implementation evaluation, are outlined below.

Conceptual and reporting frameworks

INsPIRE is informed by two implementation science frameworks selected to support policy-relevant evaluation rather than efficacy testing. Firstly, the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation and Maintenance) is used as the primary organising framework for implementation outcomes. RE-AIM was developed to evaluate the population-level impact of health interventions and is particularly well suited to evaluations intended to inform national scale-up, as it structures assessment around population reach, organisational uptake, delivery in routine practice and long-term sustainability.2123 Within INsPIRE, Reach, Implementation and Maintenance are prioritised to reflect the central importance of equity, fidelity and sustainability to national rollout decisions.

Secondly, the Consolidated Framework for Implementation Research (CFIR) version 2.0 is used as an explanatory framework to guide qualitative data collection and analysis, supporting systematic examination of multilevel contextual determinants influencing adoption, delivery and sustainability across intervention characteristics, inner and outer settings, characteristics of individuals and implementation processes.24,25

In this study, RE-AIM is used to pre-specify and structure implementation outcomes, while CFIR is used to explain observed variation in implementation through analysis of contextual determinants across delivery settings.

Study setting

This study utilises the ExWell Medical Programme as a real-world case study and where possible, findings will be benchmarked against the secondary analysis of data from the ExWell CHO7 cohort study.

Participants

Participants will include:

  • Stroke survivors referred to ExWell (Including those who engage with the ExWell programme, dropouts and non-attenders).

  • ExWell staff involved in programme delivery

  • Referring clinicians and healthcare professionals

  • Stakeholders and policymakers

Sample size and sampling strategy

The sample size for each component of this implementation evaluation will be determined by the real-world flow of participants through ExWell, reflecting the stages of referral, induction, programme commencement, 3-month and 6-month follow-up. This approach enables examination of reach, uptake, retention, and maintenance across the full participant pathway, rather than relying on fixed recruitment targets.

For the quantitative data, a minimum of 4 months of referral records from ExWell will be tracked. Based on current programme engagement, this is estimated to be 8000 referrals, of which, approximately 450 are likely to be stroke survivors.

For the qualitative data, approximately 30 stroke survivors, 10–15 referring clinicians, national stroke rehabilitation stakeholders and policymakers and 20–30 ExWell staff will be recruited for semi-structured interviews and focus groups. A purposive sampling strategy will be used to capture a range of stakeholder and policymaker’s perspectives.

Sample size will be guided by data availability and the principle of information power, ensuring sufficient depth and diversity to examine implementation processes, contextual influences, and outcomes across the pathway within the time and funding constraints of the study.

Data collection

Quantitative data will be collected using ExWell referral and engagement records to track the participant journey from point of referral to induction, programme initiation and programme continuation or dropout. This data capture method will be piloted.

Qualitative data will include semi-structured interviews with stroke survivors, referring clinicians, national stroke rehabilitation policy advisors and stakeholders and focus groups with ExWell staff. Written informed consent will be obtained from participants prior to any data collection.

Interviews and focus groups will be facilitated using a semi-structured topic guide informed by CFIR and RE-AIM domains, exploring perceptions of programme acceptability, feasibility, barriers and facilitators to implementation, and integration within existing care pathways. Discussions will be audio-recorded and transcribed verbatim, with field notes taken to capture contextual and interactional dynamics. Data collection will continue until sufficient depth and diversity of perspectives are achieved to support robust thematic analysis and interpretation.

Secondary analysis of the CHO7 dataset will be conducted to benchmark referral, engagement, and retention outcomes. The ExWell CHO7 cohort study was a feasibility study exploring processes and impact of the ExWell Programme within the Dublin West and Kildare region and included a cohort of 1200 participants inducted into the ExWell programme. Outcomes included quantitative data on participant characteristics, referral rates, uptake, engagement and dropout from the ExWell programme. Due to the inclusion of chronic disease classifications, stroke-specific outcomes can be compared with the overall cohort and with prospectively collected study data from the current study.

Table 2 provides further detail on the various data sources and key outcomes that will be evaluated for this study.

Table 2. Data sources and key outcome measures.

Quantitative data sources ExWell Stroke studyKey outcomes
ExWell referral, attendance and retention records
(All referrals to the ExWell programme will be prospectively tracked for a minimum of 4 months. Key metrics for those with a stroke diagnosis will be assessed from point of referral to 3- and 6-month follow-up).

  • Stroke referrals: what proportion of referrals to the ExWell programme have a stroke diagnosis?

    • For what proportion is the stroke diagnosis the primary reason for referral to the ExWell programme?

    • Source of stroke referrals (e.g. GP, Specialist stroke teams, primary care etc.)

    • Are there variations in the volume of stroke referrals by region/centre?

  • Contact outcome (i.e. when contacted by ExWell to attend an induction, what percentage of stroke referrals accept, decline or defer an invite or are not contactable)?

  • Induction attendance: what percentage of stroke referrals who accept an invite to an induction attend the induction?

  • Programme start: what proportion of those who attend an induction start classes within two weeks?

Those who do not start within 2 weeks will be contacted by ExWell, of those

  • What proportion of non-starters do start when contacted (having been identified as non-starters)?

  • What reasons are given by non-starters for not starting?

  • Retention rates: what proportion of those who started classes, are still attending at 3 and 6 months?

  • Dropouts: what proportion of those who started classes dropout? (dropout defined as a participant who starts the ExWell programme but stops attending for ≥4 consecutive weeks)

Those who dropout of the programme for 4 weeks will be contacted by ExWell, of those

  • What proportion re-engage when contacted?

  • What reasons were given for dropout by those who reengage?

  • What reasons were given for dropout by those who do not reengage?

  • Attendance dose: number of sessions attended within 3 months and 6 months

  • Timelines: average time

    • From referral to induction

    • From induction to class start

    • From class start to dropout

Other metrics

  • What is the Functional ambulation capacity of the stroke participants who attend an induction?

    • Is functional ambulation capacity linked to engagement or dropout?

  • What proportion of those who attend inductions use mobility aids? (is this linked to engagement/dropout)

  • What proportion need assistance to participate?

  • What proportion have a personal carer/aide/family member available to come with them to classes?

Stroke survivors
Semi-structured interviews
Interviews with stroke survivors who participated in the amended ExWell programme

  • Referral and access pathway

  • Fit and acceptability of the programme

  • Perceived Impact (secondary prevention focus)

  • Barriers and facilitators to participation

  • Long-term engagement and sustainability

  • Broader system perspective

Interviews with stroke survivors prior to amended ExWell programme (secondary data analysis)
Note: during the data collection phase of the ExWell stroke study, interviews were conducted with stroke survivors who attended, dropped out and did not engage with the ExWell programme. Secondary analysis of these transcripts will be utilised for the current study if useful.

  • Pre-stroke health and lifestyle

  • The experience of living with a stroke

  • Participation in the ExWell programme

  • Barriers to the ExWell programme

  • Gender and participation

Referring clinicians
Semi-structured interviews
Interview Guide

  • Role and referral context

  • Knowledge and perceptions of ExWell

  • Referral pathways and equity of access

  • Fit with existing stroke care pathways

  • Delivery capacity and workforce

  • Sustainability and feedback

Policy advisors/Stakeholders
(e.g. Department of Health, HSE national programme lead, guideline developers, stroke networks)
Semi-structured interviews
Interview Guide

  • Role and policy context

  • Strategic value of ExWell community models

  • System integration

  • Leadership, governance and accountability

  • Sustainability and long-term funding

  • Monitoring, evidence and learning

  • Scale-up and national spread

ExWell delivery staff
Focus groups
Interview Guide

  • Understanding stroke and its impact

  • Confidence in working with stroke survivors

  • Adequacy of ExWell’s support for stroke survivors

  • Suggestions for improvement

Secondary data analysis
ExWell CHO7 cohort study
Secondary analysis of the CHO7 dataset will act as a benchmark by comparing uptake, attendance and retention data for stroke survivors with the overall cohort data and with prospectively collected data from the current study.

Data analysis

Quantitative data will be summarised using descriptive statistics and where appropriate, analysed using paired statistical tests and/or mixed-effects models.

Qualitative findings will be explored using reflexive thematic analysis as outlined by Braun and Clarke.26 All transcripts will be imported into NVivo (Version 15), and key themes and concepts will be identified using an iterative process. The analysis will follow a six-stage coding framework consisting of: data familiarisation, development of initial codes, identification of potential themes, review of themes, refinement and naming of themes, and preparation of the final analysis. Members of the research team (CD, LK, and FS) will independently review the transcripts. Researchers will conduct detailed line-by-line coding, supported by the AI-assisted features available within NVivo 15, to allocate preliminary a priori themes and relevant excerpts, with particular attention to participants’ experiences, perspectives, and concerns. Emerging patterns within the dataset will then be organised into a thematic framework to establish overarching themes and subthemes.26

Following the initial coding process, the research team will meet to discuss and resolve any uncertainties or discrepancies until agreement is achieved. Direct quotations will be incorporated to illustrate the identified themes and strengthen the trustworthiness of the findings.

The analytic emphasis will be on producing policy-relevant insights concerning how such programmes can be commissioned, integrated within care pathways and sustained at scale within the Irish health system. These data will inform analysis within RE-AIM domains and will be interpreted using CFIR constructs relating to organisational readiness, resource availability, leadership engagement and pathway integration.

Data integration

A convergent mixed-methods approach will be used. Quantitative and qualitative data will be analysed separately and integrated during interpretation to provide a comprehensive understanding of implementation outcomes such as implementation strategies and contextual conditions associated with sustained delivery of community-based physical activity programmes for stroke secondary prevention.

Findings from this aspect of the INsPIRE project will contribute to subsequent synthesis using the GRADE Evidence-to-Decision (EtD) framework, which supports transparent policy recommendation development through consideration of effectiveness, cost-effectiveness, feasibility, acceptability, equity and costs. A full range of potential conflicts of interest will be explored prior to the EtD process, including financial, professional and personal interests. A full protocol for the EtD process will be conducted in WP3 which will provide more detail on the types of stakeholders who will be included and declarations of potential conflicts of interest.

Discussion

This protocol outlines a theory-informed implementation evaluation designed to support national policy and service planning for community-based physical activity programmes for secondary prevention following stroke. By focusing on implementation rather than efficacy, we will address critical evidence gaps related to service availability, delivery, equity and sustainability within the Irish health system.

Use of RE-AIM structures implementation outcomes in a way that aligns with scale-up decisions, while CFIR supports systematic understanding of contextual determinants influencing adoption and sustainability.17,18 Our findings will directly inform economic analysis and policy synthesis within INsPIRE, supporting the development of feasible, context-sensitive recommendations for national implementation.

Ethical considerations

Ethical approval has been granted by the St James’s Hospital and Tallaght University Hospital Joint Research Ethics Committee (Project ID 4517, Submission Number 5361, Approval date 13th April 2026).

All participants will provide informed consent. Data will be managed in accordance with data protection regulations.

Dissemination

Findings will be disseminated through peer-reviewed publications, conference presentations, and stakeholder engagement, with the aim of informing the scale-up of community-based physical activity programmes for stroke survivors.

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Kelly L, Skelly F, Segerström V et al. Implementation evaluation of community-based physical activity programmes for secondary prevention following stroke in Ireland: a RE-AIM and CFIR-informed mixed-methods study protocol using ExWell Medical as a case study. [version 1; peer review: awaiting peer review]. HRB Open Res 2026, 9:67 (https://doi.org/10.12688/hrbopenres.14470.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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VERSION 1 PUBLISHED 23 Jun 2026
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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

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