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Study Protocol

Oral nutritional supplement combined with an online resistance training programme to improve physical function and nutritional status in older adults receiving home care and at risk of sarcopenia:  protocol for the randomised controlled POWER trial

[version 1; peer review: awaiting peer review]
Catherine M. Fallon
https://orcid.org/0009-0000-7408-7661
1,2, Caitriona G. Cunningham
https://orcid.org/0000-0002-8916-9499
1, Katy Horner
https://orcid.org/0000-0002-5046-3658
1,2, Clare A. Corish1,2
Catherine M. Fallon
https://orcid.org/0009-0000-7408-7661
1,2, Caitriona G. Cunningham
https://orcid.org/0000-0002-8916-9499
1, Katy Horner
https://orcid.org/0000-0002-5046-3658
1,2, Clare A. Corish1,2
PUBLISHED 17 Mar 2025
Author details Author details
OPEN PEER REVIEW
REVIEWER STATUS AWAITING PEER REVIEW

This article is included in the Ageing Populations collection.

Abstract

Background

The aim of the POWER trial is to investigate the effects of a whey protein oral nutritional supplement (ONS) combined with an online resistance training (RT) programme compared to RT alone on physical function, nutritional status and health-related outcomes in community-dwelling older adults receiving supportive home care who are at risk of sarcopenia.

Methods

This home-based, randomised controlled trial will include older adults aged ≥70 years, receiving supportive home care (professional and/or informal), who will be screened for sarcopenia via telephone. Forty-six participants will be randomised into either (i) ONS + RT or (ii) RT only trial arms. Participants in the ONS + RT group will be provided with a whey protein ONS enriched with leucine and vitamin D to consume twice a day for 12 weeks. All participants will be provided with an online RT programme twice a week via Zoom. The primary outcomes are physical function, measured using the Timed Up and Go test and nutritional status, measured using the Mini-Nutritional Assessment-Full Form. Secondary outcomes include body composition, dietary intake, gait speed, muscle strength, cognitive function, depression risk, activities of daily living, quality of life and feasibility of intervention implementation. All outcomes will be measured at baseline, after and 12 weeks post-intervention.

Conclusion

This study will provide data on the effectiveness of a whey protein ONS enriched with leucine and vitamin D combined with an online RT programme delivered via Zoom, compared to the RT programme alone, for older adults at risk of sarcopenia and receiving supportive home care.

Trial registration

NCT05688956; registered December 2022.

Keywords

older adults, home care, sarcopenia, oral nutritional supplement, online resistance training

Corresponding author: Catherine M. Fallon
Competing interests: No competing interests were disclosed.
Grant information: This work was supported by Nutricia Ireland Limited.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Copyright:  © 2025 Fallon CM 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: Fallon CM, Cunningham CG, Horner K and Corish CA. Oral nutritional supplement combined with an online resistance training programme to improve physical function and nutritional status in older adults receiving home care and at risk of sarcopenia:  protocol for the randomised controlled POWER trial [version 1; peer review: awaiting peer review]. HRB Open Res 2025, 8:41 (https://doi.org/10.12688/hrbopenres.14086.1) First published: 17 Mar 2025, 8:41 (https://doi.org/10.12688/hrbopenres.14086.1) Latest published: 17 Mar 2025, 8:41 (https://doi.org/10.12688/hrbopenres.14086.1)

Background

Muscle loss is caused by a discrepancy between muscle protein synthesis and muscle protein breakdown1, which can be contributed to by ageing, inadequate nutrition and physical inactivity2,3. Sarcopenia is an age-related condition defined by the European Working Group on Sarcopenia for Older People (EWGSOP) as low muscle strength, mass and physical function1. This can lead to reduced ability to carry out activities of daily living (ADLs), falls, loss of independence, hospitalisation, disability and death4,5. When physical function significantly deteriorates, supportive formal or informal home care to perform ADLs may be required6,7.

Currently, the reported prevalence of sarcopenia among community-dwelling older adults (≥60 years) ranges from 5–10%8–10. Within residential care homes, reported sarcopenia prevalence is between 17–73%, and from 22–87% within assisted living facilities11. Older adults’ response to protein12–14 and resistance training (RT)2,15 is blunted compared to the response of healthy younger populations. With reduced mobility, anabolic resistance is further exacerbated in older adults13,16. The relationship between sarcopenia and undernutrition is complex, with the development of one interlinked with the other2,5. Undernutrition, mainly when there is insufficient energy and/or protein, contributes to muscle protein breakdown3,5. Older community-dwelling adults receiving home care are more frequently undernourished [14.9%, 95% CI: 9.9–20% compared to those not requiring home care 4.7%, 95% CI: 3.6–6.1%]17.

To increase muscle strength and mass, nutritional interventions and/or RT are recommended18,19. The functional benefits of taking part in RT include improved mobility, performance in ADLs, resistance to injuries and falls and enhanced overall quality of life in older adults20–23,. Mobility limitations can persist in individuals who are at a higher risk of lower protein intake (<0.8 g/kg adjusted bodyweight/day)24. Older females, with higher BMI and poor appetite are at higher risk of inadequate protein intakes25. Increasing energy26,27 and protein (1–1.5 g/kgBW/day)26–28 intakes to prevent malnutrition and muscle loss is recommended for older adults26–28. To further stimulate muscle protein synthesis, increasing leucine intake by up to 2.8–3 g twice/day is recommended29,30. Older adults residing in the Northern Hemisphere should also take a daily vitamin D supplement (15 µg for healthy older adults and 20 µg for home bound older adults)19,31–33. Providing ONS fortified with whey protein, leucine and vitamin D has shown promise in improving health-related outcomes34,35 while such ONS combined with RT in older adults with sarcopenia have shown positive effects on muscle strength, body composition and physical function34.

Older adults with sarcopenia, undergoing physical rehabilitation, demonstrated improvements in physical function [Timed Up & Go (TUG) and gait speed) and nutritional status (Mini-Nutritional Assessment-Full Form (MNA-FF)] following 8 weeks of ONS enriched with leucine and vitamin D and supervised RT compared to an isocaloric placebo supplementation and supervised RT36. These findings demonstrate the added benefits of nutritional supplementation to improve outcomes of an exercise programme in hospitalised older adults. However, whether similar effects are observed in older adults receiving supportive home care is unknown. Older adults with sarcopenia are recommended to perform at least two RT sessions per week18,37. Given that a number of studies indicate older adults are less likely to engage in exercise programmes for varying reasons38,39, supervised exercise programmes delivered via an online platform are worth considering40,41. Online platforms such as Zoom provide a potential and accessible solution for older adults who have mobility and/or transportation limitations41–43. Providing a supervised and consistent programme can improve adherence44 plus the group-based aspect can provide a social element41. Recent studies indicate overall acceptability of online exercise programmes among healthy older adults41,44.

Therefore, the aim of this study is to test the effectiveness of a novel whey protein ONS enriched with leucine and vitamin D (Fortimel Advanced, Nutricia) combined with an online RT programme versus the RT programme alone on the physical function and nutritional status of older adults who are at risk of sarcopenia and receiving supportive home care. The primary outcomes of the study are 1) physical function as measured by the TUG and 2) nutritional status as measured by the MNA-FF.

Trial registration: NCT05688956; registered December 2022.

Methods

Study design

This randomised, parallel group, 12-week clinical trial will include 46 community-dwelling (residing in either an urban or rural setting in their own home) older adults who receive supportive home care and are at risk of sarcopenia. Participants will be randomly allocated to either the (i) ONS + RT or (ii) RT only trial arm. Screening potential participants will be undertaken via telephone. Baseline and follow-up assessments will be undertaken in the participant’s own home. Post-intervention testing will be conducted immediately after the final RT session and again 12 weeks later. The study design and participant flow chart are shown in Figure 145.

87693e09-b323-4547-b636-b36f44a7a8b1_figure1.gif

Figure 1. Study design and participant flow.

Sample size

Study sample size calculation was conducted in G* Power (version 3.1). Based on previous study findings36, 15 participants per group are required to detect a mean difference of 3.7 seconds in time to complete TUG with 80% power and significance at p<0.05. Additionally, based on the same findings36, 16 participants per group will be needed to detect a mean difference of 1.52 in MNA-FF score between the intervention group and the control group with 80% power and significance at p<0.05. To ensure an adequate sample size to enable per protocol analysis, the sample size was increased to 23 participants per group46. This will allow for both intention-to-treat and per-protocol analyses, ensuring rigorous analysis of intervention effectiveness.

Eligibility criteria, recruitment and screening

Older adults who are ≥70 years old, community-dwelling and receiving regular supportive home care from a professional and/or informal carer47 will be invited to take part in the research study. A variety of recruitment techniques will be employed including contacting home care associations, media coverage, poster distributions and face-to-face strategies such as presenting at community centres, day centres and exhibition shows for older adults. Non-profit organisations and charities that support older adults will also be contacted and asked to share information about the study. The inclusion and exclusion criteria are summarised in Table 1. Individuals will be screened for eligibility using two screening questionnaires conducted via telephone: i) SARC-F questionnaire with a cut-off score of ≥1 (out of 10) to screen for risk of sarcopenia48 (Table 1) and ii) the Physical Activity for Readiness Questionnaire for Everyone (PARQ+) to assess participants’ readiness to participate in exercise.

Table 1. Inclusion and exclusion criteria for the POWER Study.

Inclusion CriteriaExclusion Criteria
1. Older adults (70+ years)
2. Community-dwelling
3. Receiving supportive home care
(professional and/or informal)
4. At risk of sarcopenia (SARC-F ≥1)48

1. Cognitive impairment (MMSE <24)49
2. Severe kidney disease (glomerular filtration rate <30 mL/min)
3. Moderate to severe liver disease (Child-Pugh class B or C)
4. Psychiatric disorder
5. Receiving active treatment or palliative care for cancer
6. Receiving enteral or parenteral nutrition
7. Known hypersensitivity to any component of the ONS
8. Currently consuming ONS
9. Allergic to dairy products
10. Regularly undertaking resistance training
11. Advised by GP not to undertake exercise

Randomisation and blinding

On meeting the eligibility criteria, participants will be randomised into either the (i) ONS + RT or (ii) RT only, using a 1:1 ratio by an independent researcher not involved in the POWER study using the Clinical Trial Randomization Tool hosted by the National Cancer Institute. Eligible participants will be assigned an identification number and then added to the study database. It will not be possible to blind the participant or researchers to the intervention allocation.

Interventions

Oral Nutritional Supplements

Participants randomised to ONS + RT will consume two 200 mL bottles of whey-based protein ONS enriched with the amino acid leucine and vitamin D each day50. Participants will be instructed to consume the ONS as soon as possible after the RT session and on non-exercise days, the most appropriate time for consumption to optimise potential muscle protein synthesis will be based on a 24-hour dietary recall, undertaken at the baseline assessment51. The nutritional content of the ONS (Fortimel Advanced, Nutricia) per 200 mL includes: energy: 300 kcal; protein: 20.8 g; leucine: 3 g; fat: 10.4 g; carbohydrate: 30 g; dietary fibre: 2.8 g; vitamin D: 10 µg (Appendix B)45.

Dietary advice

All participants and home support person, if required, will be provided with written dietary information (“Making the Most of Every Bite”, a high energy and protein cookbook, available from the Irish Health Service Executive). Additional dietary advice will be provided verbally.

Online resistance training programme

A 12-week, progressive, group RT programme, developed with a registered physiotherapist and an exercise physiologist, will be delivered to all participants in their own home via Zoom twice per week by a health science researcher with exercise training (Exercise Instructor). Each RT session will last approximately 45–60 minutes, will include a warm-up and cool-down and moderate to high intensity RT exercises rated on the 10 point Borg Rating of Perceived Exertion (RPE) scale52. During the baseline assessment, the exercises will be demonstrated, and the appropriate RT load will be determined using the 5- Repetition Maximum method53.

The RT programme will include upper and lower body strengthening exercises, which can be modified to each participant’s muscle function, aiming for 2–3 sets of 8–12 repetitions. Exercises include sit-to-stand, shoulder press, bicep curl, calf raise, leg extension and lateral arm raise. Throughout the sessions, the exercise conducted, weight lifted during the exercise, sets and repetitions performed and RPE will be recorded (Table 2).

Table 2. Progression plan from week 1 to 12 for the resistance training programme (2 sessions/week).

PhaseWeekIntensityDurationRepetitionsSetsExercise
Phase 1Week 1–2Easy-moderate45 minutes*8–102–3Sit-to-stand, Shoulder press, Bicep curl, Calf raise
Phase 2Week 3–5Easy-hard45–50 minutes*10–123Sit-to-stand, Shoulder press, Bicep curl, Calf raise
Phase 3Week 6–8Moderate-hard60 minutes*123Sit-to-stand, Shoulder press, Bicep curl, Calf raise,
Leg extension, Lateral arm raise
Phase 4Week 9–12Moderate-hard60 minutes*123Sit-to-stand, Shoulder press, Bicep curl, Calf raise,
Leg extension, Lateral arm raise

*Rest period is the same throughout the whole programme: 1–2 minutes between sets; 2–3 minutes between exercises and at least 48 hours between sessions

Data collection

Initial screening data will be collected over the telephone, which will capture home care status, SARC-F score, MNA-short form score, and demographic data. Written informed consent will be obtained at the baseline assessment in the participant’s home (Appendix C)45. Outcome data will be collected at baseline (T1), post-intervention (T2) and 12-weeks post-intervention (T3) in the participant’s home and will be recorded on an online form (Google Forms). If required, assistance with data collection will be provided by the participant’s home carer. Adherence to the ONS will be recorded post-intervention. Adherence to the RT programme will be monitored and recorded throughout the study intervention (T2) (Table 3).

Table 3. Measures at the three study timepoints.

TIMEPOINTT1
Baseline		T2
Post-intervention		T3
12 weeks post-
intervention
ENROLMENT
Eligibility☒
Randomisation☒
Written informed consent☒
OUTCOMES
Timed Up & Go☒☒☒
Mini Nutritional Assessment-Full Form☒☒☒
Body composition☒☒☒
Dietary recall☒☒☒
4-metre gait speed☒☒☒
Handgrip strength☒☒☒
Five times Sit-To-Stand☒☒☒
Cognitive function☒☒☒
Depression risk☒☒☒
Activities of daily living☒☒☒
Quality of life☒☒☒
Number of participants recruited☒
Number of participants retained☒☒
Adherence to oral nutritional supplement☒
Adherence to resistance training ☒
Acceptability of oral nutritional supplement☒
Acceptability of resistance training☒

Study outcomes

Primary outcomes

The primary study outcomes are the mean difference in TUG (seconds) and MNA-FF score between the ONS + RT group and the RT only group after the 12-week intervention, using the validated TUG54 and MNA-FF assessment tools55.

Timed Up and Go

Participants will be timed when asked to stand up from a standardised armchair (46 cm seat height), walk 3 metres, turn around, walk back and sit down54. The use of a walking aid will be permitted. The following reference values will be used: 9.2 (8.2–10.2) seconds for 70 to 79 years, and 11.3 (10–12.7) seconds for 80 to 99 years56. A cut-off time of 20 seconds1 or those unable to complete the TUG due to health problems will be considered low physical function57. The TUG has demonstrated good inter-rater and intra-rater (intraclass correlation coefficient = 0.99) reliability54.

Mini-Nutritional Assessment-Full Form

The MNA-FF will be used to assess the nutritional status of participants. The MNA-FF includes 18 questions to assess an individual’s nutritional status55. The MNA-FF includes anthropometric measures and questions on general health status, dietary habits and self-perceived health and nutrition status58. A score of 24–30 indicates that an individual is normally nourished, 17–23.5 that an individual is at risk for malnutrition, and a score of <17 that the person is malnourished55. The MNA-FF has demonstrated high sensitivity (96%), specificity (98%), and predictive value (97%) in accurately identifying the nutritional status of older adults compared to clinical assessment59.

Secondary outcomes

Body composition

Height will be measured with a stadiometer, with shoes removed. In participants who are unable to stand, height will be estimated by measuring ulna (forearm) length (cm) with reference to predictive equations60. For ulna length, the distance between the olecranon process and the midpoint of the prominent bone of the wrist (styloid process) will be measured with the left arm folded across the chest with the fingers pointing towards the shoulder60,61.

Participants’ body composition [fat (kg/%), muscle (kg/%), and weight (kg) and BMI (kg/m2)] will be assessed using the Tanita MC-780MA (2015, Tanita Corporation, Japan), an 8 electrode multi-frequency segmental body composition analyser62,63.

Calf and mid-upper arm (MUAC) circumferences will be measured. Calf circumference will be measured with a non-elastic measuring tape using the widest part of the calf64. MUAC will be measured using the same tape, at the midpoint between the acromial process of the shoulder and the olecranon process of the elbow with the arm hanging relaxed at the participant’s side65. Measurements will be taken while seated.

Dietary intake

A 24-hour dietary recall using a multiple pass technique will be conducted at each home-based assessment to establish the dietary pattern of each participant. Participants will be asked to recall all foods and drinks consumed in the previous 24 hours, commencing with first intake of food or drink of the day. Any dietary supplement(s) consumed will also be recorded. The list of foods will be repeated back to the participant, and using closed questions, each participant will be asked about foods frequently omitted (e.g., sauces, dressings, beverages, sweeteners, etc.), timing of meals and additional snacks. A detailed description of food consumed (type, brand, weight) will be recorded. The dietary intake data will be reviewed for a third time with the participant to validate the information. The 24-hour dietary recall data will be analysed using NutriticsTM software (version 5.96). Intakes of protein (g) and energy (kilocalorie) will be calculated as g/kgBW and as kilocalorie/kgBW respectively. Changes in macro and micronutrient intakes between all three timepoints will be assessed.

Gait speed

Gait speed will be measured using 4-metre (m) gait speed. A 4-m flat and unobstructed course will be marked out by tape. Participants will be asked to walk at their usual speed. Once the participant’s foot is across the finish line, the time taken to complete the course will be recorded66,67.

Muscle strength

Handgrip strength will be measured as an indicator of upper limb muscle strength using a dynamometer (Jamar hydraulic hand dynamometer)68. Participants will be asked to squeeze the dynamometer handle with force, with the arm at a 90-degree angle in the seated position. Each participant will complete the test three times with each hand to get an average68. The 2019 EWGSOP cut-offs to define low handgrip strength (<27 kg for males and <16 kg for females) will be used1.

The Five times Sit-To-Stand (5xSTS) will be used to assess lower limb muscle strength69. Participants will be asked to stand from the chair five times as quickly as possible and the time taken to complete the assessment will be recorded69. Using the 2019 EWGSOP cut-off, low muscle strength will be defined as >15 seconds1.

Cognitive function, depression risk and activities of daily living

Cognitive function will be measured with the Mini-Mental State Examination (MMSE)49. Cognitive function impairment is defined as a score <24 points and such individuals will be excluded from the study70. The Geriatric Depression Scale (GDS-15) will be used to screen for depression risk71. This scale assigns scores of zero or one to each response, with a score >5 indicating the presence of depression71. The ability of participants to perform ADLs will be assessed using the Katz Index of Independence in ADLs72. This Index assesses six functional activities: bathing, dressing, toileting, transferring, continence and feeding72.

Quality of life

Quality of life will be assessed using the Short Form (SF)-12 × 2®73. This instrument uses twelve questions to assess perceived general health (physical and social function, pain, emotion and mental health)73.

Feasibility of intervention implementation

Recruitment and Retention

Recruitment rate will be defined as the percentage of eligible participants who consent to participate in the research study (total number of participants recruited divided by the total number of people screened for eligibility multiplied by 100). Retention rate will be defined as the percentage of participants who start and go on to complete the study intervention. The number of participants who complete the follow-up assessment (T3) will also be recorded. Reasons for study dropout will be recorded.

Adherence to oral nutritional supplement

Participants will be asked to self-report intake of ONS per day using a paper copy ONS recording sheet that provides instructions on how to consume the ONS. Participants will check two tick boxes to indicate they have consumed two ONS on the day of consumption and tick one box if only one ONS is consumed. If they have not completely consumed a bottle, they will be asked to record this for the specific day. Participants will be asked to retain both used and unused ONS bottles; these will be counted at the end of the intervention. Adequate adherence will be defined as consuming an average of 10 out of 14 (71%) ONS per week over the 12-week intervention74. Reasons for non-adherence will be recorded.

Adherence to resistance training

Adherence during the supervised RT session will be monitored by the Exercise Instructor who will record attendance, number of repetitions, sets, weight used, and the RPE on the study online recording database. Adequate adherence will be defined as successfully participating in 18 out of 24 sessions (>75%)75. Reasons for non-adherence will be recorded.

Acceptability of the oral nutritional supplement

Acceptability of the ONS will be assessed post-intervention with three questions using a 9-point Hedonic scale to evaluate flavour, texture, and overall acceptance76. Additionally, four questions will utilise a 5-point Hedonic scale to assess visual appearance, smell, taste, and aftertaste of the ONS76. Participants will also respond to a final question regarding their willingness to purchase the protein drink, with options ranging from "would certainly buy" to "would certainly not buy"76.

Acceptability of the resistance training programme

A short bespoke questionnaire completed by participants post-intervention will be used to evaluate their perceptions of the RT programme. All questionnaire statements are framed positively, and participants will be asked to rate their agreement with each statement on a five-point Likert scale ranging from “Strongly disagree” to “Strongly agree”. Participants’ responses will be collated and summarised77.

Adverse events

Should an adverse event occur, it will be discussed immediately with the research advisory team (CC, CCu, KH) and participants will be advised to contact their general practitioner as appropriate. As per ethical approval, the occurrence of any unexpected serious adverse event will be reported to the UCD HREC (hrec@ucd.ie).

Data management

Personal data will be stored in a password protected university database in compliance with the Data Protection Act 201878. Only the researchers will have access to this information. Each participant will be assigned a study identification number, which will be used to pseudonymise the data collected. All data will be pseudonymised for analysis, enabling the potential re-linking of individual participant data for data checking if necessary. All data will be anonymised after four years. transferred to Nutricia Ireland Ltd as per the signed legal agreement between UCD and Nutricia Ireland.

Statistical analysis plan

Statistical analyses will be performed using SPSS Statistics for Windows, version 27 (SPSS Inc., Chicago, Ill., USA) and RStudio (2023.06.2. Posit, PBC) as appropriate. Data cleaning will be conducted prior to analysis.

Demographic data and study primary and secondary outcomes will be described using measures such as mean and standard deviation, median and interquartile range, 95% confidence interval, or count and percentage. Descriptive statistics will also be used to report the feasibility of the intervention. Missing data will not be imputed for the primary analysis.

Data will be analysed using the intention-to-treat approach, wherein all participants who have been randomly allocated to the study intervention79 will be included. The primary outcome is the mean difference in the change of TUG (seconds) and MNA-FF scores between the ONS + RT group and the RT only group following the completion of the 12-week intervention. Between-group linear mixed-model analysis will be used to assess the mean difference in change from baseline to post-intervention. The dependent variables will be TUG and MNA-FF with group (ONS + RT, RT), time (baseline, post-intervention), and the group-by-time interaction as fixed factors; participant ID as a random factor; and baseline values as covariates. To establish the minimal clinically important differences for TUG and MNA-FF scores, distribution-based methods will be employed80. The standard deviation of TUG times and MNA-FF scores from pre- and post-intervention measurements will be calculated to assess variability. The effect size (Cohen’s d) will be determined using the mean difference and standard deviation. Residuals will be tested for normality, and transformations will be applied as needed to address non-normal data distribution.

Using the same approach as above, between-group differences and within-group differences at baseline, after, and 12 weeks post-intervention will be analysed for secondary outcomes.

A per-protocol analysis will also be conducted, including participants who adhered to the intervention and have baseline and post-intervention measurements81.

A p-value of less than 0.05 will be considered statistically significant.

Funding

The POWER study is funded by Nutricia Ireland Ltd. The funder will have no role in the study design, conduct, data analysis, interpretation of results or write up of the study findings. A signed legal agreement between UCD and Nutricia Ireland specifies that the purpose of the grant funding is to carry out a study and the funds are to support genuine independent research, advancement of science and education, or patient and public education.

Dissemination of findings

The study results will be disseminated through peer-reviewed journal article(s) and presented at relevant scientific conferences. The study will be disseminated to healthcare professionals such as community nurses, dietitians, gerontologists and physiotherapists as well as to volunteer organisations for older adults. The results of the study will be reported to the funder (Nutricia Ireland Ltd).

Discussion

Interventions to improve the physical function and nutritional status of older adults with sarcopenia risk are needed5,82. The POWER Study aims to evaluate the combined effects of a novel whey protein ONS combined with an online RT programme compared to the RT programme alone on TUG and MNA-FF in community-dwelling older adults at risk of sarcopenia who receive supportive home care.

ONS are commonly prescribed in clinical settings to improve dietary energy and/or protein intake in those unable to take adequate nutrition through food sources alone83. The ONS provided in this study contains whey protein, shown to stimulate muscle protein synthesis in older adults84. It is also enriched with the essential amino acid leucine and vitamin D, both of which have been previously shown to have additional benefits on muscle strength, mass and physical function in older adults34,84. Two servings per day will enable participants to comply with European Society for Clinical Nutrition and Metabolism guidelines for ONS (600 kcal and 40 g protein daily)83.

RT is a safe strategy to increase muscle mass, strength and physical function in older adults with sarcopenia85. Providing RT online can make exercise more accessible to those who lack transport and, if supervised, can improve adherence since participants are monitored86. A recent systematic review and meta-analysis concluded that RT combined with whey protein supplementation in older adults with sarcopenia improved grip strength, increased energy and protein intake and reduced inflammatory markers compared to placebo87. Results also showed that whey protein supplementation had a significant effect on gait speed, ADL scores, and blood biomarkers, including albumin, Insulin-like Growth Factor-1 and 25-hydroxyvitamin D87. However, given that the studies conducted to date varied in type and intensity of RT, protein supplement quantity and length of intervention, the authors advised that more studies should be conducted to validate their findings and further explore the effects of whey protein and RT in patients with sarcopenia87. Furthermore, older adults receiving supportive home care are an often-overlooked cohort in multicomponent interventions88.

This online RT programme, developed with a registered physiotherapist and exercise physiologist, follows the American College of Sports Medicine guidelines89 and sarcopenia RT prescription recommendations18. This intervention will provide a structured, supervised exercise programme, encouraging participants to stay committed, which will aid adherence44. Exercises will be appropriately modified and monitored throughout the intervention. As with other programmes delivered via an online platform, a limitation to this study will be that some older adults will not have access to Zoom (via laptop or tablet), therefore limiting their ability to participate. However, it provides a viable alternative for those unable to access a centre or facility for in-person RT programmes90.

Assessments 12 weeks post-intervention will examine the long-term effects once the intervention ceases. Although participants may show good adherence to the online RT programme, they may discontinue RT once the programme stops91. Therefore, the sustained effects of the interventions on physical function, nutritional status and health-related outcomes will be examined 12 weeks post-intervention.

A limitation of this study includes lack of a placebo supplement; therefore, intervention blinding will not be possible. A specific stipulation by the UCD Ethics Committee, given the vulnerability of the study population, was that dietary advice should be provided to all participants to promote an increase of dietary protein through food sources. Providing dietary advice to all participants may act as a confounding factor, making it challenging to isolate the effects of the ONS from changes due to the dietary advice. In addition, as both groups are undertaking the online RT programme, following a similar design to previous research in a vulnerable population36, the effectiveness of the RT programme alone compared to no exercise is not possible to determine. However, in addition to the primary analysis comparing the outcomes between ONS + RT versus RT alone, the statistical approach will allow for main effects of time to be identified across both groups, which can be interpreted in relation to minimal clinically important differences. Furthermore, collecting biomarkers of muscle protein synthesis or 25-hydroxyvitamin D (25(OH)D) level will not be possible. Older adults who are housebound in Ireland are recommended a daily supplement of 20 µg of vitamin D, due to limited sun exposure and insufficient intake through food33. Hence, participants currently taking vitamin D supplements will not be excluded from the current study.

Conclusion

In summary, the POWER Study will provide data on the effectiveness and feasibility of an ONS combined with a 12-week online RT programme compared to the RT programme alone, in older adults with sarcopenia risk who receive supportive home care. It will also provide information on whether any changes observed following the intervention are maintained, 12 weeks post intervention. This will contribute to knowledge of how these interventions affect physical function and nutritional status and inform future research and practice.

Ethics

Declaration of Helsinki

The study will be conducted in compliance with the Helsinki declaration92.

Approvals

Ethics and consent to participate: The study was submitted for ethical approval to the UCD Human Research Ethics Committee (HREC) on 24 October 2022. Following review and addressing queries, the study was approved (LS-22-59-Corish) on 31 January 2023. The POWER study was registered on ClinicalTrials.gov (NCT05688956) in December 2022. To broaden recruitment within the Irish Health Service Executive (HSE), the study was submitted to and approved by the Clinical Research Ethics Committee Galway (C.A 3058; 6 July 2023) for Community Healthcare Organisation (CHO) area 2 (Co. Galway, Co. Roscommon and Co. Mayo, Ireland) and by the HSE Research Ethics Committee Midlands Area and Corporate (Co. Wicklow, Dun Laoghaire, Dublin South East, Co. Laois, Co. Offaly, Co. Longford, Co. Westmeath, Co. Louth and Co. Meath, Ireland) (RRECB1023CC; on 17 January 2024). Adverse events will be recorded and reported to the UCD and relevant ethics committees.

Written informed consent will be obtained at the baseline assessment in the participant’s home prior to any study related procedures being undertaken. The consent form is available at the UCD Research Data Zenodo Community repository (Appendix C)45.

Declaration of Generative AI and AI-assisted technologies in the writing process

The authors declare that they have not used Generative AI and AI-assisted technologies in the writing process.

Data availability

Underlying data

No data are associated with this article.

Extended data

Zenodo: Protein Supplement and Exercise Training for the Treatment of Sarcopenia Risk in Older Adults (POWER), https://doi.org/10.5281/zenodo.1485693545.

This project contains the following extended data:

  • - SPIRIT checklist

  • - Nutritional content of the ONS

  • - Participant consent form

  • - Study design and participant flow figure

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

Reporting guidelines

UCD Research Data Zenodo Community: This protocol study will be reported following the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) with a summary checklist reported (Appendix A) for ‘Oral nutritional supplement combined with an online resistance training programme to improve physical function and nutritional status in older adults receiving home care and at risk of sarcopenia: protocol for the randomised controlled POWER trial’ https://doi.org/10.5281/zenodo.1485693545.

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

Author roles

Fallon C.M.: Conceptualisation, Data Curation, Investigation, Methodology, Project Administration, Visualisation, Writing – Original Draft Preparation, Writing – Review & Editing

Cunningham C.G.: Conceptualisation, Funding Acquisition, Investigation, Methodology, Resources, Supervision, Visualisation, Writing – Review & Editing

Horner K.: Conceptualisation, Funding Acquisition, Investigation, Methodology, Resources, Supervision, Visualisation, Writing – Review & Editing

Corish C.A.: Conceptualisation, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Supervision, Visualisation, Writing – Review & Editing

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Fallon CM, Cunningham CG, Horner K and Corish CA. Oral nutritional supplement combined with an online resistance training programme to improve physical function and nutritional status in older adults receiving home care and at risk of sarcopenia:  protocol for the randomised controlled POWER trial [version 1; peer review: awaiting peer review]. HRB Open Res 2025, 8:41 (https://doi.org/10.12688/hrbopenres.14086.1)
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