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To explore the effectiveness of a 12-week resistance exercise programme plus or minus an oral nutritional supplement on the nutritional status of community-dwelling older adults who receive home care and are at risk of sarcopenia.
The aim of this study is to investigate the effectiveness of consuming a whey-based protein ONS enriched with leucine and vitamin D, in conjunction with an online resistance-based exercise programme, versus the effectiveness of an online exercise programme alone, for twelve weeks, in a cohort of older adults who are at risk of sarcopenia and who require supportive home care.
The primary outcome will be functional and nutritional status measured using the Timed get Up and Go (TUG) test and the full form of the mini-nutritional assessment (MNA-FF). The secondary outcomes include feasibility of implementation, defined by recruitment, retention and adherence rates, measures of body composition, muscle strength and quality of life.
The groups will be as follows: (i) whey protein ONS enriched with leucine and vitamin D plus an online exercise programme or (ii) an online exercise programme alone.
The exercise programme will be comprised of two sessions per week for 12-weeks and will be delivered using the UCD Zoom platform. The exercise programme will include strength movements that are intended to build muscle mass and improve physical function. The exercise programme will involve four phases split over the 12-week intervention: phase 1 (2 weeks), phase 2 (3 weeks), phase 3 (3 weeks) and phase 4 (4 weeks).
The ONS is a high protein, leucine and vitamin D enriched drink. Participants randomised to the ONS group will be asked to consume the drink twice a day for 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (i) ONS + Exercise group | Experimental | This group will consume whey protein ONS enriched with leucine and vitamin D, twice a day for 12 weeks. The optimal time to consume the ONS on non-exercise days will be based on each participants 24-hour dietary recall. On exercise days, participants will be asked to consume the ONS after breakfast and after the exercise class. Participants will participate in a resistance-based exercise programme twice a week for 12 weeks which will be carried out over Zoom. Standard dietary advice to increase intake of protein, leucine and vitamin D using available literature designed for those at risk of malnutrition will be provided to this group by the research nutritionist. |
|
| (ii) Exercise-alone group | Active Comparator | Participants will participate in a resistance-based exercise programme twice a week for 12 weeks which will be carried out over Zoom. Standard dietary advice to increase intake of protein, leucine and vitamin D using available literature designed for those at risk of malnutrition will be provided to this group by the research nutritionist. The participants will not be provided with a placebo ONS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fortimel Advanced, Nutricia | Dietary Supplement | Per 200 mL serving size: 300 kcal, 21 g whey protein, 3 g leucine & 10 µg Vitamin D. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline functional status at 12 weeks | Timed Get Up & Go test will be used to assess physical performance as advised by the EWGSOP2 to test for sarcopenia. | 12 weeks |
| Change from baseline nutritional status at 12 weeks | The nutritional status of participants will be assessed using the full form of the mini-nutritional assessment-full form (MNA-FF). 24 - 30 points indicates normal nutrition status; 17 to 23.5 points indicates at risk of malnutrition & less than 17 points indicates malnutrition. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence | Attendance at the resistance exercise classes + consumption of the protein supplement | 12 weeks |
| Muscle mass | Muscle mass will be assessed using Bioelectrical Impedance Analysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCD School of Public Health, Physiotherapy and Sports Science | Dublin | Leinster | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41467085 | Derived | Fallon CM, Cunningham CG, Horner K, 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. HRB Open Res. 2026 Jan 20;8:41. doi: 10.12688/hrbopenres.14086.3. eCollection 2025. |
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There is not a plan to make IPD available.
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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A randomised, parallel group, 12-week clinical trial with two groups of older adults aged 70+ years requiring supportive home care will be undertaken.
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Participants will be randomly assigned to either consume the oral nutritional supplement or not.
Each participant will know if they are either taking the oral nutritional supplement or not. There is no placebo, ONS being provided. Standard dietary advice to increase intake of protein, leucine and vitamin D using available literature designed for those at risk of malnutrition will be provided to both groups.
| Resistance Exercise programme | Other | Participants will participate in the resistance-based exercise programme twice a week for 12-weeks via Zoom. Each session will last between 45-60 minutes with 2-3 sets and 8-12 reps, twice a week for the 12 weeks. |
|
| Dietary advice | Other | Standard dietary advice to increase intake of protein, leucine and vitamin D using available literature designed for those at risk of malnutrition will be provided to both groups by the research nutritionist. Literature provided will include booklets containing lists of foods high in protein, leucine and vitamin D plus easy-to-prepare meal ideas. The dietary advice provided will be informed by the 24-hour dietary recall information obtained from each participant. |
|
| Values at baseline will be compared to values recorded at 12 and at 24 weeks |
| Muscle strength | Handgrip strength will be used to assess upper-body strength | Values at baseline will be compared to values recorded at 12 and at 24 weeks |
| Five Times Sit-To-Stand test | Five Times Sit-To-Stand test will be used to assess lower extremity strength | Values at baseline will be compared to values recorded at 12 and at 24 weeks |
| 4 m Gait Speed test | 4 m Gait Speed test will be used to assess physical performance as advised by the EWGSOP2 to test for sarcopenia | Values at baseline will be compared to values recorded at 12 and at 24 weeks |
| Change in self-reported quality of life | The Health Related Quality of Life 12-Item Short Form Survey (SF-12v2) will be used to assess participants quality of life. Score ranges from 0 - 100, higher score indicates higher quality of life. | Values at baseline will be compared to values recorded at 12 and at 24 weeks |
| Change in risk of depression | The Geriatric Depression Score-15 item questionnaire will be used to screen for risk of depression in the participants. Score of 0-5 is normal & score greater than 5 suggests risk of depression. | Values at baseline will be compared to values recorded at 12 and at 24 weeks |
| Change in functional status | The Katz Index of Independence in Activities of Daily Living will be used to assess functional status. Score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment. | Values at baseline will be compared to values recorded at 12 and at 24 weeks |
| Change in baseline nutritional status at week 24 | The nutritional status of participants will assessed using the full form of the mini-nutritional assessment-full form (MNA-FF). 24 - 30 points indicates normal nutrition status, 17 to 23.5 points indicates at risk of malnutrition & less than 17 points indicates malnutrition. | 24 weeks |
| Change from baseline functional status at 24 weeks | Timed Get Up & Go test will be used to assess physical performance as advised by the EWGSOP2 to test for sarcopenia. | 24 weeks |
| Retention | The number of participants retained at the end of the study | Up to 24 weeks |
| Recruitment | The number of participants recruited divided by the number of eligible participants. | Up to 24 weeks |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |