Trials / Completed
CompletedNCT05688956
Protein Supplement and Exercise Training for the Treatment of Sarcopenia Risk in Older Adults
Protein Supplement and Exercise Training for the Treatment of Sarcopenia Risk in Older Adults Who Receive Supportive Home Care: POWER Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- University College Dublin · Academic / Other
- Sex
- All
- Age
- 70 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Fortimel Advanced, Nutricia | Per 200 mL serving size: 300 kcal, 21 g whey protein, 3 g leucine \& 10 µg Vitamin D. |
| OTHER | Resistance Exercise programme | 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. |
| OTHER | Dietary advice | 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. |
Timeline
- Start date
- 2023-02-01
- Primary completion
- 2025-05-31
- Completion
- 2025-05-31
- First posted
- 2023-01-18
- Last updated
- 2026-03-17
Locations
1 site across 1 country: Ireland
Source: ClinicalTrials.gov record NCT05688956. Inclusion in this directory is not an endorsement.