Protein Supplement and Exercise Training for the Treatment of Sarcopenia Risk in Older Adults (POWER)

Protein Supplement and Exercise Training for the Treatment of Sarcopenia Risk in Older Adults Who Receive Supportive Home Care: POWER Study

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.

Study Overview

• Status: Completed
• Conditions: Sarcopenia
• Intervention / Treatment: Dietary supplement: Fortimel Advanced, Nutricia; Other: Resistance Exercise programme; Other: Dietary advice

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Leinster
    • Dublin, Leinster, Ireland
      • UCD School of Public Health, Physiotherapy and Sports Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years to 100 years (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Older adults (70+ years)
• Requiring supportive homecare
• At risk of sarcopenia

Exclusion Criteria:

• Cognitive impairment
• Severe kidney disease (glomerular filtration rate < 30 mL/min)
• Moderate to severe liver disease (Child-Pugh class B or C)
• Psychiatric disorder
• Receiving treatment or palliative care for cancer
• Receiving enteral or parenteral nutrition
• Hypersensitivity to any component of ONS
• Taking ONS
• Allergic to dairy products
• Regularly undertaking resistance (strength) training
• Advised by GP not to undertake physical activity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: (i) ONS + Exercise group; 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.	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.
Active Comparator: (ii) Exercise-alone group; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence	Attendance at the resistance exercise classes + consumption of the protein supplement	12 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
Muscle mass	Muscle mass will be assessed using Bioelectrical Impedance Analysis	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 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

Collaborators and Investigators

• Sponsor: University College Dublin

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): May 31, 2025
• Study Completion (Actual): May 31, 2025

Study Registration Dates

• First Submitted: December 14, 2022
• First Submitted That Met QC Criteria: January 14, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Sarcopenia; Older adults; Resistance exercise; Home care; Community-dwelling; Oral Nutritional Supplement
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sarcopenia; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Epidemiologic Measurements; Nutrition Assessment
• Other Study ID Numbers: 107102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No