Clinical trial NCT05688956: Protein Supplement and Exercise Training for the Treatment of Sarcopenia Risk in Older Adults
Official title: Protein Supplement and Exercise Training for the Treatment of Sarcopenia Risk in Older Adults Who Receive Supportive Home Care: POWER Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sarcopenia
Keywords: Older adults
Home care
Community-dwelling
Sarcopenia
Oral Nutritional Supplement
Resistance exercise
Lead sponsor: University College Dublin
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 40
Sex: ALL
Minimum age (years): 70
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomised, parallel group, 12-week clinical trial with two groups of older adults aged 70+ years requiring supportive home care will be undertaken.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline functional status at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline nutritional status at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Adherence
timeFrame: 12 weeks
measure: Muscle mass
timeFrame: Values at baseline will be compared to values recorded at 12 and at 24 weeks
measure: Muscle strength
timeFrame: Values at baseline will be compared to values recorded at 12 and at 24 weeks
measure: Five Times Sit-To-Stand test
timeFrame: Values at baseline will be compared to values recorded at 12 and at 24 weeks
measure: 4 m Gait Speed test
timeFrame: Values at baseline will be compared to values recorded at 12 and at 24 weeks
measure: Change in self-reported quality of life
timeFrame: Values at baseline will be compared to values recorded at 12 and at 24 weeks
measure: Change in risk of depression
timeFrame: Values at baseline will be compared to values recorded at 12 and at 24 weeks
measure: Change in functional status
timeFrame: Values at baseline will be compared to values recorded at 12 and at 24 weeks
measure: Change in baseline nutritional status at week 24
timeFrame: 24 weeks
measure: Change from baseline functional status at 24 weeks
timeFrame: 24 weeks
measure: Retention
timeFrame: Up to 24 weeks
measure: Recruitment
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: UCD School of Public Health, Physiotherapy and Sports Science
state: Leinster
Study officials:
References: