Protein Supplement and Exercise Training for the Treatment of Malnutrition and Sarcopenia Risk in Older Adults

Study Overview
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Brief Summary
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To explore the efficacy 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 homecare and are at risk of both malnutrition and sarcopenia.

Detailed Description
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The aim of this study is to investigate the efficacy of consuming a whey protein oral nutritional supplement (ONS) enriched with leucine and vitamin D, in conjunction with a resistance-based exercise programme delivered using telehealth, versus the efficacy of the exercise programme alone, for twelve weeks, in a cohort of older adults who are at risk of both malnutrition and sarcopenia and who require supportive homecare. The primary outcome will be nutritional status measured using 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 function as well as quality of life. 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 groups will be as follows: (i) whey protein ONS enriched with leucine and vitamin D plus an exercise programme delivered using telehealth or (ii) exercise programme delivered using telehealth. Participants allocated to the ONS group will be provided with the ONS, and the exercise programme will be delivered using the UCD Zoom platform. To ensure that the PhD researcher can safely manage the study participants, there will be a staggered start. Two groups (a) ONS + exercise programme and (b) exercise programme alone will begin the intervention within one month of screening, complete the 12-week intervention and be reassessed after a further 12 weeks. The other two groups (c) ONS + exercise programme and (d) exercise programme alone will be assessed at week 0 and will begin the intervention 12 to 16 weeks later. Nutritional status will be reassessed to determine if any changes to nutritional status have occurred between screening and commencing the intervention. The staggered start group will then begin the intervention and complete the intervention after twelve weeks.

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

Conditions
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Sarcopenia, Malnutrition

Intervention / Treatment
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* Dietary Supplement: Fortimel Advanced, Nutricia
* Other: Resistance Exercise programme
* Other: Dietary advice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older adults (70+ years) Requiring supportive homecare At risk of malnutrition (MNA-SF) At risk of sarcopenia (EWGSOP2) 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

Ages Eligible for Study
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Minimum Age: 70 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: (i) ONS + Exercise group<br>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<br>* Per 200 mL serving size: 300 kcal, 21 g whey protein, 3 g leucine & 10 µg Vitamin D.<br>Other: Resistance Exercise programme<br>* 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.<br>Other: Dietary advice<br>* 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.<br>|
| Active Comparator: (ii) Exercise-alone group<br>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<br>* 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.<br>Other: Dietary advice<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Nutritional Status at 12 weeks | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment | The number of participants recruited at the end of the study | 24 weeks | 
| Retention | The number of participants retained at the end of the study | 24 weeks | 
| 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 | 12 weeks | 
| Muscle strength | Handgrip strength will be used to assess upper-body strength | 12 weeks | 
| Five Times Sit-To-Stand test | Five Times Sit-To-Stand test will be used to assess lower extremity strength | 12 weeks | 
| Timed Get Up & Go test | Timed Get Up & Go test will be used to assess physical performance advised by the advised by the EWGSOP2 to test for sarcopenia | 12 weeks | 
| 4 m Gait Speed test | 4 m Gait Speed test will be used to assess physical performance advised by the advised by the EWGSOP2 to test for sarcopenia | 12 weeks | 
| Change in self-reported quality of life | The Health Related Quality of Life 12-Item Short Form Survey (SF-12) will be used to assess participants quality of life. Score ranges from 0 - 100, higher score indicates higher quality of life. | 12 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. | 12 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Older adults, Homecare, Community-dwelling, Malnutrition, Sarcopenia, Oral Nutritional Supplement, Resistance exercise