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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Per 200 mL serving size: 300 kcal, 21 g whey protein, 3 g leucine \& 10 µg Vitamin D.
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.
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.
UCD School of Public Health, Physiotherapy and Sports Science
Dublin, Leinster, Ireland
RECRUITINGChange 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.
Time frame: 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.
Time frame: 12 weeks
Adherence
Attendance at the resistance exercise classes + consumption of the protein supplement
Time frame: 12 weeks
Muscle mass
Muscle mass will be assessed using Bioelectrical Impedance Analysis
Time frame: 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
Time frame: 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
Time frame: 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
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 weeks
Retention
The number of participants retained at the end of the study
Time frame: Up to 24 weeks
Recruitment
The number of participants recruited divided by the number of eligible participants.
Time frame: Up to 24 weeks