Protein Supplement and Exercise Training for the Treatment of Sarcopenia Risk in Older Adults Who Receive Supportive Home Care: POWER Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change from baseline functional status at 12 weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will be randomly assigned to either consume the oral nutritional supplement or not.
Each participant will know if they are either taking the oral nutritional supplement or not. There is no placebo, ONS being provided. 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.
入排标准
- 年龄范围
- 70 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older adults (70+ years)
- •Requiring supportive homecare
- •At risk of sarcopenia
排除标准
- •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
研究组 & 干预措施
(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.
干预措施: Fortimel Advanced, Nutricia (Dietary Supplement)
(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.
干预措施: Resistance Exercise programme (Other)
(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.
干预措施: Dietary advice (Other)
(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.
干预措施: Resistance Exercise programme (Other)
(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.
干预措施: Dietary advice (Other)
结局指标
主要结局
Change from baseline functional status at 12 weeks
时间窗: 12 weeks
Timed Get Up \& Go test will be used to assess physical performance as advised by the EWGSOP2 to test for sarcopenia.
Change from baseline nutritional status at 12 weeks
时间窗: 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.
次要结局
- Adherence(12 weeks)
- Muscle mass(Values at baseline will be compared to values recorded at 12 and at 24 weeks)
- Muscle strength(Values at baseline will be compared to values recorded at 12 and at 24 weeks)
- Five Times Sit-To-Stand test(Values at baseline will be compared to values recorded at 12 and at 24 weeks)
- 4 m Gait Speed test(Values at baseline will be compared to values recorded at 12 and at 24 weeks)
- Change in self-reported quality of life(Values at baseline will be compared to values recorded at 12 and at 24 weeks)
- Change in risk of depression(Values at baseline will be compared to values recorded at 12 and at 24 weeks)
- Change in functional status(Values at baseline will be compared to values recorded at 12 and at 24 weeks)
- Recruitment(Up to 24 weeks)
- Change in baseline nutritional status at week 24(24 weeks)
- Change from baseline functional status at 24 weeks(24 weeks)
- Retention(Up to 24 weeks)