Feasibility and Effectiveness of a 12-week Concurrent Exercise Training on Physical Performance, Muscular Strength and Circulating Myokines in Frail Older Adults Living in Nursing Homes: a Cluster Randomized Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Change from Baseline on Short Physical Performance Battery (SPBB)
研究概览
简要总结
The present study is a crossover randomized controlled trial that aims to investigate the effects of concurrent exercise training over usual care on physical performance, muscle strength, and myokines concentrations in frail older adults living in nursing homes.The main questions it aims to answer is: Can a 12-week exercise intervention provide beneficial effects on physical performance, muscle strength and myokines among the most frail participants? Researchers will compare this intervention to usual care. Nursing homes (comprising participants) will be randomly assigned to a sequence of interventions (AB or BA), being A -exercise and B usual care. Participants will be assessed before and after each intervention.
详细描述
The present study is a crossover randomized controlled trial that aims to investigate the effectiveness of a concurrent exercise training over usual care on physical performance, muscle strength, and myokines concentrations in frail older adults living in nursing homes. Nursing homes will be randomly assigned to receive a sequence of interventions (AB or BA), being A -exercise and B usual care. Participants will receive a 12-weeks of either exercise intervention or usual care. A 4-week washout period will be conducted between interventions. Participants will assessed before and after each intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Classified as frail according to the Fried criteria (e.g., frailty phenotype ≥ 3 criteria);
- •Not having participated in any exercise intervention for the last 3 months;
- •Being able to ambulate (with/without assistance).
排除标准
- •Any contraindication that could affect physical exercise performance or testing procedures, including terminal illness, uncontrolled disease or other unstable medical condition;
- •Bone fracture in the past three months;
- •having a short physical performance battery score (SPPB) < 3.
结局指标
主要结局
Change from Baseline on Short Physical Performance Battery (SPBB)
时间窗: Assessment at baseline and immediately after 12 weeks of intervention, in each period.
The Short Physical Performance Battery (SPPB) is a standardised assessment tool of lower limb function, testing 3 dimensions: standing balance, walking speed, and chair stands. Each component is scored between 0-4, total score from 0 (poor performance) to 12 (best performance).
次要结局
- Change from Baseline on circulating levels of myostatin(Change from baseline and 12 weeks in each intervention, in both periods)
- Change from baseline on isokinetic knee strength(Change from baseline and 12 weeks in each intervention, in both periods)
- Change from Baseline on Handgrip test(Assessment at baseline and immediately after 12 weeks of intervention, in each period)
- Change from Baseline on circulating levels of Decorin(Assessment at baseline and immediately after 12 weeks of intervention, in each period)
研究者
Maria Joana Carvalho
Principal Investigator
Universidade do Porto