NCT06870149招募中不适用
Does Cognitive Groove (Brought to You by GERAS DANCE) Improve Physical Performance in Community-Dwelling Older Adults With Frailty: A Parallel Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Change in Physical Performance
研究概览
简要总结
The goal of this clinical trial is to determine the effect of a community-based rehabilitation intervention (Cognitive Groove, Brought to you by GERAS DANCE), compared to usual care, on clinical outcomes in community-dwelling older adults living with frailty. The main questions it aims to answer are:
- In community-dwelling older adults living with frailty, is Cognitive Groove more effective than usual care in improving functional movement, physical performance and strength?
- In community-dwelling older adults living with frailty is Cognitive Groove more effective than usual care in improving frailty status, fear of falling, balance confidence, mood, cognition, grip strength, activities of daily living, life space mobility, loneliness, and quality of life?
- As a community-based rehabilitation intervention, is Cognitive Groove a cost-effective intervention embedded within the community for older adults living with frailty after 12-months?
Participants will participate in Cognitive Groove classes twice per week for 3 months or receive no intervention (usual care).
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Community-dwelling aged ≥65 years
- •At high risk for mobility disability/functional limitations as assessed by the FRAIL Scale ≥2
- •Able to ambulate independently (25 m) with or without an assistive device
- •Able to follow two-step instructions
- •Medical clearance from referring clinician, or for self-referrals, medical clearance from family physician to safely participate in exercise
- •Can arrange transportation to the YMCA up to 2 times per week
排除标准
- •Unable to speak or understand English
- •Current regular participation in a structured exercise program or receiving active physical therapy services
- •Severe cardiac or pulmonary disease
- •Unstable angina or heart failure
- •Severe osteoarthritis (e.g., awaiting joint replacement)
- •Parkinson's disease or other progressive neurological disorder
- •Receiving palliative care
- •Travel/commitments requiring missing more than two weeks
结局指标
主要结局
Change in Physical Performance
时间窗: Baseline and 3-months
Physical function will be assessed with the Short Performance Physical Battery \[total score\]. Higher scores indicate better physical performance \[range 0-12\].
次要结局
- Change in Walking Speed(Baseline to 3-months)
- Change in Functional Mobility(Baseline and 3-months)
- Change in Dual Task Ability(Baseline and 3-months)
- Change in Static Postural Control(Baseline and 3-months)
- Change in Hand Grip Strength(Baseline and 3-months)
- Change in Cognition(Baseline and 3-months)
- Change in Frailty(Baseline and 3-months)
- Change in Fear of Falling(Baseline and 3-months)
- Change in Balance Confidence(Baseline and 3-months)
- Change in Depression/Mood(Baseline and 3-months)
- Change in Loneliness(Baseline and 3-months)
- Change in Basic Activities of Daily Living(Baseline and 3-months)
- Change in Instrumental Activities of Daily Living(Baseline and 3-months)
- Change in Life Space Mobility(Baseline and 3-months)
- Change in Health-related Quality of Life(Baseline, 3-months, and 12-months)
- Change in Healthcare Utilization(Baseline, 3-months, and 12-months)
- Change in Falls(Baseline to 3-months)
- Change in Falls-Related Injuries(Baseline to 3-months)
- Change in Mobility(Baseline to 3-months)
- Adherence(Baseline to 3-months)
- Change in Balance Confidence(Baseline and 3-months)
- Change in Depression/Mood(Baseline and 3-months)
- Change in Loneliness(Baseline and 3-months)
- Change in Basic Activities of Daily Living(Baseline and 3-months)
- Change in Instrumental Activities of Daily Living(Baseline and 3-months)
- Change in Life Space Mobility(Baseline and 3-months)
- Change in Health-related Quality of Life(Baseline, 3-months, and 12-months)
- Change in Walking Speed(Baseline to 3-months)
- Change in Functional Mobility(Baseline and 3-months)
- Change in Dual Task Ability(Baseline and 3-months)
- Change in Static Postural Control(Baseline and 3-months)
- Change in Hand Grip Strength(Baseline and 3-months)
- Change in Cognition(Baseline and 3-months)
- Change in Frailty(Baseline and 3-months)
- Change in Fear of Falling(Baseline and 3-months)
- Change in Healthcare Utilization(Baseline, 3-months, and 12-months)
- Change in Falls(Baseline to 3-months)
- Change in Falls-Related Injuries(Baseline to 3-months)
- Change in Mobility(Baseline to 3-months)
- Adherence(Baseline to 3-months)
研究者
Alexandra Papaioannou
Professor, Department of Medicine
McMaster University
研究点 (2)
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