Fit For Function: A Community Wellness Program for Persons With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 218
- 试验地点
- 5
- 主要终点
- Change in the Reintegration to Normal Living Index (RNL) from baseline
研究概览
简要总结
Building on an earlier pilot study, this randomized controlled trial will compare the effectiveness of a 12 week community YMCA-based wellness program specifically designed for people with stroke (Fit for Function) to a standard YMCA membership.
详细描述
The program will be delivered through a partnership between McMaster University, the YMCA and Hamilton Health Sciences/ the Brant Community Healthcare System/ the Niagara Health System. Participants will exercise three times a week and receive weekly education about how to take care of themselves after a stroke. The YMCA staff who deliver the program will have specialized training about how to help people with a stroke exercise safely and effectively. The hospital within each region will provide specialized on-site physiotherapy consultative support. The comparator standard YMCA membership will include typical sessions with a wellness coach who has basic safety training regarding stroke and exercise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with stroke
- •18 years of age or older
- •community dwelling
- •able to walk 10m independently, with or without an assistive device
- •medically approved by a physician to participate
- •able to tolerate 60 minutes of activity with rest intervals
- •able to independently follow instructions
排除标准
- •involved in an active rehabilitation program
研究组 & 干预措施
Fit For Function Program
A 12-week YMCA-based wellness program for persons with stroke, consisting of 2 group exercise sessions, one gym exercise session and one education session per week with trained instructors.
干预措施: Fit For Function Program (Other)
Standard YMCA membership
A 12 week standard YMCA membership.
干预措施: Standard YMCA membership (Other)
结局指标
主要结局
Change in the Reintegration to Normal Living Index (RNL) from baseline
时间窗: baseline, 12 weeks, 24 weeks
This measure assesses the degree to which individuals who have experienced traumatic or incapacitating illness achieve reintegration into normal social activities.
次要结局
- Change in The Rapid Assessment of Physical Activity (RAPA) score from baseline(baseline, 12 weeks, 24 weeks)
- Change in blood glucose levels from baseline(baseline, 12 weeks, 24 weeks)
- Change in The Short Portable Performance Tests (SPPT) score from baseline(baseline, 12 weeks, 24 weeks)
- Change in The Six Minute Walk Test (6MWT) from baseline(baseline, 12 weeks, 24 weeks)
- Change in Strength: Grip and Knee extension from baseline(baseline, 12 weeks, 24 weeks)
- Change in The EQ-5D score from baseline(baseline, 12 weeks, 24 weeks)
- Change in The Patient Activation Measure (PAM) score from baseline(baseline, 12 weeks, 24 weeks)
- Change in blood inflammatory markers from baseline(baseline, 12 weeks, 24 weeks)
- Change in The Body Mass Index (BMI) score from baseline(baseline, 12 weeks, 24 weeks)
- Change in Blood lipid levels from baseline(baseline, 12 weeks, 24 weeks)
- Healthcare Utilization Questionnaire(0- 24 weeks)