Power Exercise for Stroke Recovery: The POWER Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Feasibility: Participant recruitment
研究概览
简要总结
Post-stroke deficits are highly common and functional impairment persists throughout life after stroke. Skeletal muscle mass and strength are fundamental contributors to mobility throughout the adult life course. Stroke-related muscle atrophy contributes to loss of strength, and declines in lower extremity function, cardiorespiratory fitness, and walking independence and post-stroke sarcopenia. Improving the quantity and function of skeletal muscle needs to be an important therapeutic target after stroke. Resistance exercise training (RET) has been shown to increase skeletal muscle mass, strength and power, reduce oxidative stress, improve cardiac function, and better regulate lipids after stroke. However, the feasibility and the effects of a power focused RET program for individuals with stroke need to be examined.
详细描述
This study is a single-group, open label trial examining the feasibility and preliminary effect estimates of a 10-week power-focused exercise training program in people living with stroke. Fifteen participants with chronic stroke will participate in the exercise program 3 times per week for 10 weeks at a progressive intensity. The program will take place at a community exercise gym built for older adults and people with physical disabilities. Feasibility outcomes will be assessed throughout the trial. Effectiveness outcomes will be assessed at baseline and immediately post-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •≥18 years old
- •≥6 months post-stroke
- •Able to walk >10 meters with or without the use of an assistive device
- •Living in the community
- •Mild to moderate stroke severity (modified Rankin Scale ≤3)
排除标准
- •Any contraindications to exercise for people with cardiovascular disease, such as unstable angina, uncontrolled hypertension, orthostatic blood pressure with exercise, or uncontrolled arrhythmias
- •Significant cognitive impairment that would preclude safe exercise participation (Montreal Cognitive Assessment score <26)
- •Actively engaged in stroke rehabilitation services
结局指标
主要结局
Feasibility: Participant recruitment
时间窗: Through study completion, over 13 months
Recruitment rates (n/week) and the number of recruited subjects (n) will be reported. Criteria for success include recruitment of ≥1 participant per month and n=15 recruited in ≤13 months.
Feasibility: Serious and non-serious adverse events
时间窗: Through study completion, over 13 months
Number of adverse events (i.e., deaths, serious and non-serious adverse events, n) will be reported. Criteria for success is 0 deaths or serious adverse events and \<5 non-serious adverse events.
Feasibility: Sex and gender distribution
时间窗: Through study completion, over 13 months
Recruitment of males and females, men, women and gender diverse participants will be recorded (n, %). Criteria for success is \<60% (n\<9) of any sex or gender identity.
Feasibility: Attendance and attrition
时间窗: Through study completion, over 13 months
Percentage of sessions attended (%) and lost to follow-up (n) will be reported. Criteria for success includes ≥85% sessions attended and ≤10% (n\<2) lost to follow-up.
Feasibility: Exercise tolerance
时间窗: Through study completion, over 13 months
Adherence to the prescribed exercises (%) and abnormal blood pressure responses to exercise (n) will be recorded. Criteria for success includes ≥85 of participants performing ≥85% of sets at the prescribed intensity, and ≤25% of weeks experiencing ≥1 abnormal blood pressure response (SBP ≥210 or ≥190 for males and females, respectively).
Feasibility: Satisfaction
时间窗: Immediately post-intervention (week 10)
Satisfaction will be measured with a 5-point Likert scale (1 = not at all satisfied, 2 = not satisfied, 3 = neither satisfied or not satisfied, 4 = satisfied, and 5 = completely satisfied). Criteria for success is ≥85% of participants reporting being satisfied or completely satisfied with the program.
次要结局
- Timed up and go test(Baseline (week 0) and post-intervention (week 10))
- Short physical performance battery(Baseline (week 0) and post-intervention (week 10))
- 30-second chair stand test(Baseline (week 0) and post-intervention (week 10))
- Isokinetic torque(Baseline (week 0) and post-intervention (week 10))
- Isokinetic power(Baseline (week 0) and post-intervention (week 10))
- Global physical activity questionnaire(Baseline (week 0) and post-intervention (week 10))
- Isometric strength(Baseline (week 0) and post-intervention (week 10))
- Stroke-Impact Scale (SIS-3.0)(Baseline (week 0) and post-intervention (week 10))
研究者
Ada Tang
Associate Professor
McMaster University