Power Exercise for Stroke Recovery: A Pilot Randomized Controlled Trial (POWER-Pilot)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Feasibility: Randomization - Percentage of participants allocated as assigned
研究概览
简要总结
Weakness is one of the most common consequences of stroke. For the over 750,000 Canadians living with stroke, many daily activities like standing from a chair, walking and balance not only require strength but often efforts in bursts, known as muscle power. Strength training can improve muscle strength and, when performed at higher speeds, can help build muscle power. Current guidelines for stroke recommend strength training but these are commonly performed at lower intensities and do not include any focus on building muscle power. There has been very little research on power training after stroke.
A 10-week power training program for people living with stroke, Power Exercise for Stroke Recovery (POWER-Feasibility, NCT05816811) was recently evaluated. POWER includes 3 phases of progressive exercise: building familiarity with the upper and lower body exercises, then strength, and lastly muscle power. The results from POWER-Feasibility are promising, suggesting that POWER is safe and may improve stroke recovery. POWER-Feasibility was a small study (15 participants), and POWER was not compared to a control intervention.
A pilot randomized controlled trial of POWER (POWER-Pilot) will now be conducted. Sixty people who are at least 6 months after stroke will be recruited. They will be randomly assigned to participate in POWER or standard strength training for stroke at lower intensities and without focus on power training. The feasibility of a randomized study will be examined, and whether POWER can improve walking, strength and balance compared to the control group. Results from POWER-Pilot will help design a larger randomized trial in the future (POWER-RCT), and may ultimately be important for stroke rehabilitation teams to better understand whether power training can help people recovering from stroke.
详细描述
With the population aging, nearly 750,000 Canadians live with stroke, surpassing previous projections by 15 years. Post-stroke deficits, including loss of strength, balance and walking ability, are highly common. Sarcopenia, often associated with aging yet highly prevalent in stroke, underlie these deficits and contribute to lower discharge rates after hospitalization.
Community stroke exercise programs can improve strength and function to aid in recovery beyond hospital care. Most programs however follow conservative resistance exercise training (RET) approaches, as stroke guidelines are based on limited evidence. Unlike benefits of RET shown in mobility in older adults, stroke trials have shown large improvements in strength without concurrent changes in mobility, motor function or walking.
Power-focused RET involves moving lighter weights at high speed to develop muscle power, which may be more important than strength alone for activities critical for independent living such as climbing stairs, balance, and walking speed. A novel, progressive power training-focused community program for stroke (Power Exercise for Stroke Recovery, POWER) was developed to influence recovery of physical function. Following a successful single-group feasibility study of POWER (POWER-Feasibility, NCT05816811), a phase II pilot randomized trial (POWER-Pilot) is needed.
This pilot randomized trial aims to answer the following questions: 1) What is the feasibility of a multi-site randomized design to evaluate Power Exercise for Stroke Recovery (POWER), a power-focused training program for people living in the community with stroke? 2) What are the preliminary estimates of the effect of POWER compared to conventionally recommended RET (Strength Training Engaging Guidelines to Enhance Total Health, STRENGTH) for people living in the community with stroke on outcomes of functional mobility (walking, balance), post-stroke fatigue, psychological wellbeing, cognition, and health-related quality of life?
Sixty participants (6 months post-stroke, completed rehabilitation) will be randomized to POWER or STRENGTH. POWER involves 3 progressive phases: 1) Familiarization (1 week), 2) Strength (4 weeks, 2-3 sets, 5-8 repetitions), and 3) Power (5 weeks, 2-3 sets, 15-20 repetitions, fast tempo). STRENGTH is based on current RET clinical practice guidelines for stroke with no focus on power. POWER and STRENGTH matched in length, frequency (3x/week) and format (in-person supervision) but differentiated by approach to exercise progression, intensity, and tempo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥19 years old
- •≥6 months poststroke,
- •able to walk >10 meters with or without an assistive device
- •have mild to moderate stroke severity (modified Rankin Scale ≤3)
- •without significant cognitive impairment that would preclude safe exercise, screened via Montreal Cognitive Assessment-Blind score <18
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 or
- •Actively engaged in or have made plans to engage in stroke rehabilitation services
结局指标
主要结局
Feasibility: Randomization - Percentage of participants allocated as assigned
时间窗: Through study completion, over 24 months
Indicator: Yes/No; Criteria for success and progression: Success: 100% participants allocated as assigned, Revise: \<100% participants allocated as assigned
Feasibility: Randomization - Clinically important difference between groups
时间窗: Through study completion, over 24 months
Indicator: Balance of prognosis; Criteria for success and progression: Success: No clinically important differences between groups, Revise: Clinically important differences between groups
Feasibility: Allocation concealment
时间窗: Through study completion, over 24 months
Indicator: Yes/No; Criteria for success and progression: Success: Allocation concealment preserved, Revise: Allocation revealed
Feasibility: Assessor blinding - Number of occurrences of unblinding
时间窗: Through study completion, over 24 months
Indicator: # occurrences of unblinding; Criteria for success and progression: Success: Assessors unblinded for \<5% of participants, Revise: Assessors unblinded for ≥5% of participants
Feasibility: Contamination - Number of participants exposed to other intervention arm
时间窗: Through study completion, over 24 months
Indicator: # participants exposed to the other intervention arm; Criteria for success and progression: Success: No occurrences of contamination, Revise: Any occurrence of contamination
Feasibility: Recruitment rate - Number of participants recruited per month
时间窗: Through study completion, over 24 months
Indicator: # recruited / month; Criteria for success and progression: Success: Mean 1.0 participants/month/site, Revise: Mean \<1.0 participants/month/site
Feasibility: Retention rate - Percentage of participants with follow up data
时间窗: Through study completion, over 24 months
Indicator: % follow up data; Criteria for success and progression: Success: Complete follow up data in ≥80% participants, Revise: Complete follow up data in \<80% participants
Feasibility: Participant and assessor burden - Percentage of participants completing study assessments in ≤1.5h
时间窗: Through study completion, over 24 months
Indicator: time to complete assessments; Criteria for success and progression: Success: ≥80% complete assessments in ≤1.5h, Revise: \<80% complete assessments in ≤1.5h
Feasibility: Participant and assessor burden - Participant rating of the burden of assessments
时间窗: Through study completion, over 24 months
Indicator: perceived burden of assessments; Criteria for success and progression: Success: Rating ≤3 on 10-point Likert scale (1=not at all; 10=extremely burdensome), Revise: Rating \>3 out of 10
Feasibility: Safety - Number of serious adverse events
时间窗: Through study completion, over 24 months
Indicator: Serious adverse events from assessments or interventions; Criteria for success and progression: Success: 0 occurrences, Revise: Any occurrences
Feasibility: Treatment effect - Availability of clinical outcome data
时间窗: Through study completion, over 24 months
Indicator: Number of available data points at post-intervention; Criteria for success and progression: ≥90% (n=54/60) data available on all clinical outcomes of interest
Functional mobility: Timed Up and Go (TUG) test (self- and fast-paced)
时间窗: Baseline (0 weeks), post-intervention (10 weeks), follow-up (18 weeks)
The Timed Up and Go is a measure of functional mobility. A standard chair (\~46cm in height) will be placed at the start of a flat walking course and a cone will be placed 3 meters from the chair. Participants will stand from the chair, walk 3 meters, turn back towards the chair, and sit back down, without assistance. This will be completed at a comfortable pace and fast pace. The task will be timed and measured in seconds, a shorter time indicates better mobility and balance.
次要结局
- Health-related quality of life: Stroke Impact Scale 3.0 (SIS 3.0)(Baseline (0 weeks), post-intervention (10 weeks), follow-up (18 weeks))
- Health-related quality of life: EuroQol-5D-5L (EQ-5D-5L)(Baseline (0 weeks), post-intervention (10 weeks), follow-up (18 weeks))
- Participation: Measure of Experiential Aspects of Participation (MeEAP)(Baseline (0 weeks), post-intervention (10 weeks), follow-up (18 weeks))
- Lower extremity strength and endurance: 30-second chair stand test (30sCST)(Baseline (0 weeks), post-intervention (10 weeks), follow-up (18 weeks))
- Self-efficacy for balance: Activities-Specific Balance Confidence Scale (ABC)(Baseline (0 weeks), post-intervention (10 weeks), follow-up (18 weeks))
- Confidence in exercising: Exercise Self-Efficacy Scale (ESES)(Baseline (0 weeks), post-intervention (10 weeks), follow-up (18 weeks))
- Responsiveness to outcome measures: Global Rating of Change (GRC) questionnaire(Post-intervention (10 weeks))
- Health-related quality of life: Stroke Impact Scale 3.0 (SIS 3.0)(Baseline (0 weeks), post-intervention (10 weeks), follow-up (18 weeks))
- Health-related quality of life: EuroQol-5D-5L (EQ-5D-5L)(Baseline (0 weeks), post-intervention (10 weeks), follow-up (18 weeks))
- Participation: Measure of Experiential Aspects of Participation (MeEAP)(Baseline (0 weeks), post-intervention (10 weeks), follow-up (18 weeks))
- Lower extremity strength and endurance: 30-second chair stand test (30sCST)(Baseline (0 weeks), post-intervention (10 weeks), follow-up (18 weeks))
- Self-efficacy for balance: Activities-Specific Balance Confidence Scale (ABC)(Baseline (0 weeks), post-intervention (10 weeks), follow-up (18 weeks))
- Confidence in exercising: Exercise Self-Efficacy Scale (ESES)(Baseline (0 weeks), post-intervention (10 weeks), follow-up (18 weeks))
- Responsiveness to outcome measures: Global Rating of Change (GRC) questionnaire(Post-intervention (10 weeks))
- Walking speed: 10-meter walking speed (self- and fast-paced)(Baseline (0 weeks), post-intervention (10 weeks), follow-up (18 weeks))
- Post-stroke fatigue: Fatigue Severity Scale-7 (FFS)(Baseline (0 weeks), post-intervention (10 weeks), follow-up (18 weeks))
- Psychological well-being: General Health Questionnaire-28(Baseline (0 weeks), post-intervention (10 weeks), follow-up (18 weeks))
- Cognition: Montreal Cognitive Assessment (MoCA)(Baseline (0 weeks), post-intervention (10 weeks), follow-up (18 weeks))
- Standing balance: Brief Balance Evaluation System Test (Brief BESTest)(Baseline (0 weeks), post-intervention (10 weeks), follow-up (18 weeks))
- Standing balance: Berg Balance Scale (BBS)(Baseline (0 weeks), post-intervention (10 weeks), follow-up (18 weeks))
研究者
Ada Tang
Professor, Assistant Dean
McMaster University