Efficacy and Safety of Home-based Structured Physical Exercise in Patients With Acute Ischemic Stroke: a Randomized Controlled, Open-label, Blinded Endpoint Trial-2 (HOPE-STROKE 2)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 208
- 试验地点
- 8
- 主要终点
- Change in 6-Minute Walk Test Distance
研究概览
简要总结
This study is a randomized controlled, open-label, blinded endpoint trial. The investigators aim to assess the efficacy and safety of home-based structured physical exercise in participants with acute ischemic stroke.
详细描述
The study population is participants with acute ischemic stroke within 14 days of onset. All participants are randomly assigned to the exercise intervention group or the control group in a 1:1 ratio. In the exercise intervention group, participants will undergo 90 days of home-based structured physical exercise guidance. The individualized exercise prescription will be determined based on each participant's overall condition. In the control group, participants will not receive structured physical exercise guidance but are encouraged to engage in regular physical exercise. Both groups of participants will receive standard medical management based on the latest guidelines from the American Heart Association/American Stroke Association.
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
- 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
- •Age 18 years or greater, male or female;
- •Acute ischemic stroke onset within 14 days;
- •modified Rankin scale (mRS) score ≤ 3;
- •Signed informed consent from the patients or the legally authorized representatives.
排除标准
- •Stroke progression within the past 3 days (defined as an increase in NIHSS score of ≥4 points or an increase in any single item of ≥2 points);
- •Concurrent osteoarthritis, fractures, deep vein thrombosis, unstable angina, severe heart diseases, respiratory diseases, or amputation that may theoretically make it difficult for participants to complete the physical exercise or ambulation;
- •Concurrent movement disorders such as Parkinson's disease or Parkinsonism;
- •Patients who have engaged in regular aerobic physical activity within the past 6 months, defined as more than 150 minutes of moderate-intensity aerobic physical activity; or more than 75 minutes of vigorous-intensity aerobic physical activity; or an equivalent combination of moderate- and vigorous-intensity activity throughout the week;
- •Unable to comply with the study procedures or follow-up due to psychiatric, cognitive, or emotional disorders;
- •Known pregnancy or lactation, or a positive pregnancy test;
- •Currently participating in another drug or device study;
- •Life expectancy less than 1 year;
- •Unable to communicate using a smartphone;
- •Other conditions considered by investigators to be unsuitable for inclusion.
研究组 & 干预措施
Control group
Subjects will not receive structured physical exercise guidance but are encouraged to engage in regular physical exercise.
Exercise intervention group
Home-based structured physical exercise guidance.
干预措施: Exercise intervention (Behavioral)
结局指标
主要结局
Change in 6-Minute Walk Test Distance
时间窗: Between baseline and 90 days
次要结局
- Proportion of patients with mRS score 0-1(90 days and 1year)
- Physical Activity Scale for the Elderly (PASE) score(90 days and 1year)
- Short Physical Performance Battery (SPPB) score(90 days and 1year)
- Mean daily step count(90 days and 1year)
- Patient Health Questionnaire-9 (PHQ-9) score(90 days and 1year)
- EQ-5D-5L and EQ-VAS(90 days and 1year)
- Proportion of patients with mRS score 0-1(90 days)
- Physical Activity Scale for the Elderly (PASE) score(90 days)
- Short Physical Performance Battery (SPPB) score(90 days)
- Mean daily step count(90 days)
- Patient Health Questionnaire-9 (PHQ-9) score(90 days)
- Mini Montreal Cognitive Assessment score(90 days)
- Resting heart rate(90 days)
- Resting blood pressure(90 days)
- EQ-5D-5L and EQ-VAS(90 days)
研究者
Ji Xunming,MD,PhD
Professor of Neurology, Xuanwu Hospital, Capital Medical University
Capital Medical University