RecruitingNot ApplicableNCT07271082
Efficacy and Safety of Home-based Structured Physical Exercise in Patients With Acute Ischemic Stroke
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)
Sponsor
Capital Medical University
Enrollment
208 participants
Start Date
Dec 18, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- 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.
Exclusion Criteria10
- 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.
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Interventions
BEHAVIORALExercise intervention
Subjects will undergo 90 days of home-based structured physical exercise guidance.
Locations(6)
View Full Details on ClinicalTrials.gov
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NCT07271082
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