Efficacy and Safety of Home-based Structured Physical Exercise in Patients With Acute Ischemic Stroke (HOPE-STROKE 2)

Capital Medical University

Status: Enrolling

Conditions: Acute Ischemic Stroke

Treatments: Behavioral: Exercise intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07271082

HOPE-STROKE 2

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 208 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 years or greater, male or female;
2. Acute ischemic stroke onset within 14 days;
3. modified Rankin scale (mRS) score ≤ 3;
4. Signed informed consent from the patients or the legally authorized representatives.

Exclusion criteria

1. 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);
2. 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;
3. Concurrent movement disorders such as Parkinson's disease or Parkinsonism;
4. 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;
5. Unable to comply with the study procedures or follow-up due to psychiatric, cognitive, or emotional disorders;
6. Known pregnancy or lactation, or a positive pregnancy test;
7. Currently participating in another drug or device study;
8. Life expectancy less than 1 year;
9. Unable to communicate using a smartphone;
10. Other conditions considered by investigators to be unsuitable for inclusion.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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208 participants in 2 patient groups

Exercise intervention group

Experimental group

Description:

Home-based structured physical exercise guidance.

Treatment:

Behavioral: Exercise intervention

Control group

No Intervention group

Description:

Subjects will not receive structured physical exercise guidance but are encouraged to engage in regular physical exercise.