Home-based structured exercise for people with recent 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)

This program will test if a 90-day, home-based structured exercise plan helps people who had an acute ischemic stroke within the past 14 days.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 208 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Capital Medical University (Academic / other)
• Locations: 6 sites (Fuyang, Anhui and 5 other locations)
• Trial ID: NCT07271082 on ClinicalTrials.gov

What this trial studies

This randomized, open-label, blinded-endpoint trial enrolls adults with acute ischemic stroke within 14 days of onset and randomizes them 1:1 to an exercise intervention or control group. The intervention group receives individualized, home-based structured physical exercise guidance for 90 days while the control group receives usual care and encouragement to exercise without structured guidance. All participants continue standard medical management per American Heart Association/American Stroke Association guidelines, and outcomes are assessed by blinded evaluators. The exercise prescription is tailored to each participant's overall condition with safety monitoring to track adverse events.

Who should consider this trial

Good fit: Adults aged 18 years or older with an acute ischemic stroke onset within 14 days, a modified Rankin Scale score of 0–3, and ability to provide informed consent are ideal candidates.

Not a fit: Patients with recent stroke progression, major cardiac/respiratory/orthopedic limitations, movement disorders like Parkinsonism, or those who already engage in regular aerobic exercise are unlikely to benefit from this program.

Why it matters

Potential benefit: If successful, the program could improve functional recovery and reduce disability after acute ischemic stroke.

How similar studies have performed: Earlier stroke rehabilitation and exercise studies show benefits for recovery, but specifically structured, home-based programs initiated in the acute phase have been less extensively tested.

Eligibility criteria

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.

Where this trial is running

Fuyang, Anhui and 5 other locations

• Taihe Hospital of Traditional Chinese Medicine — Fuyang, Anhui, China (Recruiting)
• Suzhou Municipal Hospital — Suzhou, Anhui, China (Recruiting)
• Beijing Pinggu District Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Xihua County People's Hospital — Zhoukou, Henan, China (Recruiting)
• Shihezi People's Hospital — Shihezi, Xinjiang, China (Recruiting)
• Xuanwu Hospital, Capital Medical University, 100053 — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Xunming Ji, PhD/MD

Conditions Acute Ischemic Stroke; Physical Exercise