Efficacy and Safety of Home-based Structured Physical Exercise in Patients With Acute Ischemic Stroke

NCT ID: NCT07271082

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-18

Study Completion Date

2026-09-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Ischemic Stroke

Keywords

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Acute Ischemic Stroke Physical Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Exercise intervention group

Home-based structured physical exercise guidance.

Group Type EXPERIMENTAL

Exercise intervention

Intervention Type BEHAVIORAL

Subjects will undergo 90 days of home-based structured physical exercise guidance.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise intervention

Subjects will undergo 90 days of home-based structured physical exercise guidance.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Ji Xunming,MD,PhD

Professor of Neurology, Xuanwu Hospital, Capital Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Taihe Hospital of Traditional Chinese Medicine

Fuyang, Anhui, China

Site Status RECRUITING

Suzhou Municipal Hospital

Suzhou, Anhui, China

Site Status RECRUITING

Beijing Pinggu District Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Xihua County People's Hospital

Zhoukou, Henan, China

Site Status RECRUITING

Shihezi People's Hospital

Shihezi, Xinjiang, China

Site Status RECRUITING

Xuanwu Hospital, Capital Medical University, 100053

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xunming Ji, PhD/MD

Role: CONTACT

Phone: 01083198962

Email: [email protected]

Chuanjie Wu, MD

Role: CONTACT

Phone: 01083199439

Email: [email protected]

Facility Contacts

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Zongtao Liu

Role: primary

Zhengfei Ma

Role: primary

Yifei Chen

Role: primary

Chaoqun Li

Role: primary

Dekun Zhu

Role: primary

Chuanjie Wu, MD

Role: primary

Xunming Ji, MD

Role: backup

Other Identifiers

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HOPE-STROKE 2

Identifier Type: -

Identifier Source: org_study_id