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

NCT07271082 | Recruiting DMC

• 1 other identifier: HOPE-STROKE 2
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Acute Ischemic Stroke

Keywords

Acute Ischemic Stroke; Physical Exercise

Outcome Measures

Primary Outcomes (1)

• Change in 6-Minute Walk Test Distance

  Between baseline and 90 days

Secondary Outcomes (9)

• 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

Other Outcomes (2)

• Rate of Falls

  Within 90 days after randomization

• All-cause death

  Within 90 days after randomization

Study Arms (2)

Exercise intervention group

EXPERIMENTAL

Home-based structured physical exercise guidance.

Behavioral: Exercise intervention

Control group

NO INTERVENTION

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

Interventions

Exercise intervention BEHAVIORAL

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

Exercise intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (6)

Taihe Hospital of Traditional Chinese Medicine

Fuyang, Anhui, China

RECRUITING

Suzhou Municipal Hospital

Suzhou, Anhui, 234000, 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, 836800, China

RECRUITING

Xuanwu Hospital, Capital Medical University, 100053

Beijing, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Motor Activity

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Central Study Contacts

Xunming Ji, PhD/MD

CONTACT

01083198962; jixm@ccmu.edu.cn

Chuanjie Wu, MD

CONTACT

01083199439; wuchuanjie@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology, Xuanwu Hospital, Capital Medical University

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 8, 2025
• Study Start: December 18, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (6)