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

May 16, 2026 updated by: Ji Xunming,MD,PhD, Capital Medical University

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 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

208

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Xuanwu Hospital, Capital Medical University, 100053
    • Anhui
      • Fuyang, Anhui, China
        • Taihe Hospital of Traditional Chinese Medicine
      • Suzhou, Anhui, China, 234000
        • Suzhou Municipal Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Beijing Pinggu District Hospital
    • Henan
      • Zhoukou, Henan, China
        • Xihua County People's Hospital
    • Xinjiang
      • Shihezi, Xinjiang, China, 836800
        • Shihezi People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise intervention group
Home-based structured physical exercise guidance.
Behavioral: Exercise intervention
Subjects will undergo 90 days of home-based structured physical exercise guidance.
No Intervention: Control group
Subjects will not receive structured physical exercise guidance but are encouraged to engage in regular physical exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in 6-Minute Walk Test Distance
Time Frame: Between baseline and 90 days
Between baseline and 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with mRS score 0-1
Time Frame: 90 days
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
90 days
Physical Activity Scale for the Elderly (PASE) score
Time Frame: 90 days
This test assesses physical activity, including leisure, household, and occupational activity. Score range: minimum 0 to maximum 400 or more. Higher score means a better outcome.
90 days
Short Physical Performance Battery (SPPB) score
Time Frame: 90 days
This test measures levels of lower extremity function. The SPPB ranges from 0 to 12, with higher scores indicating better outcomes.
90 days
Mean daily step count
Time Frame: 90 days
90 days
Patient Health Questionnaire-9 (PHQ-9) score
Time Frame: 90 days
This test screens for depression. The PHQ-9 ranges from 0 to 27, with higher scores indicating worse outcomes.
90 days
Mini Montreal Cognitive Assessment score
Time Frame: 90 days
This test measures levels of cognitive function. This test ranges from 0 to 15, with higher scores indicating better outcomes.
90 days
Resting heart rate
Time Frame: 90 days
90 days
Resting blood pressure
Time Frame: 90 days
90 days
EQ-5D-5L and EQ-VAS
Time Frame: 90 days
The EQ-5D-5L includes 5 dimensions: mobility, self-care, usual activities,pain/discomfort, and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Higher scores indicate worse quality of life.
90 days

Other Outcome Measures

Outcome Measure
Time Frame
Rate of Falls
Time Frame: Within 90 days after randomization
Within 90 days after randomization
All-cause death
Time Frame: Within 90 days after randomization
Within 90 days after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

November 27, 2025

First Submitted That Met QC Criteria

November 27, 2025

First Posted (Actual)

December 8, 2025

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 16, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOPE-STROKE 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Related data will be shared if full study protocol and statistical analysis plan are provided with reasonable design.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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