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

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: Acute Ischemic Stroke
• Intervention / Treatment: Behavioral: Exercise intervention

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 (Actual): 208
• Phase: Not Applicable

Contacts and Locations

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Between baseline and 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mini Montreal Cognitive Assessment score	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		90 days
Resting blood pressure		90 days
Proportion of patients with mRS score 0-1	The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.	90 days and 1year
Physical Activity Scale for the Elderly (PASE) score	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 and 1year
Short Physical Performance Battery (SPPB) score	This test measures levels of lower extremity function. The SPPB ranges from 0 to 12, with higher scores indicating better outcomes.	90 days and 1year
Mean daily step count		90 days and 1year
Patient Health Questionnaire-9 (PHQ-9) score	This test screens for depression. The PHQ-9 ranges from 0 to 27, with higher scores indicating worse outcomes.	90 days and 1year
EQ-5D-5L and EQ-VAS	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 and 1year

Other Outcome Measures

Outcome Measure	Time Frame
Rate of Falls	Within 90 days and 1year after randomization
All-cause death	Within 90 days and 1year after randomization
Change in 6-Minute Walk Test Distance	Between baseline and 1 year

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2025
• Primary Completion (Actual): August 14, 2026
• Study Completion (Estimated): August 14, 2027

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): September 14, 2026
• Last Update Submitted That Met QC Criteria: September 10, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Physical Exercise; Acute Ischemic Stroke
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Behavior; Ischemic Stroke; Motor Activity
• 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