Acute Ischemic Stroke
Conditions
Keywords
Acute Ischemic Stroke, Physical Exercise
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.
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.
Interventions
BEHAVIORALExercise intervention
Subjects will undergo 90 days of home-based structured physical exercise guidance.
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in 6-Minute Walk Test Distance | Between baseline and 90 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with mRS score 0-1 | 90 days and 1year | The mRS ranges from 0 to 6, with higher scores indicating worse outcomes. |
| Physical Activity Scale for the Elderly (PASE) score | 90 days and 1year | 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. |
| Short Physical Performance Battery (SPPB) score | 90 days and 1year | This test measures levels of lower extremity function. The SPPB ranges from 0 to 12, with higher scores indicating better outcomes. |
| Mean daily step count | 90 days and 1year | — |
| Patient Health Questionnaire-9 (PHQ-9) score | 90 days and 1year | This test screens for depression. The PHQ-9 ranges from 0 to 27, with higher scores indicating worse outcomes. |
| Mini Montreal Cognitive Assessment score | 90 days | This test measures levels of cognitive function. This test ranges from 0 to 15, with higher scores indicating better outcomes. |
| Resting heart rate | 90 days | — |
| Resting blood pressure | 90 days | — |
| EQ-5D-5L and EQ-VAS | 90 days and 1year | 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. |
Countries
China
Outcome results
None listed