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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise intervention group | Experimental | Home-based structured physical exercise guidance. |
|
| Control group | No Intervention | Subjects will not receive structured physical exercise guidance but are encouraged to engage in regular physical exercise. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise intervention | Behavioral | Subjects will undergo 90 days of home-based structured physical exercise guidance. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in 6-Minute Walk Test Distance | Between baseline and 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with mRS score 0-1 | The mRS ranges from 0 to 6, with higher scores indicating worse outcomes. | 90 days |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Falls | Within 90 days after randomization | |
| All-cause death | Within 90 days after randomization |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taihe Hospital of Traditional Chinese Medicine | Fuyang | Anhui | China | |||
| Suzhou Municipal Hospital |
Related data will be shared if full study protocol and statistical analysis plan are provided with reasonable design.
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 90 days |
| 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 |
| Mean daily step count | 90 days |
| 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 |
| 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 |
| 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 |
| Suzhou |
| Anhui |
| 234000 |
| China |
| Beijing Pinggu District Hospital | Beijing | Beijing Municipality | China |
| Xihua County People's Hospital | Zhoukou | Henan | China |
| Shihezi People's Hospital | Shihezi | Xinjiang | 836800 | China |
| Xuanwu Hospital, Capital Medical University, 100053 | Beijing | China |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |