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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
208
Subjects will undergo 90 days of home-based structured physical exercise guidance.
Taihe Hospital of Traditional Chinese Medicine
Fuyang, Anhui, China
Suzhou Municipal Hospital
Suzhou, Anhui, China
Beijing Pinggu District Hospital
Beijing, Beijing Municipality, China
Xihua County People's Hospital
Zhoukou, Henan, China
Change in 6-Minute Walk Test Distance
Time frame: Between baseline and 90 days
Proportion of patients with mRS score 0-1
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
Time frame: 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.
Time frame: 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.
Time frame: 90 days and 1year
Mean daily step count
Time frame: 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.
Time frame: 90 days and 1year
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.
Time frame: 90 days
Resting heart rate
Time frame: 90 days
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Shihezi People's Hospital
Shihezi, Xinjiang, China
Xuanwu Hospital, Capital Medical University, 100053
Beijing, China
Resting blood pressure
Time frame: 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.
Time frame: 90 days and 1year