Regular Physical Exercise in Patients With Symptomatic Intracranial Arterial Stenosis (NCT06615726) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Regular Physical Exercise in Patients With Symptomatic Intracranial Arterial Stenosis
China1,300 participantsStarted 2024-10-10
Plain-language summary
The objective of this study is to evaluate the effectiveness and safety of regular physical exercise in preventing ischemic stroke events in patients with symptomatic intracranial arterial stenosis.
Who can participate
Age range40 Years – 80 Years
SexALL
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Inclusion criteria
✓. Age ≥40 years and ≤80 years;
✓. Ischemic stroke or TIA (transient ischemic attack) onset ≤30 days;
✓. Ischemic stroke or TIA is attributed to 50-99% of the ICAS (internal carotid artery, M1 segment of middle cerebral artery, M2 segment of middle cerebral artery, basilar artery, or vertebral artery; the degree of stenosis is determined by magnetic resonance angiography, computed tomography angiography, digital subtraction angiography using the standards of warfarin-aspirin symptomatic intracranial disease );
✓. mRS (modified Rankin Scale)≤4;
✓. The patient himself or his legal representative signs the informed consent form.
Exclusion criteria
✕. Stroke progression within the past 3 days (defined as an increase in the score of National Institute of Health Stroke Scale ≥4 points or an increase in individual items of ≥2 points).
✕. mRS≥1 before the stroke onset.
✕. Concurrent osteoarthritis, fracture, lower limb venous thrombosis, unstable angina pectoris, respiratory diseases, limb disabilities, etc., making it theoretically difficult to cooperate with the physical activity plan for this trial.
✕. Complicated with motor disorders such as Parkinson\'s disease and Parkinson\'s syndrome.
✕. The vessels responsible for this stroke had tandem lesions (more than 50% of extracranial artery stenosis).
. The vessel responsible for this stroke has undergone intracranial balloon angioplasty and/or stent implantation (except for mechanical thrombectomy and/or aspiration alone).
✕. It is expected that intracranial arterial balloon angioplasty and/or stent implantation will be performed on the vessel responsible for the stroke within 3 months.
✕. Patients who exercised regularly within the last 6 months. Regular exercise is defined as four or more moderate intensity exercises per week for more than 10 minutes each time or two or more high intensity exercises per week for more than 10 minutes each time.