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Regular physical activity for patients with symptomatic intracranial arterial stenosis

Regular Physical Activity in Patients With Symptomatic Intracranial Arterial Stenosis: a Prospective Randomized Open-label Blinded Endpoint Trial

Phase 3 Interventional Capital Medical University · NCT06615726

This study is testing if regular exercise can help people aged 40 to 80 who have had a recent stroke or mini-stroke avoid having another stroke.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1300 (estimated)
Ages40 Years to 80 Years
SexAll
SponsorCapital Medical University Academic / other
Locations58 sites (Fuyang, Anhui and 57 other locations)
Trial IDNCT06615726 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of regular physical activity in preventing ischemic stroke events among patients with symptomatic intracranial arterial stenosis. It targets individuals aged 40 to 80 who have experienced an ischemic stroke or transient ischemic attack within the last 30 days. Participants will be assigned to either a regular physical activity group or a control group, with outcomes measured to assess the impact on stroke recurrence. The study aims to address the high recurrence rates of stroke in this patient population, particularly in regions with significant incidence rates.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 40 to 80 who have recently experienced an ischemic stroke or TIA attributed to significant intracranial arterial stenosis.

Not a fit: Patients with recent stroke progression, significant pre-existing disability, or concurrent severe medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a non-invasive intervention to significantly reduce the risk of recurrent strokes in patients with symptomatic intracranial arterial stenosis.

How similar studies have performed: Previous studies have indicated that aggressive medical treatment is effective for symptomatic intracranial arterial stenosis, but the role of regular physical activity in this context is less established.

Eligibility criteria

Show full inclusion / exclusion criteria 
1. Inclusion criteria:

1. Age ≥40 years and ≤80 years;
2. Ischemic stroke or TIA (transient ischemic attack) onset ≤30 days;
3. 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 );
4. mRS (modified Rankin Scale)≤4;
5. The patient himself or his legal representative signs the informed consent form.

2. Exclusion criteria:

1. 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).
2. mRS≥1 before the stroke onset.
3. 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.
4. Complicated with motor disorders such as Parkinson\'s disease and Parkinson\'s syndrome.
5. The vessels responsible for this stroke had tandem lesions (more than 50% of extracranial artery stenosis).
6. The vessel responsible for this stroke has undergone intracranial balloon angioplasty and/or stent implantation (except for mechanical thrombectomy and/or aspiration alone).
7. 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.
8. 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.
9. Inability to understand and/or comply with the trial procedures and/or follow-up due to mental illness, cognitive or emotional disorders.
10. Life expectancy is less than one year.
11. Women who are known to be pregnant or nursing, or have a positive pregnancy test;
12. Are participating in other drug or device research.
13. There are other circumstances that investigators consider are not suitable for enrollment.

Where this trial is running

Fuyang, Anhui and 57 other locations

+8 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ischemic StrokeTransient Ischemic AttackIschemic strokeSymptomatic intracranial arterial stenosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.