Follow-up Extension Study of Regular Physical Exercise in Patients With Symptomatic Intracranial Arterial Stenosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-10

Study Completion Date

2028-11-30

Brief Summary

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This study will include the subjects with symptomatic intracranial arterial stenosis (ICAS) who have participated in and completed the 1-year follow-up of RESIST trial (NCT06615726). The aim is to observe the long-term clinical outcomes over 3 years after a 1-year regular physical exercise intervention in patients with symptomatic ICAS.

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Detailed Description

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This is a non-interventional, observational study designed to investigate long-term clinical outcomes in symptomatic ICAS patients who have already enrolled in RESIST trial and completed the 1-year follow-up.

After completing 12-month randomized intervention from RESISR trial, investigators continue to follow the subjects up to 3 years without any further intervention or changes to routine clinical management. The primary endpoint is the incidence of new ischemic stroke within 3 years. Secondary endpoints include new ischemic stroke and transient ischemic attack events in the responsible vessel supply area within 3 years; new ischemic stroke and transient ischemic attack events within 3 years; hemorrhagic stroke event within 3 years; myocardial infarction within 3 years; falls within 3 years; all-cause death within 3 years; the proportion of patients with modified Rankin Scale score 0-1 at 3 years; the score of mini-Montreal Cognitive Assessment at 3 years; and the score of EuroQol 5-Dimension 5-Level at 3 years.

Approximately 1,300 subjects who have completed the RESIST trial's 1-year follow-up and consented to continue will be included. The overall study duration will extend from the first participant's entry into the observation period until the last participant completes the 3-year follow-up.

Conditions

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Ischemic Stroke Transient Ischemic Attack

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Regular Physical Exercise Group

Participants with symptomatic ICAS who were assigned to the regular physical exercise intervention in the RESIST trial and completed the 12-month follow-up.

Non-Interventional Study

Intervention Type OTHER

After completing 12-month intervention from RESIST trial, investigators would not make any interventions or impact on subjects.

Control Group

Participants with symptomatic ICAS who were assigned to the control group in the RESIST trial and completed the 12-month follow-up.

Non-Interventional Study

Intervention Type OTHER

After completing 12-month intervention from RESIST trial, investigators would not make any interventions or impact on subjects.

Interventions

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Non-Interventional Study

After completing 12-month intervention from RESIST trial, investigators would not make any interventions or impact on subjects.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Participants who enrolled in the RESIST trial and completed the 12-month follow-up.
2. Written informed consent to participate in this 3-year observational extension.