Regular Physical Exercise in Patients With Symptomatic Intracranial Arterial Stenosis: Three-year Follow-up of RESIST Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,300
- Locations
- 1
- Primary Endpoint
- New ischemic stroke events
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants who enrolled in the RESIST trial and completed the 12-month follow-up.
- •Written informed consent to participate in this 3-year observational extension.
Exclusion Criteria
- •Participants who withdrew consent in the RESIST trial, decline to participate in this extension, or were lost to follow-up at 12 months.
Arms & Interventions
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.
Intervention: Non-Interventional Study (Other)
Control Group
Participants with symptomatic ICAS who were assigned to the control group in the RESIST trial and completed the 12-month follow-up.
Intervention: Non-Interventional Study (Other)
Outcomes
Primary Outcomes
New ischemic stroke events
Time Frame: Within 3 years after randomization
Secondary Outcomes
- New ischemic stroke and transient ischemic attack events in the responsible vessel supply area(Within 3 years after randomization)
- New ischemic stroke and transient ischemic attack events(Within 3 years after randomization)
- Hemorrhagic stroke events(Within 3 years after randomization)
- Myocardial infarction events(Within 3 years after randomization)
- Proportion of patients achieving modified Rankin Scale score (mRS) 0-1(At 3 years after randomization)
- The score of mini-Montreal Cognitive Assessment(At 3 years after randomization)
- Quality of life assessed by EuroQol 5 Dimensions 5 level questionnaire (EQ-5D-5L)(At 3 years after randomization)
- Rate of Falls(Within 3 years after randomization)
- All-cause death(Within 3 years after randomization)
Investigators
Ji Xunming,MD,PhD
Professor of Neurology, Xuanwu Hospital, Capital Medical University
Capital Medical University