Follow-up Extension Study of Regular Physical Exercise in Patients With Symptomatic Intracranial Arterial Stenosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-Interventional Study.
- Who it may be relevant to
- Registry conditions: Ischemic Stroke, Transient Ischemic Attack. Basic parameters: 40 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Regular Physical Exercise in Patients With Symptomatic Intracranial Arterial Stenosis: Three-year Follow-up of RESIST Trial
Overview
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.
Interventions
- Other Non-Interventional Study
After completing 12-month intervention from RESIST trial, investigators would not make any interventions or impact on subjects.
Primary outcome measures
- New ischemic stroke events [Time frame: Within 3 years after randomization]
Secondary outcome measures (9)
- New ischemic stroke and transient ischemic attack events in the responsible vessel supply area [Time frame: Within 3 years after randomization]
- New ischemic stroke and transient ischemic attack events [Time frame: Within 3 years after randomization]
- Hemorrhagic stroke events [Time frame: Within 3 years after randomization]
- Myocardial infarction events [Time frame: Within 3 years after randomization]
- Proportion of patients achieving modified Rankin Scale score (mRS) 0-1 [Time frame: At 3 years after randomization]
- The score of mini-Montreal Cognitive Assessment [Time frame: At 3 years after randomization]
- Quality of life assessed by EuroQol 5 Dimensions 5 level questionnaire (EQ-5D-5L) [Time frame: At 3 years after randomization]
- Rate of Falls [Time frame: Within 3 years after randomization]
- All-cause death [Time frame: Within 3 years after randomization]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Xuanwu Hospital, Capital Medical University — Beijing
Identifiers
NCT: NCT07242768 · SPORTS1102