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

Regular Physical Exercise in Patients With Symptomatic Intracranial Arterial Stenosis: Three-year Follow-up of RESIST Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke; Transient Ischemic Attack
• Intervention / Treatment: Other: Non-Interventional Study

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 Type: Observational
• Enrollment (Estimated): 1300

Contacts and Locations

• Study Contact: Name: Xunming Ji; Phone Number: 01083198962; Email: jixm@ccmu.edu.cn
• Study Contact Backup: Name: Chuanjie Wu; Phone Number: 01083199439; Email: wuchuanjie@ccmu.edu.cn

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Xuanwu Hospital, Capital Medical University
    • Contact: Chuanjie Wu; Phone Number: 01083199439; Email: wuchuanjie@ccmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will include the subjects who enrolled in the RESIST trial.

Description

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.

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Non-Interventional Study; 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.	Other: Non-Interventional Study; After completing 12-month intervention from RESIST trial, investigators would not make any interventions or impact on subjects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
New ischemic stroke events	Within 3 years after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The modified Rankin scale (range, 0 [no symptoms] to 6 [death], with higher scores indicating greater disability)	At 3 years after randomization
The score of mini-Montreal Cognitive Assessment	The score of mini-Montreal Cognitive Assessment (range, 0 to 15, with higher scores indicating greater cognition)	At 3 years after randomization
Quality of life assessed by EuroQol 5 Dimensions 5 level questionnaire (EQ-5D-5L)	The EQ-5D-5L includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= n	At 3 years after randomization
All-cause death		Within 3 years after randomization
Rate of Falls		Within 3 years after randomization

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Ischemic Stroke; Transient Ischemic Attack; Symptomatic intracranial arterial stenosis
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Stroke; Ischemic Stroke; Ischemic Attack, Transient
• Other Study ID Numbers: SPORTS1102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study is proceeding.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No