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

Capital Medical University

Status

Enrolling

Conditions

Ischemic Stroke

Transient Ischemic Attack

Treatments

Other: Non-Interventional Study

Study type

Observational

Funder types

Other

Identifiers

NCT07242768

SPORTS1102

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,300 estimated patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

1,300 participants in 2 patient groups

Regular Physical Exercise Group

Description:

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

Treatment:

Other: Non-Interventional Study

Control Group

Description:

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

Treatment:

Other: Non-Interventional Study