Home-Based RESIST: Rationale and Design of a Multicenter Randomized Controlled Trial.

BACKGROUND: Despite aggressive medical management, patients with symptomatic intracranial artery stenosis (sICAS) have a markedly elevated risk of recurrent stroke. Regular physical exercise is associated with a reduced risk of stroke recurrence. However, the superiority of physical exercise plus usual care over usual care for sICAS in terms of effectiveness and safety still lacks evidence. Moreover, gym-based physical exercise has multiple constraints, making it suboptimal for sustaining lifelong self-directed physical exercise required after stroke. METHODS: This study was conducted to determine the effectiveness and safety of home-based structured physical exercise plus usual care versus usual care in reducing stroke recurrence in patients with sICAS. The RESIST (Structured Physical Exercise for Symptomatic Intracranial Atherosclerotic Stenosis) trial is a multicenter, prospective, randomized, controlled, open-label, blinded end point assessment trial conducted in China. A total of 1300 patients with recent sICAS will be recruited from multiple study centers. Participants will be randomly assigned in a 1:1 ratio to receive home-based structured physical exercise plus usual care or usual care. The primary outcome is new ischemic stroke within 1 year. Secondary outcomes assessed at 1 year include any ischemic stroke or transient ischemic attack in the qualifying artery territory, any ischemic stroke or transient ischemic attack, hemorrhagic stroke, myocardial infarction, the rate of modified Rankin scale 0 to 1, the EuroQoL 5-Dimensions 5-Level, and the mini Montreal Cognitive Assessment. Safety outcomes include fall rate and all-cause mortality. CONCLUSIONS: The RESIST trial will provide crucial evidence on the potential benefits of home-based, structured physical exercise for preventing stroke recurrence in patients with sICAS. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT06615726.