Regular Physical Exercise in Patients With Symptomatic Intracranial Arterial Stenosis
RESIST
1 other identifier
interventional
1,300
1 country
58
Brief Summary
The objective of this study is to evaluate the effectiveness and safety of regular physical exercise in preventing ischemic stroke events in patients with symptomatic intracranial arterial stenosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2024
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2024
CompletedFirst Posted
Study publicly available on registry
September 27, 2024
CompletedStudy Start
First participant enrolled
October 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 19, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 19, 2026
November 25, 2025
November 1, 2025
2.1 years
September 24, 2024
November 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
New ischemic stroke events
1 year
Secondary Outcomes (7)
New ischemic stroke and transient ischemic attack events in the responsible vessel supply area
1 year
New ischemic stroke and transient ischemic attack events
1 year
Hemorrhagic stroke event
1 year
Myocardial infarction
1 year
The proportion of modified Rankin Scale score 0-1 (range, 0 to 6, with higher scores indicating greater disability)
1 year
- +2 more secondary outcomes
Other Outcomes (2)
Falls
1 year
All-cause death
1 year
Study Arms (2)
regular physical exercise group
EXPERIMENTALControl group
OTHERInterventions
Best medical treatment plus regular physical exercise. Each subject is equipped with an exercise guidance expert to regularly guide and adjust the exercise plan according to the subject's personal conditions throughout the trial period. After randomization, the exercise guidance expert formulated an individualized aerobic exercise plan based on the subject's preferences and their own exercise abilities. After each exercise, subjects filled out the exercise diary , and reported back to the exercise guidance expert.
Eligibility Criteria
You may qualify if:
- Age ≥40 years and ≤80 years;
- Ischemic stroke or TIA (transient ischemic attack) onset ≤30 days;
- Ischemic stroke or TIA is attributed to 50-99% of the ICAS (internal carotid artery, M1 segment of middle cerebral artery, M2 segment of middle cerebral artery, basilar artery, or vertebral artery; the degree of stenosis is determined by magnetic resonance angiography, computed tomography angiography, digital subtraction angiography using the standards of warfarin-aspirin symptomatic intracranial disease );
- mRS (modified Rankin Scale)≤4;
- The patient himself or his legal representative signs the informed consent form.
You may not qualify if:
- Stroke progression within the past 3 days (defined as an increase in the score of National Institute of Health Stroke Scale ≥4 points or an increase in individual items of ≥2 points).
- mRS≥1 before the stroke onset.
- Concurrent osteoarthritis, fracture, lower limb venous thrombosis, unstable angina pectoris, respiratory diseases, limb disabilities, etc., making it theoretically difficult to cooperate with the physical activity plan for this trial.
- Complicated with motor disorders such as Parkinson\'s disease and Parkinson\'s syndrome.
- The vessels responsible for this stroke had tandem lesions (more than 50% of extracranial artery stenosis).
- The vessel responsible for this stroke has undergone intracranial balloon angioplasty and/or stent implantation (except for mechanical thrombectomy and/or aspiration alone).
- It is expected that intracranial arterial balloon angioplasty and/or stent implantation will be performed on the vessel responsible for the stroke within 3 months.
- Patients who exercised regularly within the last 6 months. Regular exercise is defined as four or more moderate intensity exercises per week for more than 10 minutes each time or two or more high intensity exercises per week for more than 10 minutes each time.
- Inability to understand and/or comply with the trial procedures and/or follow-up due to mental illness, cognitive or emotional disorders.
- Life expectancy is less than one year.
- Women who are known to be pregnant or nursing, or have a positive pregnancy test;
- Are participating in other drug or device research.
- There are other circumstances that investigators consider are not suitable for enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (58)
Taihe Hospital of Traditional Chinese Medicine
Fuyang, Anhui, China
Huainan Sunshine Xinkang Hospital
Huainan, Anhui, China
Suzhou Municipal Hospital
Suzhou, Anhui, 234000, China
The Second People's Hospital of Wuhu
Wuhu, Anhui, China
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053, China
Beijing Pinggu District Hospital
Beijing, Beijing Municipality, China
Chongqing Sanbo Jiangling Hospital
Chongqing, Chongqing Municipality, China
Zhangzhou Hospital
Zhangzhou, Fu, China
Foshan Fifth People's Hospital
Foshan, Guangdong, China
Foshan Nanhai District Sixth People's Hospital
Foshan, Guangdong, China
Brain Hospital Affiliated to Guangzhou Medical University
Guangzhou, Guangdong, China
Longchuan Hospital of Traditional Chinese Medicine
Heyuan, Guangdong, China
Hospital 925, Joint Logistics Support Force
Guizhou, Guiyang, China
Cangzhou People's Hospital of integrated Chinese and Western Medicine, Hebei Province
Cangzhou, Hebei, China
Army Military Medical University Officer School affiliated hospital
Shijiazhuang, Hebei, China
Tangshan Workers' Hospital
Tangshan, Hebei, China
Ningjin County Hospital
Xingtai, Hebei, China
Gongyi Xinhua Hospital of Traditional Chinese Medicine
Gongyi, Henan, China
Tongxu First Hospital
Kaifeng, Henan, China
Fangcheng County People's Hospital
Nanyang, Henan, China
Nanyang City Center Hospital
Nanyang, Henan, China
Shangqiu First People's Hospital
Shangqiu, Henan, China
Yongcheng Central Hospital
Shangqiu, Henan, China
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan, China
Zhengzhou First People's Hospital
Zhengzhou, Henan, China
Zhengzhou Zhongkang Hospital
Zhengzhou, Henan, China
Zhongmou County People's Hospital
Zhengzhou, Henan, China
Xihua County People's Hospital
Zhoukou, Henan, China
Lichuan Ethnic Chinese Medicine Hospital
Lichuan, Hubei, China
Hubei Third People's Hospital
Wuhan, Hubei, China
Yueyang City People's Court
Yueyang, Hubei, China
Liuyang City Jili Hospital
Guankou, Hunan, 410300, China
Xiangtan Central Hospital
Xiangtan, Hunan, China
Jiujiang First People's Hospital
Jiujiang, Jiangxi, China
Jilin City People's Hospital
Jilin, Jilin, China
Xinmin People's Hospital
Shenyang, Liaoning, China
Affiliated Hospital of Inner Mongolia University for Nationalities
Tongliao, Neimenggu, China
Yantai Yeda Hospital
Yantai, Shaanxi, China
Shandong University Qilu Hospital Dezhou Hospital
Dezhou, Shandong, China
Shengli Oilfield Central Hospital
Dongying, Shandong, China
Jinan High-tech East District Hospital
Jinan, Shandong, China
Laixi People's Hospital
Laixi, Shandong, China
Liaocheng People's Hospital
Liaocheng, Shandong, China
Lanshan District People's Hospital
Rizhao, Shandong, China
Affiliated Hospital of Shandong Second Medical University
Weifang, Shandong, China
Yantai Fushan District People's Hospital
Yantai, Shandong, China
Tengzhou Central Hospital
Zaozhuang, Shandong, China
Ningjin County People's Hospital
Dezhou, Shangdong, China
Shanghai Hechuan Rhein Hospital of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Sichuan Academy of Sciences Hospital
Chengdu, Sichuan, China
Jianyang City Hospital of Traditional Chinese Medicine
Jiancheng, Sichuan, China
Ya 'an People's Hospital
Yaan, Sichuan, China
Shihezi People's Hospital
Shihezi, Xinjiang, 836800, China
Yongjia County People's Hospital
Wenzhou, Zhejiang, China
Yueqing People's Hospital
Wenzhou, Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 24, 2024
First Posted
September 27, 2024
Study Start
October 10, 2024
Primary Completion (Estimated)
November 19, 2026
Study Completion (Estimated)
November 19, 2026
Last Updated
November 25, 2025
Record last verified: 2025-11