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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.
The intracranial atherosclerotic stenosis (ICAS) is a common cause of ischemic stroke, and the result of increasing global burden of stroke. There are significant racial differences in the incidence of ICAS, which account for 8%-10% of stroke causes in North America and 30%-50% in Asia. In China, the incidence of ICAS in patients with ischemic stroke or transient ischemic attack (TIA) is as high as 46.6%. Previous studies have shown that stroke patients with ICAS have more severe symptoms, longer hospital stay and higher stroke recurrence rate, and the recurrence rate of stroke increases with the increase of stenosis degree. In the WASID (Warfarin-Aspirin Symptomatic Intracranial Disease trial and several prospective cohort studies) trial, the risk of recurrent stroke remained high even after aggressive medication and risk factor intervention in ICAS patients.
At present, the treatment of ICAS mainly includes drug therapy and endovascular therapy. Both the SAMMPRIS (Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis) trial in 2011 and the VISSIT (the Vitesse Intracranial Stent Study for Ischemic Stroke Therapy) trial in 2015, showed that aggressive medical treatment is more effective and safer than endovascular treatment . A 2018 review comparing stenting versus aggressive medical treatment for symptomatic ICAS also noted that medical treatment remains the preferred treatment for symptomatic ICAS patients compared to endovascular therapy. The results of the CASSISS trial in 2022, showed that endovascular therapy failed to show long-term benefit in severe patients with symptomatic ICAS. However, the above trials also found that even with aggressive medical treatment including dual antiplatelet therapy and intensive management of vascular risk factors, the one-year stroke recurrence rate in patients with symptomatic ICAS is still as high as 20%. This seriously endangers national lives and health, and restricts social and economic development. Therefore, there is an urgent need to explore new treatments to improve patient survival.
Several previous studies have shown that physical exercise can reduce the incidence of all-cause stroke, cardiovascular disease and death, but little is known whether it can reduce the recurrence rate of stroke in patients with symptomatic ICAS. A subgroup analysis of the 2016 SAMMPPRIS trial found that in high-risk symptomatic ICAS patients, physical exercise significantly reduced the likelihood of recurrent stroke, myocardial infarction, or vascular death. A 2023 cross-sectional study that included NOMAS (Northern Manhattan Study) data showed a strong negative association between physical exercise and asymptomatic high-risk ICAS and was not regulated by vascular risk factors. Therefore, this trial conducts a multicenter, randomized, controlled, blinded trial of patients with symptomatic ICAS within 30 days to compare them with a control group that received only secondary stroke prevention health education to determine the association between regular physical exercise and stroke recurrence rates within 1 year in patients with symptomatic ICAS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| regular physical exercise group | Experimental |
| |
| Control group | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regular physical exercise | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| New ischemic stroke events | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Measure | Description | Time Frame |
|---|---|---|
| Falls | 1 year | |
| All-cause death | 1 year |
1. Inclusion criteria:
2. Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taihe Hospital of Traditional Chinese Medicine | Fuyang | Anhui | China | |||
| Huainan Sunshine Xinkang Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42052962 | Derived | Zhang W, Liu Y, Zhang W, Jia X, Yu E, Yao L, Ma Z, Zhu D, Ya N, Wu S, He Y, Song Z, Hou C, Ji X, Wu C. Home-Based RESIST: Rationale and Design of a Multicenter Randomized Controlled Trial. J Am Heart Assoc. 2026 May 5;15(9):e046662. doi: 10.1161/JAHA.125.046662. Epub 2026 Apr 29. |
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|
| Control group | Other | Best medical treatment |
|
| 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 |
| The score of min montreal cognitive assessment(range, 0 to 15, with higher scores indicating greater cognition) | 1 year |
| The score of Euro-QoL-5 Dimension(range, 0 to 100, with higher scores indicating better quality of life) | 1 year |
| 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 City | 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 |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D002546 | Ischemic Attack, Transient |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002545 | Brain Ischemia |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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