Regular Physical Activity in Patients With Symptomatic Intracranial Arterial Stenosis
- Conditions
- Ischemic StrokeTransient Ischemic Attack
- Interventions
- Behavioral: Regular physical activityOther: Control group
- Registration Number
- NCT06615726
- Lead Sponsor
- Capital Medical University
- Brief Summary
The objective of this study is to evaluate the effectiveness and safety of regular physical activity in preventing ischemic stroke events in patients with symptomatic intracranial arterial stenosis.
- Detailed Description
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 activity 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 activity 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 activity 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 activity and stroke recurrence rates within 1 year in patients with symptomatic ICAS.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1300
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description regular physical activity group Regular physical activity - Control group Control group -
- Primary Outcome Measures
Name Time Method New ischemic stroke events 1 year
- Secondary Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (58)
Taihe Hospital of Traditional Chinese Medicine
π¨π³Fuyang, Anhui, China
Huainan Sunshine Xinkang Hospital
π¨π³Huainan, Anhui, China
Suzhou Municipal Hospital
π¨π³Suzhou, Anhui, China
The Second People's Hospital of Wuhu
π¨π³Wuhu, Anhui, China
Xuanwu Hospital, Capital Medical University
π¨π³Beijing, Beijing, China
Beijing Pinggu District Hospital
π¨π³Beijing, Beijing, China
Chongqing Sanbo Jiangling Hospital
π¨π³Chongqing, Chongqing, China
Zhangzhou Hospital
π¨π³Zhangzhou, Fujian, China
Foshan Fifth People's Hospital
π¨π³Foshan, Guangdong, China
Foshan Nanhai District Sixth People's Hospital
π¨π³Foshan, Guangdong, China
Brain Hospital Affiliated to Guangzhou Medical University
π¨π³Guangzhou, Guangdong, China
Longchuan Hospital of Traditional Chinese Medicine
π¨π³Heyuan, Guangdong, China
Hospital 925, Joint Logistics Support Force
π¨π³Guizhou, Guiyang, China
Cangzhou People's Hospital of integrated Chinese and Western Medicine, Hebei Province
π¨π³Cangzhou, Hebei, China
Army Military Medical University Officer School affiliated hospital
π¨π³Shijiazhuang, Hebei, China
Tangshan Workers' Hospital
π¨π³Tangshan, Hebei, China
Ningjin County Hospital
π¨π³Xingtai, Hebei, China
Gongyi Xinhua Hospital of Traditional Chinese Medicine
π¨π³Gongyi, Henan, China
Tongxu First Hospital
π¨π³Kaifeng, Henan, China
Fangcheng County People's Hospital
π¨π³Nanyang, Henan, China
Nanyang City Center Hospital
π¨π³Nanyang, Henan, China
Shangqiu First People's Hospital
π¨π³Shangqiu, Henan, China
Yongcheng Central Hospital
π¨π³Shangqiu, Henan, China
The First Affiliated Hospital of Xinxiang Medical College
π¨π³Xinxiang, Henan, China
The First Affiliated Hospital of Zhengzhou University
π¨π³Zhengzhou, Henan, China
Henan Provincial People's Hospital
π¨π³Zhengzhou, Henan, China
The First Affiliated Hospital of Henan University of Chinese Medicine
π¨π³Zhengzhou, Henan, China
Zhengzhou First People's Hospital
π¨π³Zhengzhou, Henan, China
Zhengzhou Zhongkang Hospital
π¨π³Zhengzhou, Henan, China
Zhongmou County People's Hospital
π¨π³Zhengzhou, Henan, China
Xihua County People's Hospital
π¨π³Zhoukou, Henan, China
Lichuan Ethnic Chinese Medicine Hospital
π¨π³Lichuan, Hubei, China
Hubei Third People's Hospital
π¨π³Wuhan, Hubei, China
Yueyang City People's Court
π¨π³Yueyang, Hubei, China
Liuyang City Jili Hospital
π¨π³Liuyang, Hunan, China
Xiangtan Central Hospital
π¨π³Xiangtan, Hunan, China
Jiujiang First People's Hospital
π¨π³Jiujiang, Jiangxi, China
Jilin City People's Hospital
π¨π³Jilin, Jilin, China
Xinmin People's Hospital
π¨π³Shenyang, Liaoning, China
Affiliated Hospital of Inner Mongolia University for Nationalities
π¨π³Tongliao, Neimenggu, China
Shandong University Qilu Hospital Dezhou Hospital
π¨π³Dezhou, Shandong, China
Shengli Oilfield Central Hospital
π¨π³Dongying, Shandong, China
Jinan High-tech East District Hospital
π¨π³Jinan, Shandong, China
Laixi People's Hospital
π¨π³Laixi, Shandong, China
Liaocheng People's Hospital
π¨π³Liaocheng, Shandong, China
Lanshan District People's Hospital
π¨π³Rizhao, Shandong, China
Affiliated Hospital of Shandong Second Medical University
π¨π³Weifang, Shandong, China
Yantai Fushan District People's Hospital
π¨π³Yantai, Shandong, China
Tengzhou Central Hospital
π¨π³Zaozhuang, Shandong, China
Ningjin County People's Hospital
π¨π³Dezhou, Shangdong, China
Shanghai Hechuan Rhein Hospital of Traditional Chinese Medicine
π¨π³Shanghai, Shanghai, China
Yantai Yeda Hospital
π¨π³Yantai, Shan, China
Sichuan Academy of Sciences Hospital
π¨π³Chengdu, Sichuan, China
Jianyang City Hospital of Traditional Chinese Medicine
π¨π³Jianyang, Sichuan, China
Ya 'an People's Hospital
π¨π³Yaan, Sichuan, China
Shihezi People's Hospital
π¨π³Shihezi, Xinjiang, China
Yongjia County People's Hospital
π¨π³Wenzhou, Zhejiang, China
Yueqing People's Hospital
π¨π³Wenzhou, Zhejiang, China