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NCT06615726

PHASE3

Regular Physical Exercise in Patients With Symptomatic Intracranial Arterial Stenosis

Sponsor: Capital Medical University

View on ClinicalTrials.gov

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.

Official title: Regular Physical Exercise in Patients With Symptomatic Intracranial Arterial Stenosis: a Prospective Randomized Open-label Blinded Endpoint Trial

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

1300

Start Date

2024-10-10

Completion Date

2026-11-19

Last Updated

2025-11-25

Healthy Volunteers

Conditions

Ischemic Stroke Transient Ischemic Attack

Interventions

BEHAVIORAL

Regular physical exercise

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.

OTHER

Control group

Best medical treatment

1\. Inclusion criteria: 1. Age ≥40 years and ≤80 years; 2. Ischemic stroke or TIA (transient ischemic attack) onset ≤30 days; 3. 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 ); 4. mRS (modified Rankin Scale)≤4; 5. The patient himself or his legal representative signs the informed consent form. 2\. Exclusion criteria: 1. 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). 2. mRS≥1 before the stroke onset. 3. 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. 4. Complicated with motor disorders such as Parkinson\'s disease and Parkinson\'s syndrome. 5. The vessels responsible for this stroke had tandem lesions (more than 50% of extracranial artery stenosis). 6. The vessel responsible for this stroke has undergone intracranial balloon angioplasty and/or stent implantation (except for mechanical thrombectomy and/or aspiration alone). 7. 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. 8. 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. 9. Inability to understand and/or comply with the trial procedures and/or follow-up due to mental illness, cognitive or emotional disorders. 10. Life expectancy is less than one year. 11. Women who are known to be pregnant or nursing, or have a positive pregnancy test; 12. Are participating in other drug or device research. 13. There are other circumstances that investigators consider are not suitable for enrollment.

Locations (58)

Taihe Hospital of Traditional Chinese Medicine

Fuyang, Anhui, China

Huainan Sunshine Xinkang Hospital

Huainan, Anhui, China

Suzhou Municipal Hospital

Suzhou, Anhui, China

The Second People's Hospital of Wuhu

Wuhu, Anhui, China

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 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, 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, 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, China

Yongjia County People's Hospital

Wenzhou, Zhejiang, China

Yueqing People's Hospital

Wenzhou, Zhejiang, China

Clinical Research Directory

Regular Physical Exercise in Patients With Symptomatic Intracranial Arterial Stenosis

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (58)