Regular Physical Exercise in Patients With Symptomatic Intracranial Arterial Stenosis

NCT ID: NCT06615726

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-10
• Study Completion Date: 2026-11-19

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.

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 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.

Conditions

Ischemic Stroke; Transient Ischemic Attack

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

regular physical exercise group

Group Type: EXPERIMENTAL

Regular physical exercise

Intervention Type: 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.

Control group

Group Type: OTHER

Control group

Intervention Type: OTHER

Best medical treatment

Interventions

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.

Intervention Type: BEHAVIORAL

Control group

Best medical treatment

Intervention Type: OTHER

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ji Xunming,MD,PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Countries

China

Other Identifiers

SPORTS1101

Identifier Type: -

Identifier Source: org_study_id