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Ischemic StrokePhase 3RESISTNCT06615726

Regular Physical Exercise in Patients With Symptomatic Intracranial Arterial Stenosis

A Phase 3 study testing Regular physical exercise in people with Ischemic Stroke and Transient Ischemic Attack, run by Capital Medical University at 58 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Ischemic Stroke, Transient Ischemic Attack
What is being tested?
Regular physical exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,300 participants
Where
58 sitesChina
Study dates
10 Oct 2024to 19 Nov 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  1. Inclusion criteria:
  2. Age ≥40 years and ≤80 years;
  3. Ischemic stroke or TIA (transient ischemic attack) onset ≤30 days;
  4. 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 );
  5. mRS (modified Rankin Scale)≤4;
  6. The patient himself or his legal representative signs the informed consent form.
  7. Exclusion criteria:
  8. 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).
  9. mRS≥1 before the stroke onset.
  10. 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.
  11. Complicated with motor disorders such as Parkinson\'s disease and Parkinson\'s syndrome.
  12. The vessels responsible for this stroke had tandem lesions (more than 50% of extracranial artery stenosis).
  13. The vessel responsible for this stroke has undergone intracranial balloon angioplasty and/or stent implantation (except for mechanical thrombectomy and/or aspiration alone).
  14. 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.
  15. 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.
  16. Inability to understand and/or comply with the trial procedures and/or follow-up due to mental illness, cognitive or emotional disorders.
  17. Life expectancy is less than one year.
  18. Women who are known to be pregnant or nursing, or have a positive pregnancy test;
  19. Are participating in other drug or device research.
  20. There are other circumstances that investigators consider are not suitable for enrollment.

Trial locations and contacts

58 sites in 1 country.

58 sites in 1 country

China58 sites

  • Xuanwu Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100053

  • Beijing Pinggu District Hospital

    Beijing, Beijing Municipality

  • Cangzhou People's Hospital of integrated Chinese and Western Medicine, Hebei Province

    Cangzhou, Hebei

  • Sichuan Academy of Sciences Hospital

    Chengdu, Sichuan

  • Chongqing Sanbo Jiangling Hospital

    Chongqing, Chongqing Municipality

  • Shandong University Qilu Hospital Dezhou Hospital

    Dezhou, Shandong

  • Ningjin County People's Hospital

    Dezhou, Shangdong

  • Shengli Oilfield Central Hospital

    Dongying, Shandong

  • Foshan Fifth People's Hospital

    Foshan, Guangdong

  • Foshan Nanhai District Sixth People's Hospital

    Foshan, Guangdong

  • Taihe Hospital of Traditional Chinese Medicine

    Fuyang, Anhui

  • Gongyi Xinhua Hospital of Traditional Chinese Medicine

    Gongyi, Henan

  • Brain Hospital Affiliated to Guangzhou Medical University

    Guangzhou, Guangdong

  • Liuyang City Jili Hospital

    Guankou, Hunan, 410300

  • Hospital 925, Joint Logistics Support Force

    Guizhou, Guiyang

  • Longchuan Hospital of Traditional Chinese Medicine

    Heyuan, Guangdong

  • Huainan Sunshine Xinkang Hospital

    Huainan, Anhui

  • Jianyang City Hospital of Traditional Chinese Medicine

    Jiancheng, Sichuan

  • Jilin City People's Hospital

    Jilin City, Jilin

  • Jinan High-tech East District Hospital

    Jinan, Shandong

  • Jiujiang First People's Hospital

    Jiujiang, Jiangxi

  • Tongxu First Hospital

    Kaifeng, Henan

  • Laixi People's Hospital

    Laixi, Shandong

  • Liaocheng People's Hospital

    Liaocheng, Shandong

  • Lichuan Ethnic Chinese Medicine Hospital

    Lichuan, Hubei

  • Fangcheng County People's Hospital

    Nanyang, Henan

  • Nanyang City Center Hospital

    Nanyang, Henan

  • Lanshan District People's Hospital

    Rizhao, Shandong

  • Shanghai Hechuan Rhein Hospital of Traditional Chinese Medicine

    Shanghai, Shanghai Municipality

  • Shangqiu First People's Hospital

    Shangqiu, Henan

  • Yongcheng Central Hospital

    Shangqiu, Henan

  • Xinmin People's Hospital

    Shenyang, Liaoning

  • Shihezi People's Hospital

    Shihezi, Xinjiang, 836800

  • Army Military Medical University Officer School affiliated hospital

    Shijiazhuang, Hebei

  • Suzhou Municipal Hospital

    Suzhou, Anhui, 234000

  • Tangshan Workers' Hospital

    Tangshan, Hebei

  • Affiliated Hospital of Inner Mongolia University for Nationalities

    Tongliao, Neimenggu

  • Affiliated Hospital of Shandong Second Medical University

    Weifang, Shandong

  • Yongjia County People's Hospital

    Wenzhou, Zhejiang

  • Yueqing People's Hospital

    Wenzhou, Zhejiang

  • Hubei Third People's Hospital

    Wuhan, Hubei

  • The Second People's Hospital of Wuhu

    Wuhu, Anhui

  • Xiangtan Central Hospital

    Xiangtan, Hunan

  • Ningjin County Hospital

    Xingtai, Hebei

  • The First Affiliated Hospital of Xinxiang Medical College

    Xinxiang, Henan

  • Ya 'an People's Hospital

    Yaan, Sichuan

  • Yantai Yeda Hospital

    Yantai, Shaanxi

  • Yantai Fushan District People's Hospital

    Yantai, Shandong

  • Yueyang City People's Court

    Yueyang, Hubei

  • Tengzhou Central Hospital

    Zaozhuang, Shandong

  • Zhangzhou Hospital

    Zhangzhou, Fu

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450000

  • Henan Provincial People's Hospital

    Zhengzhou, Henan

  • The First Affiliated Hospital of Henan University of Chinese Medicine

    Zhengzhou, Henan

  • Zhengzhou First People's Hospital

    Zhengzhou, Henan

  • Zhengzhou Zhongkang Hospital

    Zhengzhou, Henan

  • Zhongmou County People's Hospital

    Zhengzhou, Henan

  • Xihua County People's Hospital

    Zhoukou, Henan

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Regular physical exercise, Control group
Keywords
Ischemic stroke, Transient Ischemic Attack, Symptomatic intracranial arterial stenosis
Medical subject headings
Ischemic Stroke, Ischemic Attack, Transient

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Regular physical exerciseBehavioural

    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 groupOther

    Best medical treatment

Study groups in NCT06615726
Study groupRoleWhat they receive
regular physical exercise groupExperimentalNot described
Receives: Behavioral: Regular physical exercise
Control groupOtherNot described
Receives: Other: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. New ischemic stroke events

    Measured: 1 year

Secondary outcomes (7)

  1. New ischemic stroke and transient ischemic attack events in the responsible vessel supply area

    Measured: 1 year

  2. New ischemic stroke and transient ischemic attack events

    Measured: 1 year

  3. Hemorrhagic stroke event

    Measured: 1 year

  4. Myocardial infarction

    Measured: 1 year

  5. The proportion of modified Rankin Scale score 0-1 (range, 0 to 6, with higher scores indicating greater disability)

    Measured: 1 year

  6. The score of min montreal cognitive assessment(range, 0 to 15, with higher scores indicating greater cognition)

    Measured: 1 year

  7. The score of Euro-QoL-5 Dimension(range, 0 to 100, with higher scores indicating better quality of life)

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2024
  2. Study start10 Oct 2024
  3. Primary completion19 Nov 2026 (estimated)
  4. Study completion19 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06615726
Sponsor's protocol ID
SPORTS1101
Acronym
RESIST
Status last verified
Nov 2025
First submitted
24 Sep 2024
Last updated
25 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 42052962

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Regular physical exercise in people with Ischemic Stroke and Transient Ischemic Attack, run by Capital Medical University at 58 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

New ischemic stroke events (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06615726, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.

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