Ischemic StrokeRESIST-FENCT07242768
Follow-up Extension Study of Regular Physical Exercise in Patients With Symptomatic Intracranial Arterial Stenosis
An observational study of Ischemic Stroke and Transient Ischemic Attack, run by Capital Medical University at 1 site in China.
Trial summary
This study will include the subjects with symptomatic intracranial arterial stenosis (ICAS) who have participated in and completed the 1-year follow-up of RESIST trial (NCT06615726). 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?
- Non-Interventional Study
- How many people
- 1,300 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2026to 30 Nov 2028
- Phase
- Observational
- 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
Study population: This study will include the subjects who enrolled in the RESIST trial.
Who may be able to join
- Participants who enrolled in the RESIST trial and completed the 12-month follow-up.
- Written informed consent to participate in this 3-year observational extension.
Who cannot join
- Participants who withdrew consent in the RESIST trial, decline to participate in this extension, or were lost to follow-up at 12 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing
Chuanjie Wu, 01083199439, wuchuanjie@ccmu.edu.cn
About this study
Official title: Regular Physical Exercise in Patients With Symptomatic Intracranial Arterial Stenosis: Three-year Follow-up of RESIST Trial
This study will include the subjects with symptomatic intracranial arterial stenosis (ICAS) who have participated in and completed the 1-year follow-up of RESIST trial (NCT06615726). The aim is to observe the long-term clinical outcomes over 3 years after a 1-year regular physical exercise intervention in patients with symptomatic ICAS.
Read the detailed description
This is a non-interventional, observational study designed to investigate long-term clinical outcomes in symptomatic ICAS patients who have already enrolled in RESIST trial and completed the 1-year follow-up.
After completing 12-month randomized intervention from RESISR trial, investigators continue to follow the subjects up to 3 years without any further intervention or changes to routine clinical management. The primary endpoint is the incidence of new ischemic stroke within 3 years. Secondary endpoints include new ischemic stroke and transient ischemic attack events in the responsible vessel supply area within 3 years; new ischemic stroke and transient ischemic attack events within 3 years; hemorrhagic stroke event within 3 years; myocardial infarction within 3 years; falls within 3 years; all-cause death within 3 years; the proportion of patients with modified Rankin Scale score 0-1 at 3 years; the score of mini-Montreal Cognitive Assessment at 3 years; and the score of EuroQol 5-Dimension 5-Level at 3 years.
Approximately 1,300 subjects who have completed the RESIST trial's 1-year follow-up and consented to continue will be included. The overall study duration will extend from the first participant's entry into the observation period until the last participant completes the 3-year follow-up.
- Conditions
- Ischemic Stroke, Transient Ischemic Attack
- Being tested
- Non-Interventional Study
- 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.
Non-Interventional StudyOther
After completing 12-month intervention from RESIST trial, investigators would not make any interventions or impact on subjects.
| Study group | Role | What they receive |
|---|---|---|
| Regular Physical Exercise Group | Participants with symptomatic ICAS who were assigned to the regular physical exercise intervention in the RESIST trial and completed the 12-month follow-up. Receives: Other: Non-Interventional Study | |
| Control Group | Participants with symptomatic ICAS who were assigned to the control group in the RESIST trial and completed the 12-month follow-up. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
New ischemic stroke events
Measured: Within 3 years after randomization
Secondary outcomes (9)
New ischemic stroke and transient ischemic attack events in the responsible vessel supply area
Measured: Within 3 years after randomization
New ischemic stroke and transient ischemic attack events
Measured: Within 3 years after randomization
Hemorrhagic stroke events
Measured: Within 3 years after randomization
Myocardial infarction events
Measured: Within 3 years after randomization
Proportion of patients achieving modified Rankin Scale score (mRS) 0-1
The modified Rankin scale (range, 0 [no symptoms] to 6 [death], with higher scores indicating greater disability)
Measured: At 3 years after randomization
The score of mini-Montreal Cognitive Assessment
The score of mini-Montreal Cognitive Assessment (range, 0 to 15, with higher scores indicating greater cognition)
Measured: At 3 years after randomization
Quality of life assessed by EuroQol 5 Dimensions 5 level questionnaire (EQ-5D-5L)
The EQ-5D-5L includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= n
Measured: At 3 years after randomization
Rate of Falls
Measured: Within 3 years after randomization
All-cause death
Measured: Within 3 years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start10 Jan 2026
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242768
- Sponsor's protocol ID
- SPORTS1102
- Acronym
- RESIST-FE
- Status last verified
- Jan 2026
- First submitted
- 17 Nov 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study is proceeding.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regular Physical Exercise in Patients With Symptomatic Intracranial Arterial Stenosis: Three-year Follow-up of RESIST Trial
- ClinicalTrials.gov ID
- NCT07242768
- Acronym / sponsor ID
- RESIST-FE / SPORTS1102
- Conditions
- Ischemic Stroke, Transient Ischemic Attack
- Keywords
- Ischemic Stroke, Transient Ischemic Attack, Symptomatic intracranial arterial stenosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 10 Jan 2026 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will include the subjects with symptomatic intracranial arterial stenosis (ICAS) who have participated in and completed the 1-year follow-up of RESIST trial (NCT06615726). The aim is to observe the long-term clinical outcomes over 3 years after a 1-year regular physical exercise intervention in patients with symptomatic ICAS.
Detailed description
This is a non-interventional, observational study designed to investigate long-term clinical outcomes in symptomatic ICAS patients who have already enrolled in RESIST trial and completed the 1-year follow-up.
After completing 12-month randomized intervention from RESISR trial, investigators continue to follow the subjects up to 3 years without any further intervention or changes to routine clinical management. The primary endpoint is the incidence of new ischemic stroke within 3 years. Secondary endpoints include new ischemic stroke and transient ischemic attack events in the responsible vessel supply area within 3 years; new ischemic stroke and transient ischemic attack events within 3 years; hemorrhagic stroke event within 3 years; myocardial infarction within 3 years; falls within 3 years; all-cause death within 3 years; the proportion of patients with modified Rankin Scale score 0-1 at 3 years; the score of mini-Montreal Cognitive Assessment at 3 years; and the score of EuroQol 5-Dimension 5-Level at 3 years.
Approximately 1,300 subjects who have completed the RESIST trial's 1-year follow-up and consented to continue will be included. The overall study duration will extend from the first participant's entry into the observation period until the last participant completes the 3-year follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular Physical Exercise Group | – | Other: Non-Interventional StudyParticipants with symptomatic ICAS who were assigned to the regular physical exercise intervention in the RESIST trial and completed the 12-month follow-up. |
| Control Group | – | Other: Non-Interventional StudyParticipants with symptomatic ICAS who were assigned to the control group in the RESIST trial and completed the 12-month follow-up. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include the subjects who enrolled in the RESIST trial.
Key inclusion criteria (2 listed)
- Participants who enrolled in the RESIST trial and completed the 12-month follow-up.
- Written informed consent to participate in this 3-year observational extension.
Key exclusion criteria (1 listed)
- Participants who withdrew consent in the RESIST trial, decline to participate in this extension, or were lost to follow-up at 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyAfter completing 12-month intervention from RESIST trial, investigators would not make any interventions or impact on subjects. | Other | Control Group, Regular Physical Exercise Group |
Primary outcome
New ischemic stroke events
Time frame: Within 3 years after randomization
9 secondary outcomes
New ischemic stroke and transient ischemic attack events in the responsible vessel supply area
Time frame: Within 3 years after randomization
New ischemic stroke and transient ischemic attack events
Time frame: Within 3 years after randomization
Hemorrhagic stroke events
Time frame: Within 3 years after randomization
Myocardial infarction events
Time frame: Within 3 years after randomization
Proportion of patients achieving modified Rankin Scale score (mRS) 0-1
Time frame: At 3 years after randomization
The score of mini-Montreal Cognitive Assessment
Time frame: At 3 years after randomization
Quality of life assessed by EuroQol 5 Dimensions 5 level questionnaire (EQ-5D-5L)
Time frame: At 3 years after randomization
Rate of Falls
Time frame: Within 3 years after randomization
All-cause death
Time frame: Within 3 years after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No. The study is proceeding.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Transient Ischemic Attack, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Contact Xunming Ji (01083198962, jixm@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New ischemic stroke events (time frame: Within 3 years after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2026.