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NCT Number: NCT07242768

Follow-up Extension Study of Regular Physical Exercise in Patients With Symptomatic Intracranial Arterial Stenosis

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xuanwu Hospital, Capital Medical University

Beijing, China

Location status: Recruiting

Location contact

Chuanjie Wu

CONTACT

[email protected]

01083199439

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

Participants who withdrew consent in the RESIST trial, decline to participate in this extension, or were lost to follow-up at 12 months.

Treatment and study plan

Non-Interventional Study

Other

After completing 12-month intervention from RESIST trial, investigators would not make any interventions or impact on subjects.

Primary outcomes

  1. New ischemic stroke events

    Time frame: Within 3 years after randomization

Secondary outcomes

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

    Time frame: Within 3 years after randomization

  2. New ischemic stroke and transient ischemic attack events

    Time frame: Within 3 years after randomization

  3. Hemorrhagic stroke events

    Time frame: Within 3 years after randomization

  4. Myocardial infarction events

    Time frame: Within 3 years after randomization

  5. Proportion of patients achieving modified Rankin Scale score (mRS) 0-1

    Time frame: At 3 years after randomization

    The modified Rankin scale (range, 0 [no symptoms] to 6 [death], with higher scores indicating greater disability)

  6. The score of mini-Montreal Cognitive Assessment

    Time frame: At 3 years after randomization

    The score of mini-Montreal Cognitive Assessment (range, 0 to 15, with higher scores indicating greater cognition)

  7. Quality of life assessed by EuroQol 5 Dimensions 5 level questionnaire (EQ-5D-5L)

    Time frame: At 3 years after randomization

    The EQ-5D-5L includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= n

  8. Rate of Falls

    Time frame: Within 3 years after randomization

  9. All-cause death

    Time frame: Within 3 years after randomization

Study contacts

Contact information is provided by the study sponsor or research team.

Chuanjie Wu

CONTACT

[email protected]

01083199439

Xunming Ji

CONTACT

[email protected]

01083198962

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

Regular Physical Exercise in Patients With Symptomatic Intracranial Arterial Stenosis: Three-year Follow-up of RESIST Trial

Acronym: RESIST-FE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Nov 21, 2025
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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