Acute Ischemic StrokeHOPE-STROKE 2NCT07271082
Efficacy and Safety of Home-based Structured Physical Exercise in Patients With Acute Ischemic Stroke
A study testing Exercise intervention in people with Acute Ischemic Stroke, run by Capital Medical University at 6 sites in China.
Trial summary
This study is a randomized controlled, open-label, blinded endpoint trial. The investigators aim to assess the efficacy and safety of home-based structured physical exercise in participants with acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 6 sitesChina
- Study dates
- 18 Dec 2025to 14 Aug 2027
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or greater, male or female;
- Acute ischemic stroke onset within 14 days;
- modified Rankin scale (mRS) score ≤ 3;
- Signed informed consent from the patients or the legally authorized representatives.
Who cannot join
- Stroke progression within the past 3 days (defined as an increase in NIHSS score of ≥4 points or an increase in any single item of ≥2 points);
- Concurrent osteoarthritis, fractures, deep vein thrombosis, unstable angina, severe heart diseases, respiratory diseases, or amputation that may theoretically make it difficult for participants to complete the physical exercise or ambulation;
- Concurrent movement disorders such as Parkinson's disease or Parkinsonism;
- Patients who have engaged in regular aerobic physical activity within the past 6 months, defined as more than 150 minutes of moderate-intensity aerobic physical activity; or more than 75 minutes of vigorous-intensity aerobic physical activity; or an equivalent combination of moderate- and vigorous-intensity activity throughout the week;
- Unable to comply with the study procedures or follow-up due to psychiatric, cognitive, or emotional disorders;
- Known pregnancy or lactation, or a positive pregnancy test;
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- Currently participating in another drug or device study;
- Life expectancy less than 1 year;
- Unable to communicate using a smartphone;
- Other conditions considered by investigators to be unsuitable for inclusion.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Beijing Pinggu District Hospital
Beijing, Beijing Municipality
Xuanwu Hospital, Capital Medical University, 100053
Beijing
Taihe Hospital of Traditional Chinese Medicine
Fuyang, Anhui
Shihezi People's Hospital
Shihezi, Xinjiang, 836800
Suzhou Municipal Hospital
Suzhou, Anhui, 234000
Xihua County People's Hospital
Zhoukou, Henan
About this study
Official title: Efficacy and Safety of Home-based Structured Physical Exercise in Patients With Acute Ischemic Stroke: a Randomized Controlled, Open-label, Blinded Endpoint Trial-2 (HOPE-STROKE 2)
This study is a randomized controlled, open-label, blinded endpoint trial. The investigators aim to assess the efficacy and safety of home-based structured physical exercise in participants with acute ischemic stroke.
Read the detailed description
The study population is participants with acute ischemic stroke within 14 days of onset. All participants are randomly assigned to the exercise intervention group or the control group in a 1:1 ratio. In the exercise intervention group, participants will undergo 90 days of home-based structured physical exercise guidance. The individualized exercise prescription will be determined based on each participant's overall condition. In the control group, participants will not receive structured physical exercise guidance but are encouraged to engage in regular physical exercise. Both groups of participants will receive standard medical management based on the latest guidelines from the American Heart Association/American Stroke Association.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Exercise intervention
- Keywords
- Acute Ischemic Stroke, Physical Exercise
- Medical subject headings
- Ischemic Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise interventionBehavioural
Subjects will undergo 90 days of home-based structured physical exercise guidance.
| Study group | Role | What they receive |
|---|---|---|
| Exercise intervention group | Experimental | Home-based structured physical exercise guidance. Receives: Behavioral: Exercise intervention |
| Control group | No intervention | Subjects will not receive structured physical exercise guidance but are encouraged to engage in regular physical exercise. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6-Minute Walk Test Distance
Measured: Between baseline and 90 days
Secondary outcomes (9)
Proportion of patients with mRS score 0-1
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
Measured: 90 days and 1year
Physical Activity Scale for the Elderly (PASE) score
This test assesses physical activity, including leisure, household, and occupational activity. Score range: minimum 0 to maximum 400 or more. Higher score means a better outcome.
Measured: 90 days and 1year
Short Physical Performance Battery (SPPB) score
This test measures levels of lower extremity function. The SPPB ranges from 0 to 12, with higher scores indicating better outcomes.
Measured: 90 days and 1year
Mean daily step count
Measured: 90 days and 1year
Patient Health Questionnaire-9 (PHQ-9) score
This test screens for depression. The PHQ-9 ranges from 0 to 27, with higher scores indicating worse outcomes.
Measured: 90 days and 1year
Mini Montreal Cognitive Assessment score
This test measures levels of cognitive function. This test ranges from 0 to 15, with higher scores indicating better outcomes.
Measured: 90 days
Resting heart rate
Measured: 90 days
Resting blood pressure
Measured: 90 days
EQ-5D-5L and EQ-VAS
The EQ-5D-5L includes 5 dimensions: mobility, self-care, usual activities,pain/discomfort, and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Higher scores indicate worse quality of life.
Measured: 90 days and 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start18 Dec 2025
- Primary completion14 Aug 2026
- Study completion14 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 208 participants (actual)
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
- NCT07271082
- Sponsor's protocol ID
- HOPE-STROKE 2
- Acronym
- HOPE-STROKE 2
- Status last verified
- Sep 2026
- First submitted
- 27 Nov 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Related data will be shared if full study protocol and statistical analysis plan are provided with reasonable design.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Home-based Structured Physical Exercise in Patients With Acute Ischemic Stroke: a Randomized Controlled, Open-label, Blinded Endpoint Trial-2 (HOPE-STROKE 2)
- ClinicalTrials.gov ID
- NCT07271082
- Acronym / sponsor ID
- HOPE-STROKE 2 / HOPE-STROKE 2
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke, Physical Exercise
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- 14 Aug 2026 (actual)
- Study completion
- 14 Aug 2027 (estimated)
- First posted
- 8 Dec 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 is a randomized controlled, open-label, blinded endpoint trial. The investigators aim to assess the efficacy and safety of home-based structured physical exercise in participants with acute ischemic stroke.
Detailed description
The study population is participants with acute ischemic stroke within 14 days of onset. All participants are randomly assigned to the exercise intervention group or the control group in a 1:1 ratio. In the exercise intervention group, participants will undergo 90 days of home-based structured physical exercise guidance. The individualized exercise prescription will be determined based on each participant's overall condition. In the control group, participants will not receive structured physical exercise guidance but are encouraged to engage in regular physical exercise. Both groups of participants will receive standard medical management based on the latest guidelines from the American Heart Association/American Stroke Association.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise intervention group | Experimental | Behavioral: Exercise interventionHome-based structured physical exercise guidance. |
| Control group | No intervention | –Subjects will not receive structured physical exercise guidance but are encouraged to engage in regular physical exercise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or greater, male or female;
- Acute ischemic stroke onset within 14 days;
- modified Rankin scale (mRS) score ≤ 3;
- Signed informed consent from the patients or the legally authorized representatives.
Key exclusion criteria (10 listed)
- Stroke progression within the past 3 days (defined as an increase in NIHSS score of ≥4 points or an increase in any single item of ≥2 points);
- Concurrent osteoarthritis, fractures, deep vein thrombosis, unstable angina, severe heart diseases, respiratory diseases, or amputation that may theoretically make it difficult for participants to complete the physical exercise or ambulation;
- Concurrent movement disorders such as Parkinson's disease or Parkinsonism;
- Patients who have engaged in regular aerobic physical activity within the past 6 months, defined as more than 150 minutes of moderate-intensity aerobic physical activity; or more than 75 minutes of vigorous-intensity aerobic physical activity; or an equivalent combination of moderate- and vigorous-intensity activity throughout the week;
- Unable to comply with the study procedures or follow-up due to psychiatric, cognitive, or emotional disorders;
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 |
|---|---|---|
| Exercise interventionSubjects will undergo 90 days of home-based structured physical exercise guidance. | Behavioural | Exercise intervention group |
Primary outcome
Change in 6-Minute Walk Test Distance
Time frame: Between baseline and 90 days
9 secondary outcomes
Proportion of patients with mRS score 0-1
Time frame: 90 days and 1year
Physical Activity Scale for the Elderly (PASE) score
Time frame: 90 days and 1year
Short Physical Performance Battery (SPPB) score
Time frame: 90 days and 1year
Mean daily step count
Time frame: 90 days and 1year
Patient Health Questionnaire-9 (PHQ-9) score
Time frame: 90 days and 1year
Mini Montreal Cognitive Assessment score
Time frame: 90 days
Resting heart rate
Time frame: 90 days
Resting blood pressure
Time frame: 90 days
EQ-5D-5L and EQ-VAS
Time frame: 90 days and 1year
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 21 Sep 2026.
- Individual participant dataSharing planned: Yes. Related data will be shared if full study protocol and statistical analysis plan are provided with reasonable design.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise intervention in people with Acute Ischemic Stroke, run by Capital Medical University at 6 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?
The sponsor lists 4 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
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?
Change in 6-Minute Walk Test Distance (time frame: Between baseline and 90 days). 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 21 Sep 2026.