Stroke, IschemicCCRFastNCT03944668
Comprehensive Cardiac Rehabilitation Feasibility After Stroke
A study testing Exercise in people with Stroke, Ischemic, run by HealthPartners Institute at 3 sites in United States.
Trial summary
Comprehensive Cardiovascular Rehabilitation Feasibility After Stroke (CCR FAST) will evaluate the feasibility of enrolling Regions Hospital stroke patients in a Comprehensive Cardiovascular Rehabilitation (CCR) program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Apr 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient has suffered an ischemic stroke
- Patient should be ambulatory (non-disabling stroke) to be able to participate in the CCR exercise program
- Patient is able to start cardiac rehabilitation within 2 weeks of stroke
Who cannot join
- No baseline (index admission for ischemic stroke) MRI completed
- Life expectancy < 1-year
- Presence of brain hemorrhage: intracerebral hemorrhage, subarachnoid hemorrhage, subdural hematoma, or epidural hematoma
- Concurrent diagnosis of seizure disorder
- Patient with moderate or severe neurologic deficits, limiting their ability to participate in the CCR exercise program
- Cardiopulmonary conditions preventing the patient from participation, such as severe heart failure, severe aortic stenosis, and exercise-induced asthma
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- Patient with cognitive dysfunction impairing their ability to follow directions
- Anticipated procedures such as carotid stenting, carotid endarterectomy, and intracranial aneurysm coiling
- Patient unable to commit to the frequent visits of the CCR program
- Participation in other interventional research (observational research is allowed)
- Unable to have brain MRI
- Non-English speaker
- Pregnant women
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Regions Hospital
Saint Paul, Minnesota, 55101
Regions Hospital Outpatient Cardiopulmonary Rehabilitation Clinic
Saint Paul, Minnesota, 55114
HealthPartners Neuroscience Center
Saint Paul, Minnesota, 55130
About this study
Comprehensive Cardiovascular Rehabilitation Feasibility After Stroke (CCR FAST) will evaluate the feasibility of enrolling Regions Hospital stroke patients in a Comprehensive Cardiovascular Rehabilitation (CCR) program. CCR will include aerobic exercise and patient education (regarding risk factors and medication compliance), similar to the rehabilitation program for cardiac disease patients. The overall goal of CCR FAST is to demonstrate the feasibility and safety of including stroke patients in a CCR program, while examining the clinical value in reducing stroke recurrence, myocardial infarction, readmission, and mortality in stroke patients.
- Conditions
- Stroke, Ischemic
- Being tested
- Exercise
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
36 sessions of comprehensive cardiac rehabilitation over 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Exercise intervention Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance Rate
75% attendance at comprehensive cardiovascular rehabilitation (CCR) sessions
Measured: 12 weeks
Secondary outcomes (5)
Number of Patients With or Without Recurrent Stroke
Recurrent stroke in follow-up period
Measured: 6 month
Number of Participants With or Without Myocardial Infarction
Myocardial infarction in follow-up time
Measured: 6 month
Hospital Readmission
rate, for a cardiovascular or cerebrovascular indication
Measured: 6 month
Number of Participants With or Without Silent Stroke
rate, on MRI
Measured: 6 month
Number of Participants Without Death
rate
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start29 Apr 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single arm, non-randomized
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haitham M Hussein, MD, Principal investigator, Regions Hospital Stroke Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03944668
- Sponsor's protocol ID
- 18-361
- Acronym
- CCRFast
- Status last verified
- Sep 2020
- First submitted
- 8 May 2019
- Last updated
- 16 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Cardiac Rehabilitation Feasibility After Stroke
- ClinicalTrials.gov ID
- NCT03944668
- Acronym / sponsor ID
- CCRFast / 18-361
- Conditions
- Stroke, Ischemic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 9 May 2019 (actual)
- Results
- Posted 24 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comprehensive Cardiovascular Rehabilitation Feasibility After Stroke (CCR FAST) will evaluate the feasibility of enrolling Regions Hospital stroke patients in a Comprehensive Cardiovascular Rehabilitation (CCR) program. CCR will include aerobic exercise and patient education (regarding risk factors and medication compliance), similar to the rehabilitation program for cardiac disease patients. The overall goal of CCR FAST is to demonstrate the feasibility and safety of including stroke patients in a CCR program, while examining the clinical value in reducing stroke recurrence, myocardial infarction, readmission, and mortality in stroke patients.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single arm, non-randomized
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: ExerciseExercise intervention |
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
- Patient has suffered an ischemic stroke
- Patient should be ambulatory (non-disabling stroke) to be able to participate in the CCR exercise program
- Patient is able to start cardiac rehabilitation within 2 weeks of stroke
Key exclusion criteria (13 listed)
- No baseline (index admission for ischemic stroke) MRI completed
- Life expectancy < 1-year
- Presence of brain hemorrhage: intracerebral hemorrhage, subarachnoid hemorrhage, subdural hematoma, or epidural hematoma
- Concurrent diagnosis of seizure disorder
- Patient with moderate or severe neurologic deficits, limiting their ability to participate in the CCR exercise program
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 |
|---|---|---|
| Exercise36 sessions of comprehensive cardiac rehabilitation over 12 weeks | Behavioural | Intervention |
Primary outcome
Attendance Rate
Time frame: 12 weeks
75% attendance at comprehensive cardiovascular rehabilitation (CCR) sessions
5 secondary outcomes
Number of Patients With or Without Recurrent Stroke
Time frame: 6 month
Number of Participants With or Without Myocardial Infarction
Time frame: 6 month
Hospital Readmission
Time frame: 6 month
Number of Participants With or Without Silent Stroke
Time frame: 6 month
Number of Participants Without Death
Time frame: 6 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Haitham M Hussein, MD principal investigator
Regions Hospital Stroke Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Stroke, Ischemic, run by HealthPartners Institute at 3 sites in United States.
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 13 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: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Yes. Results are posted in the registry (first posted 24 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Attendance Rate (time frame: 12 weeks). 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 16 May 2023.