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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03944668
Other study ID # 18-361
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 29, 2019
Est. completion date December 31, 2020

Study information

Verified date September 2020
Source HealthPartners Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Exercise
36 sessions of comprehensive cardiac rehabilitation over 12 weeks

Locations

Country Name City State
United States HealthPartners Neuroscience Center Saint Paul Minnesota
United States Regions Hospital Saint Paul Minnesota
United States Regions Hospital Outpatient Cardiopulmonary Rehabilitation Clinic Saint Paul Minnesota

Sponsors (1)

Lead Sponsor Collaborator
HealthPartners Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Attendance Rate 75% attendance at comprehensive cardiovascular rehabilitation (CCR) sessions 12 weeks
Secondary Number of Patients With or Without Recurrent Stroke Recurrent stroke in follow-up period 6 month
Secondary Number of Participants With or Without Myocardial Infarction Myocardial infarction in follow-up time 6 month
Secondary Hospital Readmission rate, for a cardiovascular or cerebrovascular indication 6 month
Secondary Number of Participants With or Without Silent Stroke rate, on MRI 6 month
Secondary Number of Participants Without Death rate 6 month
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