Clinical trial NCT03944668: Comprehensive Cardiac Rehabilitation Feasibility After Stroke
Official title: Comprehensive Cardiac Rehabilitation Feasibility After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Ischemic
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single arm, non-randomized
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Attendance Rate
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of Patients With or Without Recurrent Stroke
timeFrame: 6 month
measure: Number of Participants With or Without Myocardial Infarction
timeFrame: 6 month
measure: Hospital Readmission
timeFrame: 6 month
measure: Number of Participants With or Without Silent Stroke
timeFrame: 6 month
measure: Number of Participants Without Death
timeFrame: 6 month
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Saint Paul
country: United States
facility: Regions Hospital Outpatient Cardiopulmonary Rehabilitation Clinic
state: Minnesota
city: Saint Paul
country: United States
facility: HealthPartners Neuroscience Center
state: Minnesota
Study officials:
affiliation: Regions Hospital Stroke Center
name: Haitham M Hussein, MD
role: PRINCIPAL_INVESTIGATOR
References: