Comprehensive Cardiac Rehabilitation Feasibility After Stroke

Stroke, Ischemic Clinical Trial

— CCRFast  

Official title:

Comprehensive Cardiac Rehabilitation Feasibility After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03944668
• Other study ID #: 18-361
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke
• Stroke, Ischemic

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