Comprehensive Cardiac Rehabilitation Feasibility After Stroke (CCRFast)

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 Overview

• Status: Completed
• Conditions: Stroke, Ischemic
• Intervention / Treatment: Behavioral: Exercise

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Saint Paul, Minnesota, United States, 55101
      • Regions Hospital
    • Saint Paul, Minnesota, United States, 55130
      • HealthPartners Neuroscience Center
    • Saint Paul, Minnesota, United States, 55114
      • Regions Hospital Outpatient Cardiopulmonary Rehabilitation Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Exercise intervention	Behavioral: Exercise; 36 sessions of comprehensive cardiac rehabilitation over 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attendance Rate	75% attendance at comprehensive cardiovascular rehabilitation (CCR) sessions	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With or Without Recurrent Stroke	Recurrent stroke in follow-up period	6 month
Number of Participants With or Without Myocardial Infarction	Myocardial infarction in follow-up time	6 month
Hospital Readmission	rate, for a cardiovascular or cerebrovascular indication	6 month
Number of Participants With or Without Silent Stroke	rate, on MRI	6 month
Number of Participants Without Death	rate	6 month

Collaborators and Investigators

• Sponsor: HealthPartners Institute
• Investigators: Principal Investigator: Haitham M Hussein, MD, Regions Hospital Stroke Center

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: May 8, 2019
• First Submitted That Met QC Criteria: May 8, 2019
• First Posted (Actual): May 9, 2019

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: 18-361

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No