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Comprehensive Cardiac Rehabilitation Feasibility After Stroke (CCRFast)

Primary Purpose

Stroke, Ischemic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
HealthPartners Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke, Ischemic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Regions Hospital
  • Regions Hospital Outpatient Cardiopulmonary Rehabilitation Clinic
  • HealthPartners Neuroscience Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Exercise intervention

Outcomes

Primary Outcome Measures

Attendance Rate
75% attendance at comprehensive cardiovascular rehabilitation (CCR) sessions

Secondary Outcome Measures

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

Full Information

First Posted
May 8, 2019
Last Updated
May 11, 2023
Sponsor
HealthPartners Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03944668
Brief Title
Comprehensive Cardiac Rehabilitation Feasibility After Stroke
Acronym
CCRFast
Official Title
Comprehensive Cardiac Rehabilitation Feasibility After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 29, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HealthPartners Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single arm, non-randomized
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Exercise intervention
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
36 sessions of comprehensive cardiac rehabilitation over 12 weeks
Primary Outcome Measure Information:
Title
Attendance Rate
Description
75% attendance at comprehensive cardiovascular rehabilitation (CCR) sessions
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of Patients With or Without Recurrent Stroke
Description
Recurrent stroke in follow-up period
Time Frame
6 month
Title
Number of Participants With or Without Myocardial Infarction
Description
Myocardial infarction in follow-up time
Time Frame
6 month
Title
Hospital Readmission
Description
rate, for a cardiovascular or cerebrovascular indication
Time Frame
6 month
Title
Number of Participants With or Without Silent Stroke
Description
rate, on MRI
Time Frame
6 month
Title
Number of Participants Without Death
Description
rate
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haitham M Hussein, MD
Organizational Affiliation
Regions Hospital Stroke Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regions Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
Regions Hospital Outpatient Cardiopulmonary Rehabilitation Clinic
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States
Facility Name
HealthPartners Neuroscience Center
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55130
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Comprehensive Cardiac Rehabilitation Feasibility After Stroke

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