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出境医 / 临床实验 / Comprehensive Cardiac Rehabilitation Feasibility After Stroke (CCRFast)

Comprehensive Cardiac Rehabilitation Feasibility After Stroke (CCRFast)

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.

Condition or disease Intervention/treatment Phase
Stroke, Ischemic Behavioral: Exercise Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: single arm, non-randomized
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Comprehensive Cardiac Rehabilitation Feasibility After Stroke
Actual Study Start Date : April 29, 2019
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : December 31, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Intervention
Exercise intervention
 Behavioral: Exercise
36 sessions of comprehensive cardiac rehabilitation over 12 weeks
Outcome Measures
Primary Outcome Measures :
  1. Attendance Rate [ Time Frame: 12 weeks ]
    75% attendance at comprehensive cardiovascular rehabilitation (CCR) sessions


Secondary Outcome Measures :
  1. Number of Patients With or Without Recurrent Stroke [ Time Frame: 6 month ]
    Recurrent stroke in follow-up period

  2. Number of Participants With or Without Myocardial Infarction [ Time Frame: 6 month ]
    Myocardial infarction in follow-up time

  3. Hospital Readmission [ Time Frame: 6 month ]
    rate, for a cardiovascular or cerebrovascular indication

  4. Number of Participants With or Without Silent Stroke [ Time Frame: 6 month ]
    rate, on MRI

  5. Number of Participants Without Death [ Time Frame: 6 month ]
    rate


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
Layout table for location information
United States, Minnesota
Regions Hospital
Saint Paul, Minnesota, United States, 55101
Regions Hospital Outpatient Cardiopulmonary Rehabilitation Clinic
Saint Paul, Minnesota, United States, 55114
HealthPartners Neuroscience Center
Saint Paul, Minnesota, United States, 55130
Sponsors and Collaborators
HealthPartners Institute
Investigators
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Principal Investigator: Haitham M Hussein, MD Regions Hospital Stroke Center
Tracking Information
First Submitted Date  ICMJE May 8, 2019
First Posted Date  ICMJE May 9, 2019
Results First Submitted Date  ICMJE January 19, 2021
Results First Posted Date  ICMJE February 24, 2021
Last Update Posted Date February 24, 2021
Actual Study Start Date  ICMJE April 29, 2019
Actual Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2021) 		Attendance Rate [ Time Frame: 12 weeks ]
75% attendance at comprehensive cardiovascular rehabilitation (CCR) sessions
Original Primary Outcome Measures  ICMJE
 (submitted: May 8, 2019) 		Attendance Rate [ Time Frame: 12 weeks ]
75% attendance at CCR (comprehensive cardiovascular rehabilitation) sessions
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2021)
  • Number of Patients With or Without Recurrent Stroke [ Time Frame: 6 month ]
    Recurrent stroke in follow-up period
  • Number of Participants With or Without Myocardial Infarction [ Time Frame: 6 month ]
    Myocardial infarction in follow-up time
  • Hospital Readmission [ Time Frame: 6 month ]
    rate, for a cardiovascular or cerebrovascular indication
  • Number of Participants With or Without Silent Stroke [ Time Frame: 6 month ]
    rate, on MRI
  • Number of Participants Without Death [ Time Frame: 6 month ]
    rate
Original Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2019)
  • Recurrent stroke [ Time Frame: 6 month ]
    rate
  • Myocardial infarction [ Time Frame: 6 month ]
    rate
  • Hospital Readmission [ Time Frame: 6 month ]
    rate, for a cardiovascular or cerebrovascular indication
  • silent stroke [ Time Frame: 6 month ]
    rate, on MRI
  • death [ Time Frame: 6 month ]
    rate
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comprehensive Cardiac Rehabilitation Feasibility After Stroke
Official Title  ICMJE Comprehensive Cardiac Rehabilitation Feasibility After Stroke
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
single arm, non-randomized
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Stroke, Ischemic
Intervention  ICMJE Behavioral: Exercise
36 sessions of comprehensive cardiac rehabilitation over 12 weeks
Study Arms  ICMJE Experimental: Intervention
Exercise intervention
Intervention: Behavioral: Exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2021) 		17
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2019) 		15
Actual Study Completion Date  ICMJE December 31, 2020
Actual Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03944668
Other Study ID Numbers  ICMJE 18-361
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party HealthPartners Institute
Study Sponsor  ICMJE HealthPartners Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Haitham M Hussein, MD Regions Hospital Stroke Center
PRS Account HealthPartners Institute
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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