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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Comprehensive Cardiac Rehabilitation Feasibility After Stroke

Clinicaltrials.gov identifier NCT03944668

Recruitment Status Completed

First Posted May 9, 2019

Result First Posted February 24, 2021

Last update posted February 24, 2021

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:Stroke, Ischemic
  • Intervention/Treatment: Behavioral: Exercise
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 17 participants
  • 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 2019
  • Actual Primary Completion Date: December 2020
  • Actual Study Completion Date: December 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
  • 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
Contacts
Locations

United States, Minnesota
Regions Hospital
Saint Paul

United States, Minnesota
Regions Hospital Outpatient Cardiopulmonary Rehabilitation Clinic
Saint Paul

United States, Minnesota
HealthPartners Neuroscience Center
Saint Paul

Sponsors and Collaborators

HealthPartners Institute

Investigators

Principal Investigator: Haitham M Hussein, MD Regions Hospital Stroke Center

More Information
  • Responsible Party: HealthPartners Institute
  • ClinicalTrials.gov Identifier: NCT03944668 History of Changes
  • Other Study ID Numbers: 18-361
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: February 24, 2021
  • Last Verified: September 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Stroke
  • Study Type: Interventional
  • Study Design: Allocation: N/A;Intervention Model: Single Group Assignment;Masking: None (Open Label);Primary Purpose: Other
  • Condition: Stroke, Ischemic
  • Interventions : Behavioral: Exercise
  • Enrollment: 17
Participant flow
Recruitment Details 32 patients assessed for eligibility 9 refused to participate 6 unable to reach
Pre-assignment Details
Arm/Group title Intervention
Arm/Group Description Exercise intervention Exercise: 36 sessions of comprehensive cardiac rehabilitation over 12 weeks
Period Title: Overall Study
Started 17
Completed 8
Not Completed 9
Reason Not Completed
Baseline Characteristics
Arm/Group title Intervention
Arm/Group Description Exercise intervention Exercise: 36 sessions of comprehensive cardiac rehabilitation over 12 weeks
Overall Number of Baseline Participants 14
Baseline Analysis Population Description 14 Enrolled and consented stroke patients
Region of Enrollment Measure Type: Number Unit of Measure: Participants Number Analyzed 14 Participants
Outcome Measures
1. PrimaryOutcome
Title Attendance Rate
Description 75% attendance at comprehensive cardiovascular rehabilitation (CCR) sessions
Time Frame 12 weeks
Outcome Measure Data
Analysis Population Description
14 Stroke patients who enrolled and consented in study
 
Arm/Group title Intervention
Arm/Group Description Exercise intervention Exercise: 36 sessions of comprehensive cardiac rehabilitation over 12 weeks
Overall Number of Participants Analyzed 14
Measure Type: Count of Participants
Unit of Measure: Participants
8
2. SecondaryOutcome
Title Number of Participants Without Death
Description rate
Time Frame 6 month
Outcome Measure Data
Analysis Population Description
14 Stroke patients who enrolled and consented in study
 
Arm/Group title Intervention
Arm/Group Description Stroke patients enrolled in study
Overall Number of Participants Analyzed 14
Measure Type: Count of Participants
Unit of Measure: Participants
6
8
3. SecondaryOutcome
Title Number of Participants With or Without Silent Stroke
Description rate, on MRI
Time Frame 6 month
Outcome Measure Data
Analysis Population Description
14 Stroke patients who enrolled and consented in study
 
Arm/Group title Intervention
Arm/Group Description Stroke patients enrolled in study
Overall Number of Participants Analyzed 14
Measure Type: Count of Participants
Unit of Measure: Participants
6
7
1
4. SecondaryOutcome
Title Hospital Readmission
Description rate, for a cardiovascular or cerebrovascular indication
Time Frame 6 month
Outcome Measure Data
Analysis Population Description
14 Stroke patients who enrolled and consented in study
 
Arm/Group title Intervention
Arm/Group Description Stroke patients enrolled in study
Overall Number of Participants Analyzed 14
Measure Type: Count of Participants
Unit of Measure: Participants
6
8
5. SecondaryOutcome
Title Number of Participants With or Without Myocardial Infarction
Description Myocardial infarction in follow-up time
Time Frame 6 month
Outcome Measure Data
Analysis Population Description
14 Stroke patients who enrolled and consented in study
 
Arm/Group title Intervention
Arm/Group Description Stroke patients enrolled in study
Overall Number of Participants Analyzed 14
Measure Type: Count of Participants
Unit of Measure: Participants
6
8
6. SecondaryOutcome
Title Number of Patients With or Without Recurrent Stroke
Description Recurrent stroke in follow-up period
Time Frame 6 month
Outcome Measure Data
Analysis Population Description
14 Stroke patients who enrolled and consented in study
 
Arm/Group title Intervention
Arm/Group Description Stroke patients enrolled in study
Overall Number of Participants Analyzed 14
Measure Type: Count of Participants
Unit of Measure: Participants
6
8
Adverse Events
Time Frame
Adverse Event Reporting Description
 
Arm/Group Title
Arm/Group Description
Limitations and Caveats

[Not Specified]

More Information
Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact
  • ClinicalTrials.gov Identifier: NCT03944668 History of Changes
  • Other Study ID Numbers: 18-361
  • First Submitted: May 8, 2019
  • First Posted: May 9, 2019
  • Results First Submitted: January 19, 2021
  • Results First Posted: February 24, 2021
  • Last Update Posted: February 24, 2021