Comprehensive Cardiac Rehabilitation Feasibility After Stroke

NCT ID: NCT03944668

Last Updated: 2023-05-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-29

Study Completion Date

2020-12-31

Brief Summary

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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

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Conditions

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Stroke, Ischemic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

single arm, non-randomized
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention

Exercise intervention

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

36 sessions of comprehensive cardiac rehabilitation over 12 weeks

Interventions

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Exercise

36 sessions of comprehensive cardiac rehabilitation over 12 weeks

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HealthPartners Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Haitham M Hussein, MD

Role: PRINCIPAL_INVESTIGATOR

Regions Hospital Stroke Center

Locations

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Regions Hospital

Saint Paul, Minnesota, United States

Site Status

Regions Hospital Outpatient Cardiopulmonary Rehabilitation Clinic

Saint Paul, Minnesota, United States

Site Status

HealthPartners Neuroscience Center

Saint Paul, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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18-361

Identifier Type: -

Identifier Source: org_study_id

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