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Completed

NCT Number: NCT03944668

Comprehensive Cardiac Rehabilitation Feasibility After Stroke

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HealthPartners Neuroscience Center, Saint Paul, Minnesota, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

36 sessions of comprehensive cardiac rehabilitation over 12 weeks

Primary outcomes

  1. Attendance Rate

    Time frame: 12 weeks

    75% attendance at comprehensive cardiovascular rehabilitation (CCR) sessions

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Registry information

Acronym: CCRFast

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 9, 2019
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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