NCT03944668

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 29, 2019

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 9, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
2 months until next milestone

Results Posted

Study results publicly available

February 24, 2021

Completed
Last Updated

May 16, 2023

Status Verified

September 1, 2020

Enrollment Period

1.7 years

First QC Date

May 8, 2019

Results QC Date

January 19, 2021

Last Update Submit

May 11, 2023

Conditions

Stroke, Ischemic

Outcome Measures

Primary Outcomes (1)

  • Attendance Rate

    75% attendance at comprehensive cardiovascular rehabilitation (CCR) sessions

    12 weeks

Secondary Outcomes (5)

  • Number of Patients With or Without Recurrent Stroke

    6 month

  • Number of Participants With or Without Myocardial Infarction

    6 month

  • Hospital Readmission

    6 month

  • Number of Participants With or Without Silent Stroke

    6 month

  • Number of Participants Without Death

    6 month

Study Arms (1)

Intervention

EXPERIMENTAL

Exercise intervention

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

36 sessions of comprehensive cardiac rehabilitation over 12 weeks

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Regions Hospital Outpatient Cardiopulmonary Rehabilitation Clinic

Saint Paul, Minnesota, 55114, United States

Location

HealthPartners Neuroscience Center

Saint Paul, Minnesota, 55130, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Exercise

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Amanda Herrmann, PhD
Organization
HealthPartners Neuroscience Research
amanda.a.herrmann@healthpartners.com
651-495-6356

Study Officials

  • Haitham M Hussein, MD

    Regions Hospital Stroke Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: single arm, non-randomized
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2019

First Posted

May 9, 2019

Study Start

April 29, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

May 16, 2023

Results First Posted

February 24, 2021

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(3)