Cardiac Rehabilitation of Stroke Survivors (SRP-CROSS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHackensack Meridian Health
About this trial
This study examines the effectiveness of the cardiac rehabilitation program for stroke patients. The study will examine if patients with stroke, who receive cardiac rehabilitation in addition to their standard of care treatments, demonstrate improved recovery of function. It will also examine if these patients have reduced hospital readmission, reduced rate of recurrent stroke, and mortality.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older
Stroke diagnosis (ischemic or hemorrhagic) / radiologic evidence of acute stroke
Medically cleared by a cardiologist for participation in the cardiac rehabilitation program with no contraindications to cardiac rehabilitation per American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) guidelines
Ability to transfer on/off the recumbent bike with or without an assistive device safely, with or without assistance from another person
Disqualifiers
Presence of subarachnoid hemorrhage, intracranial aneurysm, intracranial hemangioma, or arteriovenous malformation
Medical disorders that preclude participation in the study as determined by the Principal Investigator.
Inability to have baseline assessment within 60 days post-stroke diagnosis
Patient considered unable to comply with study requirements
Trial design
Design model
Parallel
Treatments tested in this trial
Cardiac rehabilitation program
Other interventionThe cardiac rehabilitation program is an outpatient exercise intervention consisting of 36 sessions (30-50 minutes) of a progressive exercise program. Participants are closely monitored throughout the sessions using a telemetry monitor and are supervised by a team of cardiac rehabilitation nurses and exercise physiologists. In addition to the exercise program, participants will receive educational sessions for cardiovascular disease (CVD) risk factors including: 1) Diet/Nutrition, 2) Smoking cessation, 3) Physical activity, 4) Medication management/adherence and 5) Behavior change. As a part of the program, based on the initial assessment results, patients are referred to a rehabilitation psychologist or a dietician for consultation and evaluation if needed. In addition, participants will also receive their standard of care therapies as prescribed by their treating physicians.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Cardiac rehabilitation groupExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
6-Minute Walk Test (6MWT)
Mean change in 6MWT score from baseline (30 days post-stroke) to 120 days post-stroke.
Time frame
Change from Baseline (30 days post-stroke) to 120 days post-stroke.Secondary outcomes
1
MET-min - (Metabolic Equivalent of Task - minutes)
Mean change in MET-min score from baseline (30 days post-stroke) to 120 days post-stroke.
Time frame
Change from Baseline (30 days post-stroke) to 120 days post-stroke.2
AM-PAC - (Activity Measure for Post Acute Care)
Mean change in AM-PAC score from baseline (30 days post-stroke) to 120 days post-stroke. AM-PAC is a questionnaire that evaluates functional outcomes across three domains: basic mobility, daily activity, and applied cognitive. Standardized scores range from -11.95 to 104.9 for basic mobility, from -2.73 to 115.4 for daily activities, and from 6.84 to 68.28 for applied cognition with higher scores representing a better function.
Time frame
Change from Baseline (30 days post-stroke) to 120 days post-stroke.3
10-Minute Walk Test (10MWT)
Mean change in 10MWT score from baseline (30 days post-stroke) to 120 days post-stroke.
Time frame
Change from Baseline (30 days post-stroke) to 120 days post-stroke.4
MoCA - (Montreal Cognitive Assessment)
Mean change in MoCA score from baseline (30 days post-stroke) to 120 days post-stroke. MoCA is a 16-item test assessing multiple cognitive domains with a score range from 0-30 with higher scores representing a better function.
Time frame
Change from Baseline (30 days post-stroke) to 120 days post-stroke.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hackensack Meridian Health
Lead sponsor
The Cardiovascular Institute of New Jersey at Rutgers Robert Wood Johnson Medical School
Collaborator
Source ClinicalTrials.gov