Stroke, Cerebrovascular Accident
Conditions
Keywords
cardiac rehabilitation, stroke, stroke rehabilitation, stroke recovery, exercise, cardiovascular disease, cardiovascular function, cognitive function, physical function, neurorehabilitation, transition of care post stroke
Brief summary
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.
Interventions
The 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.
Sponsors
Hackensack Meridian Health
The Cardiovascular Institute of New Jersey at Rutgers Robert Wood Johnson Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Ability to follow simple commands and communicate pain or distress * Admission to an Inpatient Rehabilitation Facility post-stroke * Signed informed consent form
Exclusion criteria
* 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 * Known terminal illness with life expectancy less than 1 year * Compliant diagnosis eligible for traditional cardiac rehabilitation covered by insurance * Unable to understand/speak English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-Minute Walk Test (6MWT) | Change from Baseline (30 days post-stroke) to 120 days post-stroke. | Mean change in 6MWT score from baseline (30 days post-stroke) to 120 days post-stroke. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MET-min - (Metabolic Equivalent of Task - minutes) | Change from Baseline (30 days post-stroke) to 120 days post-stroke. | Mean change in MET-min score from baseline (30 days post-stroke) to 120 days post-stroke. |
| AM-PAC - (Activity Measure for Post Acute Care) | Change from Baseline (30 days post-stroke) to 120 days post-stroke. | 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. |
| 10-Minute Walk Test (10MWT) | Change from Baseline (30 days post-stroke) to 120 days post-stroke. | Mean change in 10MWT score from baseline (30 days post-stroke) to 120 days post-stroke. |
| MoCA - (Montreal Cognitive Assessment) | Change from Baseline (30 days post-stroke) to 120 days post-stroke. | 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. |
| SS-QOL - (Stroke specific Quality of Life) | Change from Baseline (30 days post-stroke) to 120 days post-stroke | Mean change in SS-QOL score from baseline (30 days post-stroke) to 120 days post-stroke. SS-QOL is a self-reported questionnaire containing 49 item questions covering 12 domains with a score range of 49-245 with higher scores representing better function. |
| PHQ-9 - (Patient Health Questionnaire -9) | Change from Baseline (30 days post-stroke) to 120 days post-stroke | Mean change in PHQ-9 score from baseline (30 days post-stroke) to 120 days post-stroke. The PHQ-9 is a self-administered questionnaire designed to diagnose and evaluate depression with a score range 0-27. |
| All-cause hospital readmission | 1-year post-stroke | All-cause hospital readmission rates at 1-year post-stroke |
| Recurrent stroke rate | 1-year post stroke | Recurrent stroke rates at 1-year post stroke |
| All-cause mortality rate | 1-year post stroke | All-cause mortality rates at 1-year post stroke |
| mRS - (Modified Rankin Scale) | Change from Baseline (30 days post stroke) to 120 days post stroke | Mean change in mRS score from baseline (30 days post stroke) to 120 days post stroke. The mRS is a questionnaire to assess the level of disability and functional independence in daily activities with reference to pre-stroke activities. The scale is scored 0-6 where 0 indicates lack of symptoms and the score 6 indicates death. |
| Picture Your Plate (PYP) | Change from Baseline (30 days post stroke) to 120 days post stroke | Mean change in PYP score from baseline (30 days post stroke) to 120 days post stroke. Picture Your Plate is a brief 48-question dietary assessment questionnaire with a total score ranging from 0 to 96 with higher scores representing an unhealthy diet. |
Countries
United States
Contacts
CONTACTHayk Petrosyan, Ph.D.
PRINCIPAL_INVESTIGATORSara J Cuccurullo, MD
Hackensack Meridian Health - JFK Johnson Rehabilitation Institute
PRINCIPAL_INVESTIGATORTalya K Fleming, MD
Hackensack Meridian Health - JFK Johnson Rehabilitation Institute
Outcome results
None listed