Cardiac Rehabilitation of Stroke Survivors (SRP-CROSS)

Study Overview
=================
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.

Official Title
-----------------
Stroke Recovery Program-Cardiac Rehabilitation of Stroke Survivors

Conditions
-----------------
Stroke, Cerebrovascular Accident

Intervention / Treatment
-----------------
* Other: Cardiac rehabilitation program


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiac rehabilitation group<br>Traditional medically supervised center-based cardiac rehabilitation program; including 36 sessions (30-50 minutes) of a progressive exercise program and educational sessions for cardiovascular disease (CVD) risk factors. | Other: Cardiac rehabilitation program<br>* 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.<br>|
| No Intervention: Standard of care<br>Depending on functional deficits, conventional rehabilitation therapies can include physical therapy, occupational therapy, and/or speech therapy sessions with 2-3 visits per week. Participants will receive their standard of care therapies as prescribed by their treating physicians. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-Minute Walk Test (6MWT) | Mean change in 6MWT score from baseline (30 days post-stroke) to 120 days post-stroke. | Change from Baseline (30 days post-stroke) to 120 days post-stroke. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MET-min - (Metabolic Equivalent of Task - minutes) | Mean change in MET-min score from baseline (30 days post-stroke) to 120 days post-stroke. | Change from Baseline (30 days post-stroke) to 120 days post-stroke. | 
| 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. | Change from Baseline (30 days post-stroke) to 120 days post-stroke. | 
| 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. | Change from Baseline (30 days post-stroke) to 120 days post-stroke. | 
| SS-QOL - (Stroke specific Quality of Life) | 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. | Change from Baseline (30 days post-stroke) to 120 days post-stroke | 
| PHQ-9 - (Patient Health Questionnaire -9) | 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. | Change from Baseline (30 days post-stroke) to 120 days post-stroke | 
| All-cause hospital readmission | All-cause hospital readmission rates at 1-year post-stroke | 1-year post-stroke | 
| Recurrent stroke rate | Recurrent stroke rates at 1-year post stroke | 1-year post stroke | 
| All-cause mortality rate | All-cause mortality rates at 1-year post stroke | 1-year post stroke | 
| AM-PAC - (Activity Measure for Post Acute Care) | Mean change in AM-PAC score from baseline (30 days post stroke) to 1-year 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. | 1-year post stroke | 
| SS-QOL - (Stroke specific Quality of Life) | Mean change in SS-QOL score from baseline (30 days post stroke) to 1-year 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. | 1-year post stroke | 
| mRS - (Modified Rankin Scale) | 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. | Change from Baseline (30 days post stroke) to 120 days post stroke | 
| Picture Your Plate (PYP) | 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. | Change from Baseline (30 days post stroke) to 120 days post stroke | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac rehabilitation, stroke, stroke rehabilitation, stroke recovery, exercise, cardiovascular disease, cardiovascular function, cognitive function, physical function, neurorehabilitation, transition of care post stroke