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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
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.
Hackensack Meridian Health - JFK Johnson Rehabilitation Institute
Edison, New Jersey, United States
RECRUITING6-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.
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.
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.
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.
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.
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.
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Time frame: 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.
Time frame: 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
Time frame: 1-year post-stroke
Recurrent stroke rate
Recurrent stroke rates at 1-year post stroke
Time frame: 1-year post stroke
All-cause mortality rate
All-cause mortality rates at 1-year post stroke
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from Baseline (30 days post stroke) to 120 days post stroke