Clinical trial NCT05651945: Cardiac Rehabilitation of Stroke Survivors (SRP-CROSS)
Official title: Stroke Recovery Program-Cardiac Rehabilitation of Stroke Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Cerebrovascular Accident
Keywords: cardiac rehabilitation
stroke
stroke rehabilitation
stroke recovery
exercise
cardiovascular disease
cardiovascular function
cognitive function
physical function
neurorehabilitation
transition of care post stroke
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
Collaborators: name: The Cardiovascular Institute of New Jersey at Rutgers Robert Wood Johnson Medical School
First posted: 2022-12-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 6-Minute Walk Test (6MWT)
timeFrame: Change from Baseline (30 days post-stroke) to 120 days post-stroke.
Secondary outcomes:
measure: MET-min - (Metabolic Equivalent of Task - minutes)
timeFrame: Change from Baseline (30 days post-stroke) to 120 days post-stroke.
measure: AM-PAC - (Activity Measure for Post Acute Care)
timeFrame: Change from Baseline (30 days post-stroke) to 120 days post-stroke.
measure: 10-Minute Walk Test (10MWT)
timeFrame: Change from Baseline (30 days post-stroke) to 120 days post-stroke.
measure: MoCA - (Montreal Cognitive Assessment)
timeFrame: Change from Baseline (30 days post-stroke) to 120 days post-stroke.
measure: SS-QOL - (Stroke specific Quality of Life)
timeFrame: Change from Baseline (30 days post-stroke) to 120 days post-stroke
measure: PHQ-9 - (Patient Health Questionnaire -9)
timeFrame: Change from Baseline (30 days post-stroke) to 120 days post-stroke
measure: All-cause hospital readmission
timeFrame: 1-year post-stroke
measure: Recurrent stroke rate
timeFrame: 1-year post stroke
measure: All-cause mortality rate
timeFrame: 1-year post stroke
measure: AM-PAC - (Activity Measure for Post Acute Care)
timeFrame: 1-year post stroke
measure: SS-QOL - (Stroke specific Quality of Life)
timeFrame: 1-year post stroke
measure: mRS - (Modified Rankin Scale)
timeFrame: Change from Baseline (30 days post stroke) to 120 days post stroke
measure: Picture Your Plate (PYP)
timeFrame: Change from Baseline (30 days post stroke) to 120 days post stroke
Other outcomes:
Locations:
city: Edison
country: United States
facility: Hackensack Meridian Health - JFK Johnson Rehabilitation Institute
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health - JFK Johnson Rehabilitation Institute
name: Sara J Cuccurullo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hackensack Meridian Health - JFK Johnson Rehabilitation Institute
name: Talya K Fleming, MD
role: PRINCIPAL_INVESTIGATOR
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