Cardiac Rehabilitation of Stroke Survivors (SRP-CROSS)

Hackensack Meridian Health

Status: Enrolling

Conditions: Cerebrovascular Accident; Stroke

Treatments: Other: Cardiac rehabilitation program

Study type: Interventional

Funder types: Other

Identifiers

NCT05651945

Pro2022-0785

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Cardiac rehabilitation group

Experimental group

Description:

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.

Treatment:

Other: Cardiac rehabilitation program

Standard of care

No Intervention group

Description:

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.