Cardiac Rehabilitation of Stroke Survivors (SRP-CROSS)

Not Applicable

Recruiting

• Conditions: Stroke; Cerebrovascular Accident
• Interventions: Other: Cardiac rehabilitation program

• Registration Number: NCT05651945
• Lead Sponsor: Hackensack Meridian Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-07
• Study First Submitted QC: 2022-12-07
• Study First Posted: 2022-12-15
• Study Start: 2023-01-20
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-09
• Primary Completion: 2026-01-20
• Study Completion: 2031-01-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 112

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cardiac rehabilitation group	Cardiac rehabilitation program	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 mortality rate	1-year post stroke	All-cause mortality rates at 1-year post stroke
AM-PAC - (Activity Measure for Post Acute Care)	1-year post stroke	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.
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.
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.
SS-QOL - (Stroke specific Quality of Life)	1-year post stroke	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.
All-cause hospital readmission	1-year post-stroke	All-cause hospital readmission rates at 1-year post-stroke
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.
Recurrent stroke rate	1-year post stroke	Recurrent stroke rates at 1-year post stroke
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.

Trial Locations

Locations (1)

Hackensack Meridian Health - JFK Johnson Rehabilitation Institute; 🇺🇸 Edison, New Jersey, United States