Cardiac Rehabilitation of Stroke Survivors (SRP-CROSS) (SRP-CROSS)

February 3, 2026 updated by: Hackensack Meridian Health

Stroke Recovery Program-Cardiac Rehabilitation of Stroke Survivors

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New Jersey
      • Edison, New Jersey, United States, 08820
        • Recruiting
        • Hackensack Meridian Health - JFK Johnson Rehabilitation Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of care
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.
Experimental: Cardiac rehabilitation group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-Minute Walk Test (6MWT)
Time Frame: 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.
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)
Time Frame: 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.
Change from Baseline (30 days post-stroke) to 120 days post-stroke.
AM-PAC - (Activity Measure for Post Acute Care)
Time Frame: Change from Baseline (30 days post-stroke) to 120 days post-stroke.
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)
Time Frame: 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.
Change from Baseline (30 days post-stroke) to 120 days post-stroke.
SS-QOL - (Stroke specific Quality of Life)
Time Frame: Change from Baseline (30 days post-stroke) to 120 days post-stroke
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)
Time Frame: 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.
Change from Baseline (30 days post-stroke) to 120 days post-stroke
All-cause hospital readmission
Time Frame: 1-year post-stroke
All-cause hospital readmission rates at 1-year post-stroke
1-year post-stroke
Recurrent stroke rate
Time Frame: 1-year post stroke
Recurrent stroke rates at 1-year post stroke
1-year post stroke
All-cause mortality rate
Time Frame: 1-year post stroke
All-cause mortality rates at 1-year post stroke
1-year post stroke
AM-PAC - (Activity Measure for Post Acute Care)
Time Frame: 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.
1-year post stroke
SS-QOL - (Stroke specific Quality of Life)
Time Frame: 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.
1-year post stroke
mRS - (Modified Rankin Scale)
Time Frame: 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.
Change from Baseline (30 days post stroke) to 120 days post stroke
Picture Your Plate (PYP)
Time Frame: 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.
Change from Baseline (30 days post stroke) to 120 days post stroke
10-Minute Walk Test (10MWT)
Time Frame: 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.
Change from Baseline (30 days post-stroke) to 120 days post-stroke.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hackensack Meridian Health

Collaborators

The Cardiovascular Institute of New Jersey at Rutgers Robert Wood Johnson Medical School

Investigators

  • Principal Investigator: Sara J Cuccurullo, MD, Hackensack Meridian Health - JFK Johnson Rehabilitation Institute
  • Principal Investigator: Talya K Fleming, MD, Hackensack Meridian Health - JFK Johnson Rehabilitation Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2023

Primary Completion (Estimated)

January 20, 2027

Study Completion (Estimated)

January 20, 2031

Study Registration Dates

First Submitted

December 7, 2022

First Submitted That Met QC Criteria

December 7, 2022

First Posted (Actual)

December 15, 2022

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro2022-0785

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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