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NCT Number: NCT05651945

Cardiac Rehabilitation of Stroke Survivors (SRP-CROSS)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hackensack Meridian Health - JFK Johnson Rehabilitation Institute

Edison, New Jersey, 08820, United States

Location status: Recruiting

Location contact

Hayk Petrosyan, PhD

CONTACT

[email protected]

732-321-7000 ext. 65979

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac rehabilitation program

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. All-cause hospital readmission

    Time frame: 1-year post-stroke

    All-cause hospital readmission rates at 1-year post-stroke

  8. Recurrent stroke rate

    Time frame: 1-year post stroke

    Recurrent stroke rates at 1-year post stroke

  9. All-cause mortality rate

    Time frame: 1-year post stroke

    All-cause mortality rates at 1-year post stroke

  10. 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.

  11. 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.

  12. 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.

  13. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hayk Petrosyan, Ph.D.

CONTACT

[email protected]

732-321-7000 ext. 65979

Sponsors and collaborators

Lead sponsor

Hackensack Meridian Health

Other

Collaborators

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

Registry information

Official study title

Stroke Recovery Program-Cardiac Rehabilitation of Stroke Survivors

Acronym: SRP-CROSS

Important dates

Study start
2023
Primary completion
2027
Study completion
2031
First posted
Dec 15, 2022
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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