Recruiting

Cardiac Rehabilitation

Sponsor:

Hackensack Meridian Health

Code:

NCT05651945

Conditions

Stroke

Cerebrovascular Accident

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cardiac rehabilitation program

Study Details

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.

Conditions

Stroke

Cerebrovascular Accident

Study ID

NCT05651945

Start date

Jan 20, 2023

Status verified date

Sep, 2026

Completion date

Jan 20, 2031

Anticipated

Primary completion date

Jan 20, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • 6-Minute Walk Test (6MWT) [ Time Frame: Change from Baseline (30 days post-stroke) to 120 days post-stroke. ]

Central Contacts and Locations

Central contacts

Hayk Petrosyan, Ph.D.

732-321-7000hayk.petrosyan@hmhn.org

Locations

Hackensack Meridian Health - JFK Johnson Rehabilitation Institute

Recruiting

Edison, New Jersey, United States, 08820

Contacts

Hayk Petrosyan, PhD

732-321-7000hayk.petrosyan@hmhn.org

More Information

Sponsor

Hackensack Meridian Health

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

  • cardiac rehabilitation
  • stroke
  • stroke rehabilitation
  • stroke recovery
  • exercise
  • cardiovascular disease
  • cardiovascular function
  • cognitive function
  • physical function
  • neurorehabilitation
  • transition of care post stroke

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hackensack Meridian Health on 2026-09-09.