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Completed

NCT Number: NCT05201976

Effect of a Virtually Implemented Cardiac Rehabilitation Program

A clinical trial investigating the effects of a virtually implemented home-based cardiac rehab program with real-time, video based exercise supervision and vitals monitoring.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19054, United States

About this study

This study will use a randomized, controlled trial design to test the effectiveness of a virtually implemented cardiac rehabilitation (CR) program with real-time, video based supervised exercise and vitals monitoring as compared to traditional center based rehab in patients with a clinical indication for cardiac rehab. The primary outcome of effectiveness will be change in cardiorespiratory fitness as assessed by maximal VO2 achieved at the start of CR and on upon completion of CR.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who have been prescribed cardiac rehabilitation as part of their standard of care

Exclusion criteria

  • Patients with significant exercise limitations other than cardiovascular disease
  • Patients who are unable to exercise in home
  • Patients with active cancer treatment
  • Patients who do not have an email address or a cell phone

Treatment and study plan

Virtually administered Cardiac Rehab program

Other

Virtual cardiac rehab program delivered through the CardaHealth platform.

Standard of Care in person Cardiac Rehab Program

Other

Clinically ordered standard of care cardiac rehab program (in-person).

Primary outcomes

  1. Change in VO2 max (ml/kg/min)

    Time frame: At baseline visit and at the end of study approximately 40 weeks

    Cardiorespiratory fitness as assessed by maximal VO2

Secondary outcomes

  1. Attendance

    Time frame: Mean number of cardiac rehab sessions completed per patient, over the course of 12 weeks or 36 sessions.

    Subject's adherence to scheduled cardiac rehab sessions.

  2. Quality of Life questionnaire

    Time frame: Prior to beginning of cardiac rehabilitation and then at completion of cardiac rehabilitation program approximately 36 weeks

    Subject's completion of SF-36

  3. Blood Pressure

    Time frame: Start of each cardiac rehab session, over the course of 12 weeks or 36 sessions.

    Change in systolic and diastolic blood pressure over the duration of the study. BP will be self-assessed by the subjects at the start of each session.

  4. Major adverse cardiovascular events (MACE)

    Time frame: Events will be collected up to 27 months post study enrollment

    Major cardiovascular events include cardiovascular hospitalizations and mortality

  5. Survey

    Time frame: At completion of cardiac rehabilitation program approximately 36 weeks

    Patient satisfaction, physician satisfaction

  6. Change in LDL

    Time frame: Labs will be collected up to 27 months post study enrollment

    Ascertained through the electronic health through routinely collected values

  7. Change in HDL

    Time frame: Labs will be collected up to 27 months post study enrollment

    Ascertained through the electronic health through routinely collected values

  8. Change in triglycerides

    Time frame: Labs will be collected up to 27 months post study enrollment

    Ascertained through the electronic health through routinely collected values

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • CardaHealth
  • Independence Blue Cross

Registry information

Official study title

A Clinical Trial Investigating the Effects of a Virtually Implemented Home Based Cardiac Rehab Program with Real-time, Video-based Exercise Supervision and Vitals Monitoring

Acronym: VIRT-CR

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 21, 2022
Registry last updated
Nov 6, 2024

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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