Effect of a Virtually Implemented Cardiac Rehabilitation Program (VIRT-CR)

January 29, 2024 updated by: Neel Chokshi, University of Pennsylvania

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

225

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 Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19054
        • University of Pennsylvania

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention
Virtual cardiac rehab program delivered through the CardaHealth platform.
Other: Virtually administered Cardiac Rehab program
Virtual cardiac rehab program delivered through the CardaHealth platform.
Active Comparator: Control
Clinically ordered standard of care cardiac rehab program (in-person).
Other: Standard of Care in person Cardiac Rehab Program
Clinically ordered standard of care cardiac rehab program (in-person).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At baseline visit and at the end of study approximately 40 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Mean number of cardiac rehab sessions completed per patient, over the course of 12 weeks or 36 sessions.
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
Prior to beginning of cardiac rehabilitation and then at completion of cardiac rehabilitation program approximately 36 weeks
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.
Start of each cardiac rehab session, over the course of 12 weeks or 36 sessions.
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
Events will be collected up to 27 months post study enrollment
Survey
Time Frame: At completion of cardiac rehabilitation program approximately 36 weeks
Patient satisfaction, physician satisfaction
At completion of cardiac rehabilitation program approximately 36 weeks
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
Labs will be collected up to 27 months post study enrollment
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
Labs will be collected up to 27 months post study enrollment
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
Labs will be collected up to 27 months post study enrollment

Collaborators and Investigators

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

Sponsor

University of Pennsylvania

Collaborators

Independence Blue Cross
CardaHealth

Investigators

  • Principal Investigator: Srinath Adusumalli, MD, University of Pennsylvania
  • Principal Investigator: Neel Chokshi, MD, University of Pennsylvania

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)

December 8, 2021

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

December 5, 2021

First Submitted That Met QC Criteria

January 7, 2022

First Posted (Actual)

January 21, 2022

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 848902

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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