Effect of a Virtually Implemented Cardiac Rehabilitation Program

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Other: Virtually administered Cardiac Rehab program; Other: Standard of Care in person Cardiac Rehab Program

• Registration Number: NCT05201976
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-11-08
• Study First Submitted: 2021-12-05
• Study First Submitted QC: 2022-01-07
• Study First Posted: 2022-01-21
• Primary Completion: 2024-10-15
• Study Completion: 2024-10-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Virtually administered Cardiac Rehab program	Virtual cardiac rehab program delivered through the CardaHealth platform.
Control	Standard of Care in person Cardiac Rehab Program	Clinically ordered standard of care cardiac rehab program (in-person).

Primary Outcome Measures

Name	Time	Method
Change in VO2 max (ml/kg/min)	At baseline visit and at the end of study approximately 40 weeks	Cardiorespiratory fitness as assessed by maximal VO2

Secondary Outcome Measures

Name	Time	Method
Quality of Life questionnaire	Prior to beginning of cardiac rehabilitation and then at completion of cardiac rehabilitation program approximately 36 weeks	Subject's completion of SF-36
Attendance	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.
Blood Pressure	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.
Change in LDL	Labs will be collected up to 27 months post study enrollment	Ascertained through the electronic health through routinely collected values
Major adverse cardiovascular events (MACE)	Events will be collected up to 27 months post study enrollment	Major cardiovascular events include cardiovascular hospitalizations and mortality
Survey	At completion of cardiac rehabilitation program approximately 36 weeks	Patient satisfaction, physician satisfaction
Change in HDL	Labs will be collected up to 27 months post study enrollment	Ascertained through the electronic health through routinely collected values
Change in triglycerides	Labs will be collected up to 27 months post study enrollment	Ascertained through the electronic health through routinely collected values

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States