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Clinical Trials/NCT05201976
NCT05201976
Completed
N/A

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

University of Pennsylvania1 site in 1 country52 target enrollmentNovember 8, 2021
ConditionsHeart Failure

Overview

Phase
N/A
Intervention
Not specified
Conditions
Heart Failure
Sponsor
University of Pennsylvania
Enrollment
52
Locations
1
Primary Endpoint
Change in VO2 max (ml/kg/min)
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 8, 2021
End Date
October 15, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Neel Chokshi

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Quality of Life questionnaire(Prior to beginning of cardiac rehabilitation and then at completion of cardiac rehabilitation program approximately 36 weeks)
  • Attendance(Mean number of cardiac rehab sessions completed per patient, over the course of 12 weeks or 36 sessions.)
  • Blood Pressure(Start of each cardiac rehab session, over the course of 12 weeks or 36 sessions.)
  • Change in LDL(Labs will be collected up to 27 months post study enrollment)
  • Major adverse cardiovascular events (MACE)(Events will be collected up to 27 months post study enrollment)
  • Survey(At completion of cardiac rehabilitation program approximately 36 weeks)
  • Change in HDL(Labs will be collected up to 27 months post study enrollment)
  • Change in triglycerides(Labs will be collected up to 27 months post study enrollment)

Study Sites (1)

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