Clinical trial NCT05201976: Effect of a Virtually Implemented Cardiac Rehabilitation Program
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Independence Blue Cross
name: CardaHealth
First posted: 2022-01-21
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, non-inferiority, Case vs. Control (1 to 1)
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Change in VO2 max (ml/kg/min)
timeFrame: At baseline visit and at the end of study approximately 40 weeks
Secondary outcomes:
measure: Attendance
timeFrame: Mean number of cardiac rehab sessions completed per patient, over the course of 12 weeks or 36 sessions.
measure: Quality of Life questionnaire
timeFrame: Prior to beginning of cardiac rehabilitation and then at completion of cardiac rehabilitation program approximately 36 weeks
measure: Blood Pressure
timeFrame: Start of each cardiac rehab session, over the course of 12 weeks or 36 sessions.
measure: Major adverse cardiovascular events (MACE)
timeFrame: Events will be collected up to 27 months post study enrollment
measure: Survey
timeFrame: At completion of cardiac rehabilitation program approximately 36 weeks
measure: Change in LDL
timeFrame: Labs will be collected up to 27 months post study enrollment
measure: Change in HDL
timeFrame: Labs will be collected up to 27 months post study enrollment
measure: Change in triglycerides
timeFrame: Labs will be collected up to 27 months post study enrollment
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Srinath Adusumalli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Neel Chokshi, MD
role: PRINCIPAL_INVESTIGATOR
References: