Home-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center

About this trial

The vast majority of cardiac rehabilitation eligible individuals do not participate in center based cardiac rehabilitation (CBCR). While steps to encourage participation in CBCR are important, many individuals will still not participate for a variety of reasons. This randomized controlled trial is evaluating a home-based cardiac rehabilitation (HBCR) intervention delivered using a custom app and digital tools in patients undergoing transcatheter heart valve interventions (THVIs). After a brief roll-in period, participants not intending to participate in CBCR are randomized to one of three groups: (1) control, (2) HBCR mobile health intervention with hands-off delivery, and (3) HBCR mobile health intervention with interactive delivery. Participants in the intervention groups (hands-off/interactive delivery) will also be randomized to continue the intervention for 12 weeks or 24 weeks. The intervention targets key health behaviors and includes traditional cardiac rehabilitation components. The study will assess the effect of the intervention on clinical events, physical activity, quality of life, and other outcomes. Those who intend to participate in CBCR will be followed in a registry.

Eligibility criteria

Qualifiers

Treated with a transcatheter heart valve intervention (e.g., transcatheter aortic valve implantation [in the native valve or valve-in-valve], mitral transcatheter edge-to-edge repair, mitral valve-in-valve) of the aortic, mitral, or tricuspid valve done via transfemoral access

Disqualifiers

Unwilling or unable to provide informed consent

Not adherent to wearing the ActiGraph activity tracker during the roll-in phase for a minimum of 4 (out of 7) compliant days (worn >10 hours/day)

Planned participation in center based cardiac rehabilitation (CBCR)

Transcatheter heart valve intervention done via any route other than a transfemoral approach

Trial design

Treatments tested in this trial

  • HBCR hands-off
  • HBCR interactive

Treatment groups

240 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Vanderbilt University Medical Center

Lead sponsor

Medical University of South Carolina

Collaborator

University of Pittsburgh

Collaborator

Duke Clinical Research Institute

Collaborator

National Institute on Aging (NIA)

Collaborator

University of Michigan

Collaborator

The Cleveland Clinic

Collaborator

University of Colorado, Denver

Collaborator

Piedmont Healthcare

Collaborator

Wake Forest University Health Sciences

Collaborator

Morristown Medical Center

Collaborator