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

Study acronym: HOMERUNHITTER
StatusRecruiting
PhaseNot applicable
Started2023-12-15
View on ClinicalTrials.gov ↗
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.

Amendment history 4 changes detected by DataLookout

2026-09-05
Primary completion pushed: 2026-06-01 → 2027-02-01
2026-09-05
Completion pushed: 2026-10-01 → 2027-04-01
2026-05-16
Primary completion moved earlier: 2027-03-01 → 2026-06-01
2026-05-16
Completion moved earlier: 2027-05-01 → 2026-10-01
Trial Details
NCT Number NCT06077201
Lead Sponsor Vanderbilt University Medical Center
Collaborators: Medical University of South Carolina, University of Pittsburgh, Duke Clinical Research Institute, National Institute on Aging (NIA), University of Michigan, The Cleveland Clinic, University of Colorado, Denver, Piedmont Healthcare, Wake Forest University Health Sciences, Morristown Medical Center
Conditions Valvular Heart Disease
Enrollment 240 participants
Start Date 2023-12-15
Primary Completion 2027-02-01 (estimated)
Study Completion 2027-04-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-04