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

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Oct 4, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help patients recover from heart valve procedures by using a mobile app for home-based cardiac rehabilitation (HBCR). Many people who could benefit from traditional in-person cardiac rehab programs don’t participate for various reasons, so this trial aims to see if using digital tools at home can help improve their recovery. Participants will be divided into three groups: one that receives no extra intervention, one that gets the app without much interaction, and another that has more interactive support. They will also be assigned to either a 12-week or 24-week program to see how long the support helps.

To be eligible for this study, participants must have undergone a specific type of heart valve procedure through a leg artery. Key requirements include being able to give consent and using a fitness tracker during the initial phase. Patients who plan to attend traditional rehab programs or have certain health issues that affect their mobility might not qualify. Throughout the trial, participants will track their health and well-being, and the study will look at how this home-based support affects their physical activity, quality of life, and overall health outcomes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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
• • Stroke during or immediately after the transcatheter heart valve intervention prior to randomization
• • Placement of a pacemaker within 6 weeks prior to the transcatheter heart valve intervention or after the transcatheter heart valve intervention and prior to randomization
• • Those who require a walker or who cannot get out of a chair/bed on their own and walk independently (use of a cane is acceptable)
• • Physical or neuropsychiatric limitations that would prevent proficient use of the study tools and successful completion of the physical and quality of life assessments (e.g. blindness, dementia)
• • Planned surgery within 6 months after the heart valve intervention
• • Planned discharge from hospital to hospice, assisted living, or inpatient rehabilitation facility (discharge to a senior facility permitted as long as they are considered Independent Living)
• • Treating provider or site PI indicates that participation in the study would be unsafe
• • Participation in any ongoing randomized trial that has not completed follow-up unless the sponsor of the other trial allows enrollment of the participant in this cardiac rehabilitation trial
• • Unable to complete the baseline study visit prior to 6 weeks after the transcatheter heart valve intervention