Home-based cardiac rehabilitation after heart valve procedures
Home-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions
NA · Vanderbilt University Medical Center · NCT06077201
This study tests a home-based cardiac rehab program using a mobile app to see if it helps people who have had heart valve procedures improve their health without going to a rehab center.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center (other) |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT06077201 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a home-based cardiac rehabilitation (HBCR) program delivered through a custom mobile app for patients who have undergone transcatheter heart valve interventions. Participants who are not planning to attend center-based cardiac rehabilitation will be randomized into three groups: a control group, a hands-off HBCR group, and an interactive HBCR group. The intervention aims to improve health behaviors and includes traditional cardiac rehabilitation components, with participants receiving either a 12-week or 24-week intervention. The study seeks to address the barriers that prevent individuals from participating in conventional rehabilitation programs.
Who should consider this trial
Good fit: Ideal candidates are patients who have undergone a transcatheter heart valve intervention via transfemoral access and are not planning to participate in center-based cardiac rehabilitation.
Not a fit: Patients who have had their transcatheter heart valve intervention through a route other than transfemoral or those requiring a walker may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance recovery and health outcomes for patients with valvular heart disease by providing accessible rehabilitation options.
How similar studies have performed: Other studies have shown promise in home-based rehabilitation approaches, indicating potential for success with this novel intervention.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (RECRUITING)
Study contacts
- Principal investigator: Brian R. Lindman, MD, MSc — Vanderbilt University Medical Center
- Study coordinator: Anna Vatterott, MPH
- Email: anna.vatterott@vumc.org
- Phone: 615-936-5798
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Valvular Heart Disease, cardiac rehabilitation, transcatheter heart valve intervention, cardiology, aortic stenosis, mitral regurgitation, tricuspid regurgitation