NCT06077201 · Vanderbilt University Medical Center
Home-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions
(HOMERUNHITTER)
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
HBCR hands-off
Home-based cardiac rehabilitation intervention facilitated by a custom app to deliver education, counseling on healthy living and modification of risk factors, mindfulness, and physical activity guidance.
OTHER
HBCR interactive
Home-based cardiac rehabilitation intervention facilitated by a custom app to deliver education, counseling on healthy living and modification of risk factors, mindfulness, and physical activity guidance. Additionally, there are periodic video calls with an exercise physiologist.
Primary outcome measures
Probability of the hierarchical clinical event composite
Time frame: Over the entire available follow-up period for randomized participants (minimum of 6 months, maximum approximately 24-30 months).
The hierarchical clinical event composite includes (in order of hierarchy): (1) all-cause death; (2) all-cause hospitalization; and (3) skilled nursing facility visits. To examine whether the intervention improves mortality, hospitalization, and SNF rates after THVIs, we will conduct Bayesian Markov longitudinal proportional odds model on weekly outcome measures. The pooled active treatment vs. control group comparison (primary comparison for the trial) will be estimated by contrasting the average of posterior probability that Y≥y of the two active treatment groups (hands-off HBCR and interactive HBCR) to the control group.
Average daily total activity counts
Time frame: The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily total activity counts determined. The primary comparison will be at 12 weeks after randomization.
Daily total activity counts are determined by a triaxial actigraphy device.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Nashville, Tennessee
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
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 15, 2026 · Source of record for eligibility and locations