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NCT Number: NCT06077201

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

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.

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Key information

Conditions

Valvular Heart Disease Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency Tricuspid Valve Insufficiency Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location status: Recruiting

Location contact

Anna Vatterott, MPH

CONTACT

[email protected]

615-936-5798

Brian R. Lindman, MD, MSc

PRINCIPAL_INVESTIGATOR

Caleb Hayes, MPH

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HBCR hands-off

Other

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.

HBCR interactive

Other

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 outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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 secondary comparisons will be at 24 and 52 weeks after randomization.

    Daily total activity counts are determined by a triaxial actigraphy device.

  2. Average daily active minutes

    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 active minutes determined. The comparisons will be at 12, 24 and 52 weeks after randomization.

    Daily active minutes are determined by a triaxial actigraphy device.

  3. Average daily steps

    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 steps determined. The comparisons will be at 12, 24 and 52 weeks after randomization.

    Daily steps are determined by a triaxial actigraphy device.

  4. Average daily energy expenditure

    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 energy expenditure determined. The comparisons will be at 12, 24 and 52 weeks after randomization.

    Daily energy expenditure is determined by a triaxial actigraphy device.

  5. Average daily moderate to vigorous active minutes

    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 moderate to vigorous active mins determined. The comparisons will be at 12, 24 and 52 weeks after randomization.

    Daily moderate to vigorous active minutes are determined by a triaxial actigraphy device.

  6. 6 minute walk distance

    Time frame: The comparisons will be at 12, 24 and 52 weeks after randomization.

    The distance walked in 6 minutes.

  7. Chair sit to stand time

    Time frame: The comparisons will be at 12, 24 and 52 weeks after randomization.

    The time taken to complete 5 chair rises.

  8. 5 meter gait speed

    Time frame: The comparisons will be at 12, 24 and 52 weeks after randomization.

    The speed of walking 5 meters (meters/second).

  9. All-cause hospitalizations

    Time frame: Over the entire available follow-up period for randomized participants (minimum of 6 months, maximum approximately 24-30 months).

    Hospitalizations for any reason

  10. All-cause death

    Time frame: Over the entire available follow-up period for randomized participants (minimum of 6 months, maximum approximately 24-30 months).

    Death for any cause

  11. Heart-failure specific health status assessed by the KCCQ

    Time frame: The comparisons will be at 12, 24 and 52 weeks after randomization.

    Assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ); (score range 0-100, higher is better health status)

  12. Physical health status assessed by the PROMIS 10

    Time frame: The comparisons will be at 12, 24 and 52 weeks after randomization.

    Global physical health score from the PROMIS 10 Global Health Short Form questionnaire (raw score range 4-20 with corresponding T score and SE, higher is better)

  13. Mental health status assessed by the PROMIS 10

    Time frame: The comparisons will be at 12, 24 and 52 weeks after randomization.

    Global mental health score from the PROMIS 10 Global Health Short Form questionnaire (raw score range 4-20 with corresponding T score and SE, higher is better)

  14. Mood disturbance assessed by PHQ9

    Time frame: The comparisons will be at 12, 24 and 52 weeks after randomization.

    Patient health questionnaire 9 (PHQ9); (score range 1-27, higher score worse)

  15. Patient goals progress score

    Time frame: The comparisons will be at 12, 24 and 52 weeks after randomization.

    A patient goals progress score (-3 to +3) will be determined for 5 domains and the scores combined for a global score from -15 to +15.

  16. Basic mobility by AM-PAC

    Time frame: The comparisons will be at 12, 24 and 52 weeks after randomization.

    Basic mobility will be assessed with the Activity Measure for Post-Acute Care (AM-PAC) Basic Mobility Outpatient Short Form (Low Function); (raw score range 0-39 with corresponding T-score and SE, higher score is better)

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Vatterott, MPH

CONTACT

[email protected]

615-936-5798

Caleb Hayes, MPH

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • Duke Clinical Research Institute
  • Medical University of South Carolina
  • Morristown Medical Center
  • National Institute on Aging (NIA)
  • Piedmont Healthcare
  • The Cleveland Clinic
  • University of Colorado, Denver
  • University of Michigan
  • University of Pittsburgh
  • Wake Forest University Health Sciences

Registry information

Acronym: HOMERUNHITTER

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 11, 2023
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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