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

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.

Study Overview

• Status: Recruiting
• Conditions: Valvular Heart Disease
• Intervention / Treatment: Other: HBCR hands-off; Other: HBCR interactive

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Vatterott, MPH; Phone Number: 615-936-5798; Email: anna.vatterott@vumc.org
• Study Contact Backup: Name: Caleb Hayes, MPH; Email: caleb.hayes@vumc.org

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Vanderbilt University Medical Center
      • Contact: Anna Vatterott, MPH; Phone Number: 615-936-5798; Email: anna.vatterott@vumc.org
      • Contact: Caleb Hayes, MPH; Email: caleb.hayes@vumc.org
      • Principal Investigator: Brian R. Lindman, MD, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard of care course for an individual not participating in center based cardiac rehabilitation. AHA Life's Essential 8 Fact Sheets are provided to promote healthy living.
Experimental: HBCR hands-off; Home-based cardiac rehabilitation with mobile application + AHA Life's Essential 8 sheets.	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.
Experimental: HBCR interactive; Home-based cardiac rehabilitation with mobile application and periodic video calls with exercise physiologist + AHA Life's Essential 8 sheets.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average daily total activity counts	Daily total activity counts are determined by a triaxial actigraphy device.	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.
Probability of the hierarchical clinical event composite	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.	Over the entire available follow-up period for randomized participants (minimum of 6 months, maximum approximately 24-30 months).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average daily total activity counts	Daily total activity counts are determined by a triaxial actigraphy device.	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.
Average daily active minutes	Daily active minutes are determined by a triaxial actigraphy device.	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.
Average daily steps	Daily steps are determined by a triaxial actigraphy device.	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.
Average daily energy expenditure	Daily energy expenditure is determined by a triaxial actigraphy device.	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.
Average daily moderate to vigorous active minutes	Daily moderate to vigorous active minutes are determined by a triaxial actigraphy device.	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.
6 minute walk distance	The distance walked in 6 minutes.	The comparisons will be at 12, 24 and 52 weeks after randomization.
Chair sit to stand time	The time taken to complete 5 chair rises.	The comparisons will be at 12, 24 and 52 weeks after randomization.
5 meter gait speed	The speed of walking 5 meters (meters/second).	The comparisons will be at 12, 24 and 52 weeks after randomization.
All-cause hospitalizations	Hospitalizations for any reason	Over the entire available follow-up period for randomized participants (minimum of 6 months, maximum approximately 24-30 months).
All-cause death	Death for any cause	Over the entire available follow-up period for randomized participants (minimum of 6 months, maximum approximately 24-30 months).
Patient goals progress score	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.	The comparisons will be at 12, 24 and 52 weeks after randomization.
Heart-failure specific health status assessed by the KCCQ	Assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ); (score range 0-100, higher is better health status)	The comparisons will be at 12, 24 and 52 weeks after randomization.
Physical health status assessed by the PROMIS 10	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)	The comparisons will be at 12, 24 and 52 weeks after randomization.
Mental health status assessed by the PROMIS 10	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)	The comparisons will be at 12, 24 and 52 weeks after randomization.
Mood disturbance assessed by PHQ9	Patient health questionnaire 9 (PHQ9); (score range 1-27, higher score worse)	The comparisons will be at 12, 24 and 52 weeks after randomization.
Basic mobility by AM-PAC	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)	The comparisons will be at 12, 24 and 52 weeks after randomization.

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: Medical University of South Carolina; University of Colorado, Denver; University of Pittsburgh; University of Michigan; The Cleveland Clinic; National Institute on Aging (NIA); Wake Forest University Health Sciences; Duke Clinical Research Institute; Piedmont Healthcare; Morristown Medical Center
• Investigators: Principal Investigator: Brian R. Lindman, MD, MSc, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: October 4, 2023
• First Submitted That Met QC Criteria: October 4, 2023
• First Posted (Actual): October 11, 2023

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: mitral regurgitation; aortic stenosis; cardiology; tricuspid regurgitation; cardiac rehabilitation; transcatheter heart valve intervention
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Tricuspid Valve Insufficiency; Mitral Valve Insufficiency; Heart Valve Diseases
• Other Study ID Numbers: 222231; 5R01AG073633-02 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No