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

NCT06077201 | Recruiting DMC

• 2 other identifiers: 2222315R01AG073633-02
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Valvular Heart Disease

Keywords

cardiac rehabilitation; transcatheter heart valve intervention; cardiology; aortic stenosis; mitral regurgitation; tricuspid regurgitation

Outcome Measures

Primary Outcomes (2)

• 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).

• 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.

Secondary Outcomes (16)

• Average daily total activity counts

  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

  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

  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

  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

  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.

Study Arms (3)

Control

NO INTERVENTION

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.

HBCR hands-off

EXPERIMENTAL

Home-based cardiac rehabilitation with mobile application + AHA Life's Essential 8 sheets.

Other: HBCR hands-off

HBCR interactive

EXPERIMENTAL

Home-based cardiac rehabilitation with mobile application and periodic video calls with exercise physiologist + AHA Life's Essential 8 sheets.

Other: HBCR interactive

Interventions

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 hands-off

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.

HBCR interactive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

RECRUITING

MeSH Terms

Conditions

Heart Valve Diseases; Aortic Valve Stenosis; Mitral Valve Insufficiency; Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Ventricular Outflow Obstruction

Study Officials

• Brian R. Lindman, MD, MSc

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Vatterott, MPH

CONTACT

615-936-5798; anna.vatterott@vumc.org

Caleb Hayes, MPH

CONTACT

caleb.hayes@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study coordinator performing the remote study visits will be blinded to the treatment group allocation until the participant has completed the study visit assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Associate Professor of Medicine

Model Details: Participants are randomized 1:1:1 to 3 groups.

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 11, 2023
• Study Start: December 15, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Locations

US (1)