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

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

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.

Sponsors & Collaborators

• Medical University of South Carolina

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• Duke Clinical Research Institute

  collaborator OTHER

• National Institute on Aging (NIA)

  collaborator NIH

• University of Michigan

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• Piedmont Healthcare

  collaborator OTHER

• Wake Forest University Health Sciences

  collaborator OTHER

• Morristown Medical Center

  collaborator OTHER

• Vanderbilt University Medical Center

  lead OTHER

Principal Investigators

• Brian R. Lindman, MD, MSc · Vanderbilt University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-15

Primary Completion

2026-06-01

Completion

2026-10-01

Countries

• United States

Study Locations