Home-based Cardiac Rehabilitation in Heart Failure

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT06349941
Phase
PHASE3
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Movn app — DEVICE
    Participants will have 12-week home-based exercise program delivered via a commercially available home-based cardiac rehabilitation platform called Movn. The plan includes an accelerometer, blood pressure scale, and mobile application.
  • Accelerometer — DEVICE
    Participants will receive a FitBit for monitoring of physical function.

Study Details

This study evaluates a mobile health (mHealth) home-based cardiac rehabilitation program for patients with heart failure. We will stratify randomization between rural and urban populations, with the goal to assess implementation of cardiac rehabilitation across these two geographic areas. . The study will randomize 332 patients with heart failure (ejection fraction ≥35%) who are not eligible for center-based rehabilitation to either a 12-week mHealth cardiac rehabilitation program or an attention control group, with outcomes measured over 6 months using a composite endpoint of mortality, hospitalizations, and quality of life. We will then assess the implementation of the intervention.

Key Dates

Start date
Aug 15, 2025
Status verified
May 2026
Primary completion
Dec 1, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
332 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Movn cardiac rehabilitation
    Cardiac rehabilitation delivered through Movn app through the use of mHealth.
  • Active Comparator: Attention Control
    This group will receive a wearable device for step count tracking and will get periodic check ins to minimize differential attention between groups. They will not receive an exercise plan.

Primary Outcome Measure

Composite Hierarchical Endpoint [ Time Frame: 6 months. ]

Locations (2)

FacilityCityStateZIPSite coordinators
Baylor Scott and White Health SystemDallasTexas75246
Neil Keshvani, MD
214-645-7181
University of Texas Southwestern Medical CenterDallasTexas75209
Ambarish Pandey, MD
214-645-9868

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