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 — DEVICEParticipants 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 — DEVICEParticipants 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 rehabilitationCardiac rehabilitation delivered through Movn app through the use of mHealth.
- Active Comparator: Attention ControlThis 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Baylor Scott and White Health System | Dallas | Texas | 75246 | |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75209 |
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