Home-based cardiac rehabilitation for people with heart failure
Implementing a Home-based Cardiac Rehabilitation Program Among Rural Patients With Heart Failure
PHASE3 · University of Texas Southwestern Medical Center · NCT06349941
This 12-week mobile app cardiac rehab program tests whether home-based rehab can improve outcomes for people with heart failure (EF ≥35%) who cannot attend center-based programs.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 332 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center (other) |
| Locations | 2 sites (Dallas, Texas and 1 other locations) |
| Trial ID | NCT06349941 on ClinicalTrials.gov |
What this trial studies
This Phase 3 randomized trial will enroll 332 patients with heart failure and left ventricular ejection fraction ≥35% who are not eligible for center-based rehabilitation and randomize them to a 12-week mHealth cardiac rehabilitation program using the Movn app plus accelerometer monitoring or to an attention control group. Randomization will be stratified by rural versus urban residence to compare implementation and effectiveness across geographic settings. The primary follow-up is six months and uses a composite endpoint of mortality, hospitalizations, and quality of life. The study will also measure implementation outcomes such as uptake, adherence, and feasibility in rural and urban participants.
Who should consider this trial
Good fit: Adults aged 18 or older with a recent hospitalization for acute heart failure, left ventricular ejection fraction ≥35%, who are unable to access center-based cardiac rehabilitation and have a smartphone and internet access are ideal candidates.
Not a fit: Patients with reduced ejection fraction below 35%, medical contraindications to exercise, life expectancy under six months, inability to use required technology, or those already enrolled in center-based cardiac rehab are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could expand access to cardiac rehabilitation, improve quality of life, and reduce hospitalizations for patients who cannot attend center-based rehab.
How similar studies have performed: Smaller home- and telehealth-based cardiac rehabilitation programs have shown improvements in exercise capacity and participation, but large randomized trials specifically in this heart failure population with rural versus urban stratification remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 years or older * History of hospitalization for acute heart failure with ejection fraction ≥ 35% * Ability to participate in telemedicine visits * Access to smartphone or device capable of running the mHealth application * Willingness to participate in home-based cardiac rehabilitation program Exclusion Criteria: * Heart failure with reduced ejection fraction (ejection fraction \< 35%) * Inability to participate in physical exercise or cardiac rehabilitation due to medical contraindications * Inability to provide informed consent * Lack of access to required technology (smartphone, internet connectivity) * Life expectancy less than 6 months * Inability to participate in telemedicine visits or remote monitoring * Current participation in another cardiac rehabilitation program
Where this trial is running
Dallas, Texas and 1 other locations
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (RECRUITING)
- Baylor Scott and White Health System — Dallas, Texas, United States (NOT_YET_RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure, telehealth, heart failure, rural, cardiac rehabilitaion