Promoting exercise in adults with heart failure with preserved ejection fraction
HEART (Heart Failure Exercise and Resistance Training) Camp Connect: Promoting Adherence to Exercise in Adults With Heart Failure With Preserved Ejection Fraction
This study is testing whether different types of exercise coaching can help adults with heart failure feel better and improve their physical health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Nebraska Academic / other |
| Locations | 3 sites (Detroit, Michigan and 2 other locations) |
| Trial ID | NCT05784753 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the effects of exercise coaching on adults with heart failure with preserved ejection fraction (HFpEF). Participants will be randomly assigned to one of three groups: one receiving in-person coaching, another using video conferencing for coaching, and a control group with access to exercise videos. Over 18 months, the study will assess exercise adherence, health status improvements, and changes in physical function and inflammatory markers. The study will also evaluate the cost-effectiveness and scalability of the intervention methods.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with HFpEF who are stable on their medications and able to participate in exercise.
Not a fit: Patients with life-limiting illnesses, unstable heart conditions, or those unable to safely engage in exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance exercise adherence and improve health outcomes for patients with HFpEF.
How similar studies have performed: Other studies have shown positive outcomes with exercise interventions in heart failure populations, suggesting this approach has potential.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of heart failure with an ejection fraction greater than or equal to 50 * Echocardiogram in prior 24 months * Stable pharmacologic therapy in the past 30 days * Any of the following evidence to confirm HFpEF - Score\< 6 on Heavy Hypertensive Atrial Fibrillation, Pulmonary Hypertension, Elder, Filling Pressure algorithm, invasive hemodynamic evidence of HFpEF(i.e., elevated pulmonary wedge pressure), or a confirmed clinical diagnosis of HFpEF Exclusion Criteria: * Life-limiting illness precluding study completion * Clinical evidence of decompensated heart failure * Unstable angina or marked shortness of breath on exertion at less than 2 metabolic equivalents * Myocardial infarction, coronary artery bypass graft, or biventricular pacemaker in prior 6 weeks * Orthopedic or neuromuscular disorders preventing aerobic exercise * Cardiopulmonary exercise test results that preclude safe exercise * Unwilling/unable to complete pre-randomization procedures * Pregnancy * Implantable cardioverter defibrillator
Where this trial is running
Detroit, Michigan and 2 other locations
- Henry Ford Health System — Detroit, Michigan, United States (Recruiting)
- University of Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
- University of Virginia — Charlottesville, Virginia, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Windy W Alonso, PhD — University of Virginia
- Study coordinator: Windy W Alonso, PhD
- Email: windy.alonso@unmc.edu
- Phone: 402-559-8342
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.