Comparing two exercise programs for older adults with heart failure
Compares a new exercise program with standard training in older adults with heart failure.
Plain-language title generated from the registry record
Registry title: PRIME HFrEF: Novel Exercise for Older Patients With Heart Failure With Reduced Ejection Fraction
Key facts
- Where
- Charlottesville, United StatesSee the site
Where in United States
- University of Virginia, Department of KinesiologyCharlottesville, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Virginia
- Trial code
- NCT05609097
- Record updated
- 6 June 2025
- Original description
This study is trying to find out whether performing a hybrid aerobic-resistance exercise training program (titled PRIME: Peripheral Remodeling via Intermittent Muscular Exercise) results in better health outcomes than the traditional exercise training program (called COMBO) that is used in individuals with heart failure with reduced ejection fraction (HFrEF). Participants will be randomized (like the flip of a coin) to either PRIME (investigational) or the traditional exercise program (standard of care).Read full original descriptionShow less
PRIME HFrEF: Novel Exercise for Older Patients With Heart Failure With Reduced Ejection Fraction
This study is trying to find out whether performing a hybrid aerobic-resistance exercise training program (titled PRIME: Peripheral Remodeling via Intermittent Muscular Exercise) results in better health outcomes than the traditional exercise training program (called COMBO) that is used in individuals with heart failure with reduced ejection fraction (HFrEF). Participants will be randomized (like the flip of a coin) to either PRIME (investigational) or the traditional exercise program (standard of care).
Inclusion: Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent; Subjects may be of either sex with age > 65 years; Subjects must be diagnosed with HFrEF as per established echocardiographic criteria (New York Heart Association Class II-III) with an ejection fraction <45%; Cardiologist approve after thorough chart review and physical examination; Hemoglobin of at least 10.0 g/dL.
Exclusion: Progressive worsening of exercise tolerance or dyspnea at rest or on exertion over previous 3-5 days; Myocardial infarction within previous 3 weeks; Acute systemic illness of fever; Regurgitant valvular heart disease requiring surgery; Resting Heart Rate >120bpm; Uncontrolled diabetes (HbA1c >10%); Significant ischemia at low exercise intensities (<2 METS or ~50 W); Recent embolism (in the 6 weeks); Deep Vein Thrombophlebitis; Active pericarditis or myocarditis; Severe aortic stenosis (aortic valve area <1.0 cm2); New onset atrial fibrillation (in the last 4 weeks).