New exercise program for older patients with heart failure
PRIME HFrEF: Novel Exercise for Older Patients With Heart Failure With Reduced Ejection Fraction
This study is testing a new exercise program for older patients with heart failure to see if it helps them feel better compared to a standard exercise program.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University of Virginia Academic / other |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT05609097 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a novel hybrid aerobic-resistance exercise program called PRIME compared to a traditional exercise program known as COMBO in older patients with heart failure with reduced ejection fraction (HFrEF). Participants aged over 65 will be randomly assigned to either the PRIME or COMBO training for four weeks, followed by eight weeks of COMBO for all participants. The goal is to determine if the PRIME program leads to better health outcomes than the standard approach. A total of 92 patients will be enrolled over a five-year period, with follow-up assessments conducted six months after the final visit.
Who should consider this trial
Good fit: Ideal candidates are individuals over 65 years old diagnosed with HFrEF and able to provide informed consent.
Not a fit: Patients with severe comorbidities or recent acute illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved exercise-based rehabilitation strategies for older patients with heart failure, enhancing their overall health and quality of life.
How similar studies have performed: Other studies have shown positive outcomes with exercise interventions in heart failure patients, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Progressive worsening of exercise tolerance or dyspnea at rest or on exertion over previous 3-5 days * Significant ischemia at low exercise intensities (\<2 METS or \~50 W) * Uncontrolled diabetes (HbA1c \>10%) * Acute systemic illness of fever * Recent embolism (in the 6 weeks) * Deep Vein Thrombophlebitis * Active pericarditis or myocarditis * Severe aortic stenosis (aortic valve area \<1.0 cm2) * Regurgitant valvular heart disease requiring surgery * Myocardial infarction within previous 3 weeks * New onset atrial fibrillation (in the last 4 weeks) * Resting Heart Rate \>120bpm
Where this trial is running
Charlottesville, Virginia
- University of Virginia, Department of Kinesiology — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Jason Allen, PhD — University of Virginia
- Study coordinator: Ben Stephenson
- Email: bls4qq@virginia.edu
- Phone: 434-243-8677
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.