RECRUITINGINTERVENTIONAL

PRIME HFrEF: Novel Exercise for Older Patients With Heart Failure With Reduced Ejection Fraction

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written willing to sign a consent form. - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

OTHER

PRIME

PRIME is a a 'hybrid' aerobic-resistance (cardio and weights) program designed to target all major muscle groups and address the muscle limitations responsible for reduced fitness in the elderly. This occurs by minimizing the central limitations to more traditional exercise by delivering an ideal exercise stimulus to muscles in a way in which the heart is not a limiting factor. Each exercise involves contractions of specific isolated muscle groups with a moderate load, defined as 40%-50% of their maximal voluntary capacity.

OTHER

COMBO

COMBO training includes both aerobic ("cardio") and resistance ("weightlifting") exercises. The aerobic component will be done on the stationary bicycle at 10-15 min duration at a target exercise intensity of 40-50% of VO2peak. This will feel like an intensity that is fairly light to somewhat hard, progressing gradually according to tolerance up to 20 mins. Intensity will be adjusted so that the difficulty remains in the target zone. The resistance component involves eight exercises, two sets of 10 repetitions, initially prescribed at 50-60% 1 repetition max. Subject will lift about half of their predicted maximal strength, 10 times, on 2 separate occasions with a rest between. Thereafter, the difficulty will be increased by approximately 10% when difficulty drops below the target range.

Locations (1)

University of Virginia, Department of Kinesiology

Charlottesville, Virginia, United States