RecruitingNot ApplicableNCT05609097

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


Sponsor

University of Virginia

Enrollment

92 participants

Start Date

Apr 14, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests a novel exercise program designed specifically for older adults with heart failure with reduced ejection fraction (HFrEF) — a condition where the heart's pumping ability is significantly weakened — to see if it improves their exercise capacity and quality of life. **You may be eligible if...** - You are over 65 years old - You have been diagnosed with HFrEF (heart failure with reduced ejection fraction, ejection fraction below 45%, NYHA Class II–III) - Your cardiologist approves your participation after a thorough review - Your hemoglobin is at least 10 g/dL (not severely anemic) **You may NOT be eligible if...** - Your exercise tolerance has been getting progressively worse recently - You have breathlessness at rest or with minimal exertion - You have other serious heart conditions or unstable health that makes exercise unsafe (check with your cardiologist) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPRIME

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.

OTHERCOMBO

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

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NCT05609097


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