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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).
This study is a two-arm, prospective randomized clinical trial with participants randomized, in a 1:1 ratio to 4 weeks of either standard progressive whole-body aerobic plus resistance training (COMBO) or PRIME training (Phase 1), followed by 8 weeks of progressive whole-body COMBO assigned to all participants (Phase 2). The objective of this study is to determine whether PRIME exercise training can outperform traditional (COMBO) exercise training to improve outcomes in HFrEF patients. The study aims to test 92 HFrEF patients (46 randomized to PRIME and 46 to COMBO training) over a 5-year period. Data will be collected at each visit and patients will return for a 6-month follow up from the date of the final visit.
Age
65 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Virginia, Department of Kinesiology
Charlottesville, Virginia, United States
Start Date
April 14, 2023
Primary Completion Date
December 31, 2027
Completion Date
June 30, 2028
Last Updated
June 6, 2025
92
ESTIMATED participants
PRIME
OTHER
COMBO
OTHER
Lead Sponsor
University of Virginia
Collaborators
NCT07057466
NCT06859970
Data Source & Attribution
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