Recruiting

Novel Exercise

Sponsor:

University of Virginia

Code:

NCT05609097

Conditions

Heart Failure With Reduced Ejection Fraction

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

PRIME

COMBO

Study Details

Brief 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).

Conditions

Heart Failure With Reduced Ejection Fraction

Study ID

NCT05609097

Start date

Apr 14, 2023

Status verified date

Jun, 2025

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

92 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PRIME + COMBO

PRIME training (Phase 1), followed by 8 weeks of progressive whole-body COMBO training.

other: COMBO only

4 weeks of standard progressive whole-body aerobic plus resistance training (COMBO) followed by 8 weeks continued COMBO training.

Interventions

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.

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.

Primary outcome measure

  • VO2peak [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Locations

University of Virginia, Department of Kinesiology

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Principal Investigator:

Jason Allen, PhD

More Information

Sponsor

University of Virginia

Last update posted

Jun 6, 2025

Last verified

Jun, 2025

Keywords

  • HFrEF
  • VO2peak

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2025-06-06.