Exercise Program for Heart Failure
Trial Summary
What is the purpose of 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).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment COMBO, Traditional Exercise Training Program, Standard of Care Exercise Program, PRIME, Peripheral Remodeling via Intermittent Muscular Exercise for heart failure?
Research shows that exercise training is safe and improves health status and exercise capacity in heart failure patients, helping to reduce abnormal changes in the body caused by the condition. Additionally, peripheral muscle training can lead to significant muscle adaptation with minimal stress on the heart, which may benefit heart failure patients who cannot engage in traditional exercise.12345
Is exercise training safe for people with heart failure?
How does the exercise program for heart failure differ from other treatments?
This exercise program for heart failure is unique because it combines moderate-intensity aerobic and resistance training, and includes a preliminary phase called Peripheral Remodeling through Intermittent Muscular Exercise (PRIME) to enhance aerobic capacity and muscle strength more effectively than traditional exercise programs.710111213
Research Team
Jason Allen, PhD
Principal Investigator
University of Virginia
Eligibility Criteria
This trial is for individuals over 65 with heart failure and reduced ejection fraction (HFrEF), specifically those who can communicate well, have cardiologist approval, and a hemoglobin level of at least 10.0 g/dL. It's not for people with uncontrolled diabetes, recent heart attacks or embolism, severe valve disease needing surgery, new atrial fibrillation, worsening symptoms in the past few days, significant ischemia during low exercise levels, or certain other acute conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase 1: Treatment
Participants undergo 4 weeks of either PRIME or COMBO exercise training
Phase 2: Treatment
All participants undergo 8 weeks of progressive whole-body COMBO training
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- COMBO
- PRIME
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Virginia
Lead Sponsor
National Institute on Aging (NIA)
Collaborator
National Institutes of Health (NIH)
Collaborator