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PRIME HFrEF: Exercise for Older Patients with Heart Failure

This study is looking at whether a new exercise program called PRIME works better than a traditional exercise program (COMBO) for older adults with heart failure with reduced ejection fraction (HFrEF). HFrEF means your heart can't pump enough blood to your body. PRIME is a 'hybrid' program combining cardio and weights, designed to improve fitness. COMBO also includes cardio and weights. You might be able to join if you are over 65, have HFrEF (NYHA Class II-III, with an ejection fraction less than 45%), and can communicate with the study team. The main goal is to see if PRIME improves your VO2peak (a measure of fitness) after 12 weeks. The study is currently recruiting participants.

Study design
This is a randomized study where 92 participants will be assigned by chance to either the PRIME or COMBO exercise program. The study has two phases, with all participants doing COMBO in the second phase.
What's involved
Participants will engage in either the PRIME or COMBO exercise program for 4 weeks, followed by 8 weeks of COMBO training. Data will be collected at each visit.
Compensation
Not stated in the trial record.
Follow-up
Participants will have a 6-month follow-up from the date of their final visit.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05609097

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

Recruiting
NAAges 65+InterventionalTreatment
University of Virginia
~92 participants
Updated 2025-06-06 on ClinicalTrials.gov
What's tested:PRIMECOMBO

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
VO2peak
Measured over 12 weeks

Conditions

Heart Failure With Reduced Ejection Fraction

Explore related trials

Heart failure with reduced ejection fraction

NCT05609097

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Virginia, Department of Kinesiology

    Charlottesville, Virginiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jason Allen, PhD · PRINCIPAL_INVESTIGATOR · University of Virginia

Who to contact

Ben Stephenson
[email protected]
434-243-8677
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • VO2peak12 weeks

    Change in cardiorespiratory fitness (peak oxygen consumption \[V̇O2peak\]) after 12 weeks of training. The primary null hypothesis will test if mean change in V̇O2peak after 12 weeks of training is the same for subjects who initially undergo 4 weeks of PRIME before undergoing 8 weeks of progressive whole-body COMBO, versus subjects who undergo the whole 12 weeks of progressive COMBO. The alternative hypothesis is that the mean change in V̇O2peak after 12 weeks of training is not the same for subjects who initially undergo 4 weeks of PRIME training before undergoing 8 weeks of progressive COMBO, versus subjects who undergo the whole 12 weeks of progressive COMBO. Secondary endpoints include blood pressure, vascular function \[arterial stiffness, endothelial function (FMD)\] muscle characteristics and histochemistry, blood chemistry, physical fitness testing, quality of life questionnaires, and adherence.