New exercise program for older patients with heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of a novel hybrid aerobic-resistance exercise program called PRIME compared to a traditional exercise program known as COMBO in older patients with heart failure with reduced ejection fraction (HFrEF). Participants aged over 65 will be randomly assigned to either the PRIME or COMBO training for four weeks, followed by eight weeks of COMBO for all participants. The goal is to determine if the PRIME program leads to better health outcomes than the standard approach. A total of 92 patients will be enrolled over a five-year period, with follow-up assessments conducted six months after the final visit.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Virginia, Department of Kinesiology
  Charlottesville, Virginia, United States Recruiting

Study contacts

• Principal investigator: Jason Allen, PhD — University of Virginia
• Study coordinator: Ben Stephenson
• Email: bls4qq@virginia.edu
• Phone: 434-243-8677

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• HFrEF polypill strategy in Sri Lanka

  This study tests whether giving a heart failure polypill can reduce death from heart disease and hospitalizations in adults with HFrEF in Sri Lanka, compared with usual care.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.