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

Description

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

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Study Overview

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Study Details

Study overview

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).

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

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

Condition
Heart Failure With Reduced Ejection Fraction
Intervention / Treatment

-

Contacts and Locations

Charlottesville

University of Virginia, Department of Kinesiology, Charlottesville, Virginia, United States, 22908

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 \<40%.
  • * Cardiologist approve after thorough chart review and physical examination
  • * Hemoglobin of at least 10.0 g/dL
  • * 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

Ages Eligible for Study

65 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Virginia,

Jason Allen, PhD, PRINCIPAL_INVESTIGATOR, University of Virginia

Study Record Dates

2028-03-31