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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
United States
Virginia
University of Virginia, Department of Kinesiology
RECRUITING
Charlottesville
Contact Information
Primary
Ben Stephenson
bls4qq@virginia.edu
434-243-8677
Time Frame
Start Date: 2023-04-14
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 92
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Virginia
Collaborators: National Institute on Aging (NIA), National Institutes of Health (NIH)

This content was sourced from clinicaltrials.gov