PRIME HFrEF: Novel Exercise for Older Patients With Heart Failure With Reduced Ejection Fraction
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- University of Virginia
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- VO2peak
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
Brief 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).
Detailed Description
This study is a two-arm, prospective randomized clinical trial with participants randomized, in a 1:1 ratio to 4 weeks of either standard progressive whole-body aerobic plus resistance training (COMBO) or PRIME training (Phase 1), followed by 8 weeks of progressive whole-body COMBO assigned to all participants (Phase 2). The objective of this study is to determine whether PRIME exercise training can outperform traditional (COMBO) exercise training to improve outcomes in HFrEF patients. The study aims to test 92 HFrEF patients (46 randomized to PRIME and 46 to COMBO training) over a 5-year period. Data will be collected at each visit and patients will return for a 6-month follow up from the date of the final visit.
Investigators
Jason Allen
principle investigator
University of Virginia
Eligibility Criteria
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
Outcomes
Primary Outcomes
VO2peak
Time Frame: 12 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.
Secondary Outcomes
- Muscular fitness(40- weeks)
- Physical Function(40- weeks)