Back to resultsPRIME HFrEF: Novel Exercise for Older Patients With Heart Failure With Reduced Ejection Fraction
Primary Purpose
Heart Failure With Reduced Ejection Fraction
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PRIME
COMBO
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure With Reduced Ejection Fraction focused on measuring HFrEF, VO2peak
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 <40%. 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
Sites / Locations
- University of Virginia, Department of KinesiologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
PRIME + COMBO
COMBO only
Arm Description
PRIME training (Phase 1), followed by 8 weeks of progressive whole-body COMBO training.
4 weeks of standard progressive whole-body aerobic plus resistance training (COMBO) followed by 8 weeks continued COMBO training.
Outcomes
Primary Outcome Measures
VO2peak
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 Outcome Measures
Muscular fitness
Evaluated using 1 repetition maximal strength [1RM] measured in kg units
Physical Function
Evaluated by the Senior Fitness Test scores [SFT], measured in percentile units.
Full Information
NCT ID
NCT05609097
First Posted
November 1, 2022
Last Updated
May 8, 2023
Sponsor
University of Virginia
Collaborators
National Institutes of Health (NIH), National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT05609097
Brief Title
PRIME HFrEF: Novel Exercise for Older Patients With Heart Failure With Reduced Ejection Fraction
Official Title
PRIME HFrEF: Novel Exercise for Older Patients With Heart Failure With Reduced Ejection Fraction
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2023 (Actual)
Primary Completion Date
November 30, 2026 (Anticipated)
Study Completion Date
March 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
National Institutes of Health (NIH), National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Reduced Ejection Fraction
Keywords
HFrEF, VO2peak
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized open-label blinded endpoint (PROBE) parallel-group design. Participants will be randomized to PRIME or COMBO training for an initial four weeks (Phase 1). Following this, all participants will complete an additional eight weeks of COMBO training (Phase 2). Participants will be randomized in a 1:1 ratio by an independent statistician James Patrie (permuted block randomization with block size of 4, stratified by gender), with treatment allocation revealed after baseline exercise testing. Outcomes will be assessed at baseline, four weeks and eight weeks and 36 weeks (exploratory aim 5) by a blinded assessor (UVA SoM Exercise Core Laboratory).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PRIME + COMBO
Arm Type
Experimental
Arm Description
PRIME training (Phase 1), followed by 8 weeks of progressive whole-body COMBO training.
Arm Title
COMBO only
Arm Type
Other
Arm Description
4 weeks of standard progressive whole-body aerobic plus resistance training (COMBO) followed by 8 weeks continued COMBO training.
Intervention Type
Other
Intervention Name(s)
PRIME
Other Intervention Name(s)
Exercise
Intervention Description
PRIME is a a 'hybrid' aerobic-resistance (cardio and weights) program designed to target all major muscle groups and address the muscle limitations responsible for reduced fitness in the elderly. This occurs by minimizing the central limitations to more traditional exercise by delivering an ideal exercise stimulus to muscles in a way in which the heart is not a limiting factor. Each exercise involves contractions of specific isolated muscle groups with a moderate load, defined as 40%-50% of their maximal voluntary capacity.
Intervention Type
Other
Intervention Name(s)
COMBO
Other Intervention Name(s)
Exercise
Intervention Description
COMBO training includes both aerobic ("cardio") and resistance ("weightlifting") exercises. The aerobic component will be done on the stationary bicycle at 10-15 min duration at a target exercise intensity of 40-50% of VO2peak. This will feel like an intensity that is fairly light to somewhat hard, progressing gradually according to tolerance up to 20 mins. Intensity will be adjusted so that the difficulty remains in the target zone. The resistance component involves eight exercises, two sets of 10 repetitions, initially prescribed at 50-60% 1 repetition max. Subject will lift about half of their predicted maximal strength, 10 times, on 2 separate occasions with a rest between. Thereafter, the difficulty will be increased by approximately 10% when difficulty drops below the target range.
Primary Outcome Measure Information:
Title
VO2peak
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Muscular fitness
Description
Evaluated using 1 repetition maximal strength [1RM] measured in kg units
Time Frame
40- weeks
Title
Physical Function
Description
Evaluated by the Senior Fitness Test scores [SFT], measured in percentile units.
Time Frame
40- weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 <40%.
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Guy, B.S
Phone
434-243-8677
Email
ejg9rb@virginia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Allen, PhD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia, Department of Kinesiology
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Guy, B.S
Phone
434-243-8677
Email
ejg9rb@virginia.edu
First Name & Middle Initial & Last Name & Degree
Jason Allen, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
29232316
Citation
Allen JD, Vanbruggen MD, Johannsen NM, Robbins JL, Credeur DP, Pieper CF, Sloane R, Earnest CP, Church TS, Ravussin E, Kraus WE, Welsch MA. PRIME: A Novel Low-Mass, High-Repetition Approach to Improve Function in Older Adults. Med Sci Sports Exerc. 2018 May;50(5):1005-1014. doi: 10.1249/MSS.0000000000001518.
Results Reference
background
PubMed Identifier
22993497
Citation
Shoemaker MJ, Curtis AB, Vangsnes E, Dickinson MG. Triangulating Clinically Meaningful Change in the Six-minute Walk Test in Individuals with Chronic Heart Failure: A Systematic Review. Cardiopulm Phys Ther J. 2012 Sep;23(3):5-15.
Results Reference
background
PubMed Identifier
23900005
Citation
Allen JD, Robbins JL, Vanbruggen MD, Credeur DP, Johannsen NM, Earnest CP, Pieper CF, Johnson JL, Church TS, Ravussin E, Kraus WE, Welsch MA. Unlocking the barriers to improved functional capacity in the elderly: rationale and design for the "Fit for Life trial". Contemp Clin Trials. 2013 Sep;36(1):266-75. doi: 10.1016/j.cct.2013.07.007. Epub 2013 Jul 27.
Results Reference
background
PubMed Identifier
12849670
Citation
Rickli H, Kiowski W, Brehm M, Weilenmann D, Schalcher C, Bernheim A, Oechslin E, Brunner-La Rocca HP. Combining low-intensity and maximal exercise test results improves prognostic prediction in chronic heart failure. J Am Coll Cardiol. 2003 Jul 2;42(1):116-22. doi: 10.1016/s0735-1097(03)00502-3.
Results Reference
background
PubMed Identifier
28772048
Citation
Angadi SS, Jarrett CL, Sherif M, Gaesser GA, Mookadam F. The effect of exercise training on biventricular myocardial strain in heart failure with preserved ejection fraction. ESC Heart Fail. 2017 Aug;4(3):356-359. doi: 10.1002/ehf2.12149. Epub 2017 Mar 16.
Results Reference
background
PubMed Identifier
25190739
Citation
Angadi SS, Mookadam F, Lee CD, Tucker WJ, Haykowsky MJ, Gaesser GA. High-intensity interval training vs. moderate-intensity continuous exercise training in heart failure with preserved ejection fraction: a pilot study. J Appl Physiol (1985). 2015 Sep 15;119(6):753-8. doi: 10.1152/japplphysiol.00518.2014. Epub 2014 Sep 4.
Results Reference
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PRIME HFrEF: Novel Exercise for Older Patients With Heart Failure With Reduced Ejection Fraction
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