Tailored Exercise Training Study Among Adults With HFpEF
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Texas Southwestern Medical Center
About this trial
Heart failure with preserved ejection fraction (HFpEF) is associated with a high morbidity and mortality burden. There are limited pharmacological options available for the treatment of HFpEF. Exercise intolerance (EI) is the cardinal symptom of HFpEF, which manifests as dyspnea and fatigue. EI leads to functional deconditioning and reduced quality of life (QOL), both of which elevate risk of death and hospitalization in patients with HFpEF. Supervised exercised training is associated with improvements in exercise capacity and QOL in adults with HFpEF. However, supervised exercise has not been widely utilized for the treatment of HFpEF due to logistical and fiscal barriers.
This study will investigate the effects of a remote exercise training intervention on exercise capacity and skeletal muscle composition in patients with HFpEF, or those at risk for it. In addition, it will compare four different lifestyle interventions for their effects on exercise capacity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age>= 18 yrs
LVEF (Left Ventricular Ejection Fraction) >= 50%
History of HFpEF or at risk of HFpEF
HFpEF diagnosis based on:- -HF hospitalization within 12 months-
Disqualifiers
Hospitalization 1 month prior to baseline visit
History of recurrent falls
eGFR (Estimated Glomerular Filtration Rate) <20ml/min/1.73m
Active changes in HF therapies over 2 weeks prior to baseline visit
Trial design
Design model
Parallel
Treatments tested in this trial
Moderate-intensity continuous training (MCT)
BehavioralTailored moderate-intensity exercise training video with weekly virtual meetings with a coach
Resistance training
BehavioralResistance training videos assigned to patient
Weight loss
DrugInitiation/intensification of weight loss medications, such as semaglutide or tirzepatide
Treatment groups
120 Participants
are divided into 4 treatment groupsGroup A: Moderate-intensity continuous training (MCT)Active comparator 1 intervention
Group B: Moderate-intensity continuous training + weight lossExperimental treatment 2 interventions
Group C: Moderate-intensity continuous training + resistance trainingExperimental treatment 2 interventions
Group D: Moderate-intensity continuous training + resistance training + weight lossExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Peak Exercise Oxygen Uptake (VO2peak)
VO2peak indexed to body weight (mL/kg/min) will be the co-primary outcome for the trial. VO2peak is a gold-standard measure of aerobic exercise capacity and will be measured by maximal exercise test using a previously established ergometer protocol
Time frame
Baseline, 3months, 6months, and 9months2
Short Physical Performance Battery (SPPB)
SPPB will be a co-primary outcome for the trial. Score ranges from 0 to 12, with 0 indicating the worst performance and 12 indicating the best.
Time frame
Baseline, 3months, 6months, and 9monthsSecondary outcomes
1
Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12)
Health-related quality of life will be assessed using the KCCQ-12 questionnaire. This is a self-administered questionnaire that assesses a patient's perception of their heart failure with regard to the psychological, physical, and socioeconomic aspects of life. Scores range from 0 to 100, where 0 indicates the worst possible health status and 100 indicates the best.
Time frame
Baseline, 3months, 6months, and 9months2
6 Minute Walk Distance (6MWD)
6MWD is a simple and well-validated measure of submaximal exercise capacity and does not require any exercise equipment or advanced training for technicians
Time frame
Baseline, 3months, 6months, and 9months3
General Quality of Life - EQ-5D-5L
Change in general health-related quality of life assessed using the EuroQol 5 Dimension 5 Level (EQ-5D-5L) instrument. The EQ-5D-5L uses a descriptive system to measure health-related quality of life across five key dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on five levels of severity-ranging from no problems (Level 1) to extreme problems or inability to function (Level 5). A respondent's answers generate a five-digit health state profile that reflects their unique combination of responses (e.g., 12345), representing one of 3,125 possible health states. This descriptive system enables consistent and standardized assessment of an individual's health status.
Time frame
Baseline, 3months, 6months, and 9months4
Thirty Second Chair Test
The 30-second chair stand test measures lower-body strength and endurance by counting how many times a person can stand up from a chair and sit down within 30 seconds.
Time frame
Baseline, 3months, 6months, and 9monthsSponsors and contacts
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Source ClinicalTrials.gov