Tailored Exercise Training Study Among Adults With HFpEF
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Moderate-intensity continuous training (MCT), Resistance training, Weight loss.
- Who it may be relevant to
- Registry conditions: HFpEF - Heart Failure With Preserved Ejection Fraction, Diabetic Cardiomyopathies. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Heart failure (HF) portends substantial morbidity, mortality, and health care costs in the United States and the prevalence of heart failure with preserved ejection fraction (HFpEF) relative to HF with reduced ejection fraction (HFrEF) has been increasing. HFpEF is associated with a high morbidity and mortality burden. There are limited pharmacological options available for the treatment of HFpEF. It is now recognized as a systemic, multi-organ, geriatric syndrome, with exercise intolerance (EI) and functional impairment as the key clinical manifestations. 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 the effects of four different lifestyle interventions on exercise capacity.
The study will be carried out in two phases. In Phase I, 120 participants will undergo three months of home-based moderate-intensity continuous training (MCT), using tailored exercise videos on a mobile or tablet. Participants will also have weekly virtual meetings with a coach to discuss their progress. This will be followed by 3 months of no intervention, to assess the effects of detraining.
In Phase II (at the 6-month mark), 100 participants will be randomized to one of four extended training strategies for 3 months -(i) MCT alone; (ii) MCT plus resistance training; (iii) MCT plus weight loss, or (iv) MCT plus resistance training and weight loss.
The co-primary outcomes are (1) peak VO2, and (2) short physical performance battery score. In addition, participants will undergo CT chest/abdomen/pelvis at 3 months and 6 months to assess change in skeletal muscle composition with MCT
Interventions
- Behavioral Moderate-intensity continuous training (MCT)
Tailored moderate-intensity exercise training video with weekly virtual meetings with a coach - Behavioral Resistance training
Resistance training videos assigned to patient - Drug Weight loss
Initiation/intensification of weight loss medications, such as semaglutide or tirzepatide
Primary outcome measures
- Peak Exercise Oxygen Uptake (VO2peak) [Time frame: Baseline, 3months, 6months, and 9months]
- Short Physical Performance Battery (SPPB) [Time frame: Baseline, 3months, 6months, and 9months]
Secondary outcome measures (12)
- Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12) [Time frame: Baseline, 3months, 6months, and 9months]
- 6 Minute Walk Distance (6MWD) [Time frame: Baseline, 3months, 6months, and 9months]
- General Quality of Life - EQ-5D-5L [Time frame: Baseline, 3months, 6months, and 9months]
- Thirty Second Chair Test [Time frame: Baseline, 3months, 6months, and 9months]
- Fried Frailty Phenotype [Time frame: Baseline, 3months, 6months, and 9months]
- Resting cardiac output [Time frame: Baseline, 3months, 6months, and 9months]
- Exercise cardiac output [Time frame: Baseline, 3months, 6months, and 9months]
- Intramyocellular fat [Time frame: Baseline, 3months, 6months, and 9months]
- Intermuscular Adipose Tissue (IMAT) [Time frame: Baseline, 3months, 6months, and 9months]
- Subcutaneous adiposity deposits [Time frame: Baseline, 3months, 6months, and 9months]
- Visceral Adiposity Deposits [Time frame: Baseline, 3months, 6months, and 9months]
- Pericardial Adiposity Deposits [Time frame: Baseline, 3months, 6months, and 9months]
Eligibility criteria
Inclusion criteria
- 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-
- NT-proBNP >360 pg/mL
- Risk of HFpEF based on:-
- >2 risk factors (h/o diabetes, hypertension, obesity, physical inactivity by self-report)
- SPPB < 10 or VO2<60th percentile
- BMI >=28 (for randomization in phase II)
- Able to use cell phone and mobile application
Exclusion criteria
- 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
- Inability participate in exercise training therapy
- Inability to perform CPET (Cardiopulmonary Exercise Testing) testing
- Severe left side valvular heart disease
- End stage pulmonary disease, requiring continuous supplemental oxygen
- Major surgery within 3 months of screening or major elective surgery during the duration of the study.
- Unstable weight defined by >5% change in body weight in last 30 days before first study visit.
- Pregnancy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Texas Southwestern Medical Center — Dallas
Identifiers
NCT: NCT07223242 · STU-2024-0592