Tailored Exercise Training Study Among Adults With HFpEF

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT07223242
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Diabetic Cardiomyopathies
  • HFpEF - Heart Failure With Preserved Ejection Fraction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Moderate-intensity continuous training (MCT) — BEHAVIORAL
    Tailored moderate-intensity exercise training video with weekly virtual meetings with a coach
  • Resistance training — BEHAVIORAL
    Resistance training videos assigned to patient
  • Weight loss — DRUG
    Initiation/intensification of weight loss medications, such as semaglutide or tirzepatide

Study Details

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.

Key Dates

Start date
Feb 18, 2025
Status verified
Oct 2025
Primary completion
Dec 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Moderate-intensity continuous training (MCT)
    Tailored moderate-intensity exercise training video with weekly virtual meetings with a coach
  • Experimental: Moderate-intensity continuous training + weight loss
    Tailored moderate-intensity exercise training videos with weekly virtual meetings with a coach + initiation/intensification of pharmacological weight loss
  • Experimental: Moderate-intensity continuous training + resistance training
    Tailored moderate-intensity exercise training videos with weekly virtual meetings with a coach + tailored resistance training videos
  • Experimental: Moderate-intensity continuous training + resistance training + weight loss
    Tailored moderate-intensity exercise training videos with weekly virtual meetings with a coach + tailored resistance training videos + initiation/intensification of pharmacological weight loss

Primary Outcome Measure

Peak Exercise Oxygen Uptake (VO2peak) [ Time Frame: Baseline, 3months, 6months, and 9months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75209
Ambarish Pandey, MD
[email protected]
214-645-9868

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By research site
University of Texas Southwestern Medical Center· Dallas, TX

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