Recruiting
Phase 2
Phase 3

Remote Exercise Training

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT07223242

Conditions

HFpEF - Heart Failure With Preserved Ejection Fraction

Diabetic Cardiomyopathies

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Moderate-intensity continuous training (MCT)

Resistance training

Weight loss

Study Details

Brief summary:

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.

Conditions

HFpEF - Heart Failure With Preserved Ejection Fraction

Diabetic Cardiomyopathies

Study ID

NCT07223242

Start date

Feb 18, 2025

Status verified date

Oct, 2025

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age>= 18 yrs
2. LVEF (Left Ventricular Ejection Fraction) >= 50%
3. History of HFpEF or at risk of HFpEF

1. HFpEF diagnosis based on:- -HF hospitalization within 12 months-

  • NT-proBNP >360 pg/mL
2. Risk of HFpEF based on:-

  • >2 risk factors (h/o diabetes, hypertension, obesity, physical inactivity by self-report)
4. SPPB < 10 or VO2<60th percentile
5. BMI >=28 (for randomization in phase II)
6. Able to use cell phone and mobile application

Exclusion Criteria:

1. Hospitalization 1 month prior to baseline visit
2. History of recurrent falls
3. eGFR (Estimated Glomerular Filtration Rate) <20ml/min/1.73m
4. Active changes in HF therapies over 2 weeks prior to baseline visit
5. Inability participate in exercise training therapy
6. Inability to perform CPET (Cardiopulmonary Exercise Testing) testing
7. Severe left side valvular heart disease
8. End stage pulmonary disease, requiring continuous supplemental oxygen
9. Major surgery within 3 months of screening or major elective surgery during the duration of the study.
10. Unstable weight defined by >5% change in body weight in last 30 days before first study visit.
11. Pregnancy

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Moderate-intensity continuous training (MCT)

Tailored moderate-intensity exercise training video with weekly virtual meetings with a coach

Resistance training

Resistance training videos assigned to patient

Weight loss

Initiation/intensification of weight loss medications, such as semaglutide or tirzepatide

Primary outcome measure

  • Peak Exercise Oxygen Uptake (VO2peak) [ Time Frame: Baseline, 3months, 6months, and 9months ]
  • Short Physical Performance Battery (SPPB) [ Time Frame: Baseline, 3months, 6months, and 9months ]

Central Contacts and Locations

Locations

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75209

Contacts

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Oct 31, 2025

Last verified

Oct, 2025

Keywords

  • Diabetic cardiomyopathy
  • Remote exercise training
  • Weight loss
  • Rehab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2025-10-31.