Tailored exercise training for adults with HFpEF

Tailored Exercise Training Study Among Adults With HFpEF

This program will test remote, personalized exercise and lifestyle plans to see if they help adults with HFpEF or at risk of it improve how much they can exercise and their muscle health.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Texas Southwestern Medical Center (other)
• Locations: 1 site (Dallas, Texas)
• Trial ID: NCT07223242 on ClinicalTrials.gov

What this trial studies

This Phase 2/3 interventional study delivers home-based moderate-intensity continuous training (MCT) through tailored exercise videos on mobile devices with weekly virtual support and measures effects on exercise capacity and skeletal muscle composition. In Phase I, 120 participants undergo three months of remote MCT with in-person baseline and follow-up testing including CPET and physical performance measures. Participants who meet randomization criteria (including BMI ≥28) enter Phase II to compare four lifestyle interventions such as resistance training and weight-loss programs for their effects on peak VO2, SPPB, muscle composition, and quality of life. The design emphasizes remote delivery to overcome logistical and cost barriers of supervised exercise while retaining key in-person assessments at the study center.

Who should consider this trial

Good fit: Adults aged 18 or older with LVEF ≥50% who have HFpEF or are at risk (multiple cardiometabolic risk factors), with reduced physical performance (SPPB <10 or low VO2) and who can use a smartphone/app are ideal candidates.

Not a fit: Patients with recent hospitalization, recurrent falls, severe valvular disease, end-stage pulmonary disease requiring continuous oxygen, very low kidney function (eGFR <20), or who cannot exercise or complete CPET are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, remote tailored exercise programs could improve exercise capacity, muscle health, and quality of life for adults with HFpEF while making therapy easier to access.

How similar studies have performed: Supervised exercise has previously improved exercise capacity and quality of life in HFpEF, but remotely delivered, tailored programs are less tested though early work suggests potential benefit.

Eligibility criteria

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

Where this trial is running

Dallas, Texas

• University of Texas Southwestern Medical Center — Dallas, Texas, United States (RECRUITING)

Conditions: HFpEF - Heart Failure With Preserved Ejection Fraction, Diabetic Cardiomyopathies, Diabetic cardiomyopathy, Remote exercise training, Weight loss, Rehab