RightFit
RecruitingPhase 2 / Phase 3

Tailored Exercise Training Study Among Adults With HFpEF

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 months
  • Procedures mentioned: Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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

Study sites (1)

TX