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Home Exercise And Resiliency Training (Heart) Club

Recruiting
19 years of age
Both
Phase N/A

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Overview

The purpose of this research study is to evaluate the impact of a telemedicine-based structured home exercise program on frailty and exercise capacity in individuals with Fontan heart physiology, demonstrate that a telemedicine exercise program reduces socioeconomic and geographic barriers to access to exercise training, and to explore the impact of a structured exercise program on markers of Fontan-associated liver disease.

Description

This study will require two in-person visits to the exercise physiology lab as well as virtual follow-up visits. Visit one will require participants to complete a cardiopulmonary exercise test (CPET), liver ultrasound, 6-minute walk, grip strength test, arm circumference measure, body composition analysis, anthropometrics measurement, surveys and a biomarker blood sample collection. The second in-person visit will require participants to complete a final cardiopulmonary exercise test, liver ultrasound, 6-minute walk, grip strength test and arm circumference, biomarker blood sample and final survey.

Eligibility

Inclusion Criteria:

  • Males and females with Fontan physiology
  • 19 years old at age of enrollment

Exclusion Criteria:

  • Height less than 130 centimeter (cm)
  • Pregnancy or the plan to become pregnant during the study period
  • Current intravenous inotropic drugs
  • Severe ventricular dysfunction assessed qualitatively by clinical echocardiography within six months prior to enrollment
  • Severe valvar regurgitation, ventricular outflow obstruction, or aortic arch obstruction assessed by clinical echocardiography within six months prior to enrollment
  • History of arrhythmia with exercise (excluding isolated supraventricular or ventricular ectopy without symptoms)
  • Inability to complete exercise testing at baseline screening
  • Noncardiac medical, psychiatric, and/or social disorder that would prevent successful completion of planned study testing or would invalidate its results

Study details

Fontan Physiology, Frailty

NCT05543733

University of Michigan

14 May 2024

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