Home Exercise And Resiliency Training (Heart) Club

University of Michigan

Status: Active, not recruiting

Conditions: Fontan Physiology; Frailty

Treatments: Behavioral: Home exercise program

Study type: Interventional

Funder types: Other

Identifiers

NCT05543733

HUM00220044

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

Home exercise program

Experimental group

Treatment:

Behavioral: Home exercise program