Home Exercise And Resiliency Training (Heart) Club

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Home Exercise And Resiliency Training (HEART) Club: A Virtual Care at Home Program to Reduce Frailty for Adults With Fontan Circulation

Conditions
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Fontan Physiology, Frailty

Intervention / Treatment
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* Behavioral: Home exercise program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females with Fontan physiology 18 years old at 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home exercise program<br> | Behavioral: Home exercise program<br>* Participants will complete a 6-month prescription telemedicine-based structured home exercise program. Baseline information will be used to develop a personalized home exercise program. This program will involve downloading the MyDataHelps application on a mobile device to securely collect wearable device information like step counts, activity minutes, and heart rate. Additionally, participants will have multiple virtual visits as well as the 2 in-person visits.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Frailty score by the Fried frailty instrument | The questionnaire evaluates five components of the frailty syndrome (weakness, slowness, shrinkage, exhaustion, and diminished physical activity). Sum of the components will have a possible score of 0-5: not frail (score 0), pre-frail (score 1-2), frail (score great or equal to 3), undetermined (missing component). | day 1 (baseline), week 26 (final visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 7-day average step count over 6 month period |  | Baseline, 6 months | 
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - 29 | This survey has 29 items across the following domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, ability to participate in social roles and activities, cognitive function on a scale of 1 (worst) to 5 (best), and pain intensity (on a scale ranging from 0 (no pain) to 10 (worst pain imaginable). | day 1 (baseline), week 26 (final visit) | 
| Change in 6-minute walk distance |  | day 1 (baseline), week 26 (final visit) | 
| Change in peak oxygen consumption | This is measured during a Cardiopulmonary Exercise Testing (CPET) test measured in milliliters per minute (mL/min). | day 1 (baseline), week 26 (final visit) | 
| Change in oxygen consumption at anaerobic threshold | This is measured during a CPET. | day 1 (baseline), week 26 (final visit) | 
| Change in liver stiffness measured by ultrasound | This is measured during ultrasound, units meters per second (m/sec) | day 1 (baseline), week 26 (final visit) | 
| Change in alpha fetoprotein (AFP) | This is a blood sample. | day 1 (baseline), week 26 (final visit) | 
| Change in Aspartate Transferase (AST) | This is a blood sample. | day 1 (baseline), week 26 (final visit) | 
| Change in Alanine Aminotransferase (ALT) | This is a blood sample. | day 1 (baseline), week 26 (final visit) | 
| Change in platelets | This is a blood sample. | day 1 (baseline), week 26 (final visit) | 
| Change in Gamma-glutamyl Transferase (GGT) | This is a blood sample. | day 1 (baseline), week 26 (final visit) | 
| Change in Enhanced Liver Fibrosis (Elf) Score number | This is a blood sample. | day 1 (baseline), week 26 (final visit) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise program, Liver stiffness