Mechanisms of Dysfunction and the Influence of Exercise on Cardiac and Musculoskeletal Function

Study Overview
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Brief Summary
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Primary Objective: To determine if impairments in cardiac and musculoskeletal function and metabolism exist in Fontan children. Secondary Objectives: To determine if impairments do exist, are they related to exercise capacity. To determine if a 12-week exercise training intervention improves cardiac and/or musculoskeletal metabolism. Hypothesis: The investigators hypothesize that abnormalities in cardiac and skeletal function are evident, influence exercise capacity, and can be improved with exercise training.

Detailed Description
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This proposed research provides an interdisciplinary approach to understanding exercise intolerance by examining cardiac and musculoskeletal metabolism in a unique cohort of children with congenital heart disease. Study findings may more importantly lead to evidence-based exercise interventions that promote improvements in overall physical health, quality of life, and functional status for Fontan children. Furthermore, this pilot study will lead to the development of a novel research protocol which may be applied to larger Fontan and other congenital heart disease cohorts. This study will also provide preliminary data to develop and conduct a larger clinical research project.

Official Title
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Mechanisms of Dysfunction and the Influence of Exercise on Cardiac and Musculoskeletal Function in Children After the Fontan Procedure

Conditions
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Congenital Heart Disease

Intervention / Treatment
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* Other: Exercise Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fontan Patients: Patients who have had the Fontan cardiac procedure 10-16 years of age Written Informed Consent Healthy Controls: 10 - 16 years of age Written Informed Consent Exclusion Criteria: Fontan Patients: Contraindication to exercise Physically active (i.e., ≥ 60 minute of moderate-vigorous activity) (Strong et al., 2005) Patients in whom MRI is contraindicated (e.g. pacemaker, ocular metal, claustrophobia, tattoos) Patients with a known allergy to gadolinium. Patients with a history of allergic disposition or have anaphylactic reactions Moderate-to-severe renal impairment (defined as having a GFR/ eGFR < 60 mL/min) Have Sickle Cell anemia Known pregnancy, or breast feeding Patient is uncooperative during a MRI without sedation or anesthesia Healthy Controls: Contraindication to exercise Physically active (i.e., ≥ 60 minute of moderate-vigorous activity) (Strong et al., 2005) Patients in whom MRI is contraindicated (e.g. pacemaker, ocular metal, claustrophobia, tattoos, pregnancy) Patient is uncooperative during a MRI without sedation or anesthesia

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fontan Patients<br>Fontan patients who are monitored at the Hospital for Sick Children (SickKids) will undergo an exercise program | Other: Exercise Program<br>* The Fontan cohort will subsequently complete a 12-week moderate intensity exercise intervention whereby individualized activity-based home interventions will be prescribed (i.e., sample activities: walking, jogging, swimming, cycling, soccer). More specifically, individualized weekly exercise programs for participants will be provided incorporating two specific exercise components.<br>|
| No Intervention: Healthy Controls<br>Healthy age-matched adolescents | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac and skeletal function and metabolism | Blood oxygen level dependent functional magnetic resonance imaging (BOLD fMRI), and 31P-MRS will allow for the precise measurement of cardiac and musculoskeletal function, circulatory perfusion and vascular reactivity, and aerobic and anaerobic metabolism, respectively. Cardiac function will be examined via MRI and exercise echocardiography. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, fontan, congenital heart disease, cardiac and musculoskeletal funion, cardiac and/or musculoskeletal metabolism, exercise training intervention