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

Phase 2TerminatedNCT02004756

The Hospital for Sick Children10 enrolled

Overview

Primary Objective: To determine if impairments in cardiac and musculoskeletal function and metabolism exist in Fontan children. Secondary Objectives: 1. To determine if impairments do exist, are they related to exercise capacity. 2. 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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Congenital Heart Disease

Interventions

Exercise ProgramOTHER

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.

Eligibility

Sex: ALLMin age: 10 YearsMax age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Fontan Patients: 1. Patients who have had the Fontan cardiac procedure 2. 10-16 years of age 3. Written Informed Consent Healthy Controls: 1. 10 - 16 years of age 2. Written Informed Consent Exclusion Criteria: Fontan Patients: 1. Contraindication to exercise 2. Physically active (i.e., ≥ 60 minute of moderate-vigorous activity) (Strong et al., 2005) 3. Patients in whom MRI is contraindicated (e.g. pacemaker, ocular metal, claustrophobia, tattoos) 4. Patients with a known allergy to gadolinium. 5. Patients with a history of allergic disposition or have anaphylactic reactions 6. Moderate-to-severe renal impairment (defined as having a GFR/ eGFR \< 60 mL/min) 7. Have Sickle Cell anemia 8. Known pregnancy, or breast feeding 9. Patient is uncooperative during a MRI without sedation or anesthesia Healthy Controls: 1. Contraindication to exercise 2. Physically active (i.e., ≥ 60 minute of moderate-vigorous activity) (Strong et al., 2005) 3. Patients in whom MRI is contraindicated (e.g. pacemaker, ocular metal, claustrophobia, tattoos, pregnancy) 4. Patient is uncooperative during a MRI without sedation or anesthesia

Locations (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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.

Time frame: 1 day

Data from ClinicalTrials.gov

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