Clinical trial NCT02004756: Mechanisms of Dysfunction and the Influence of Exercise on Cardiac and Musculoskeletal Function
Official title: Mechanisms of Dysfunction and the Influence of Exercise on Cardiac and Musculoskeletal Function in Children After the Fontan Procedure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Congenital Heart Disease
Keywords: pediatric
fontan
congenital heart disease
cardiac and musculoskeletal funion
cardiac and/or musculoskeletal metabolism
exercise training intervention
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2013-12-09
Enrollment: 10
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiac and skeletal function and metabolism
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Brian McCrindle, MD
role: PRINCIPAL_INVESTIGATOR
References: