Mechanisms of Dysfunction and the Influence of Exercise on Cardiac and Musculoskeletal Function
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|ClinicalTrials.gov Identifier: NCT02004756|
Recruitment Status : Terminated (Feasibility issues)
First Posted : December 9, 2013
Last Update Posted : February 1, 2016
Primary Objective: To determine if impairments in cardiac and musculoskeletal function and metabolism exist in Fontan children.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Congenital Heart Disease||Other: Exercise Program||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mechanisms of Dysfunction and the Influence of Exercise on Cardiac and Musculoskeletal Function in Children After the Fontan Procedure|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
Experimental: Fontan Patients
Fontan patients who are monitored at the Hospital for Sick Children (SickKids) will undergo an exercise program
Other: Exercise Program
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.
No Intervention: Healthy Controls
Healthy age-matched adolescents
- Cardiac and skeletal function and metabolism [ Time Frame: 1 day ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004756
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5V1X8|
|Principal Investigator:||Brian McCrindle, MD||The Hospital for Sick Children|