NCT02004756

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

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 10 Years – 16 Years
• Healthy volunteers: Accepted

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.

Conditions

• Congenital Heart Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-01-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2013-12-09
• Last updated: 2016-02-01

Locations

1 site across 1 country: Canada