Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-01-02 @ 4:01 AM
Study NCT ID:
NCT02004756
Status:
TERMINATED
Last Update Posted:
2016-02-01
First Post:
2013-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanisms of Dysfunction and the Influence of Exercise on Cardiac and Musculoskeletal Function
Sponsor:
The Hospital for Sick Children
Organization:
Study Overview
Official Title:
Mechanisms of Dysfunction and the Influence of Exercise on Cardiac and Musculoskeletal Function in Children After the Fontan Procedure
Status:
TERMINATED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Feasibility issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: