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

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02004756
• Other study ID #: 1000016650
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: August 25, 2013
• Last updated: January 29, 2016
• Start date: January 2010
• Est. completion date: April 2015

Study information

• Verified date: January 2016
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 16 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day	No