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

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.

Study Overview

• Status: Terminated
• Conditions: Congenital Heart Disease
• Intervention / Treatment: Other: Exercise Program

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5V1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Brian McCrindle, MD, The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: August 25, 2013
• First Submitted That Met QC Criteria: December 2, 2013
• First Posted (Estimate): December 9, 2013

Study Record Updates

• Last Update Posted (Estimate): February 1, 2016
• Last Update Submitted That Met QC Criteria: January 29, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: pediatric; congenital heart disease; fontan; cardiac and musculoskeletal funion; cardiac and/or musculoskeletal metabolism; exercise training intervention
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: 1000016650