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

NCT ID: NCT02004756

Last Updated: 2016-02-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2015-04-30

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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fontan Patients

Fontan patients who are monitored at the Hospital for Sick Children (SickKids) will undergo an exercise program

Group Type: EXPERIMENTAL

Exercise Program

Intervention Type: OTHER

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.

Healthy Controls

Healthy age-matched adolescents

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Brian McCrindle

Staff Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian McCrindle, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000016650

Identifier Type: -

Identifier Source: org_study_id