Back to resultsMechanisms of Dysfunction and the Influence of Exercise on Cardiac and Musculoskeletal Function
Primary Purpose
Congenital Heart Disease
Status
Terminated
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Exercise Program
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Heart Disease focused on measuring pediatric, fontan, congenital heart disease, cardiac and musculoskeletal funion, cardiac and/or musculoskeletal metabolism, exercise training intervention
Eligibility Criteria
Inclusion Criteria:
Fontan Patients:
- Patients who have had the Fontan cardiac procedure
- 10-16 years of age
- Written Informed Consent
Healthy Controls:
- 10 - 16 years of age
- Written Informed Consent
Exclusion Criteria:
Fontan Patients:
- Contraindication to exercise
- Physically active (i.e., ≥ 60 minute of moderate-vigorous activity) (Strong et al., 2005)
- Patients in whom MRI is contraindicated (e.g. pacemaker, ocular metal, claustrophobia, tattoos)
- Patients with a known allergy to gadolinium.
- Patients with a history of allergic disposition or have anaphylactic reactions
- Moderate-to-severe renal impairment (defined as having a GFR/ eGFR < 60 mL/min)
- Have Sickle Cell anemia
- Known pregnancy, or breast feeding
- Patient is uncooperative during a MRI without sedation or anesthesia
Healthy Controls:
- Contraindication to exercise
- Physically active (i.e., ≥ 60 minute of moderate-vigorous activity) (Strong et al., 2005)
- Patients in whom MRI is contraindicated (e.g. pacemaker, ocular metal, claustrophobia, tattoos, pregnancy)
- Patient is uncooperative during a MRI without sedation or anesthesia
Sites / Locations
- The Hospital for Sick Children
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Fontan Patients
Healthy Controls
Arm Description
Fontan patients who are monitored at the Hospital for Sick Children (SickKids) will undergo an exercise program
Healthy age-matched adolescents
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02004756
First Posted
August 25, 2013
Last Updated
January 29, 2016
Sponsor
The Hospital for Sick Children
1. Study Identification
Unique Protocol Identification Number
NCT02004756
Brief Title
Mechanisms of Dysfunction and the Influence of Exercise on Cardiac and Musculoskeletal Function
Official Title
Mechanisms of Dysfunction and the Influence of Exercise on Cardiac and Musculoskeletal Function in Children After the Fontan Procedure
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
Feasibility issues
Study Start Date
January 2010 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Primary Objective: To determine if impairments in cardiac and musculoskeletal function and metabolism exist in Fontan children.
Secondary Objectives:
To determine if impairments do exist, are they related to exercise capacity.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
Keywords
pediatric, fontan, congenital heart disease, cardiac and musculoskeletal funion, cardiac and/or musculoskeletal metabolism, exercise training intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fontan Patients
Arm Type
Experimental
Arm Description
Fontan patients who are monitored at the Hospital for Sick Children (SickKids) will undergo an exercise program
Arm Title
Healthy Controls
Arm Type
No Intervention
Arm Description
Healthy age-matched adolescents
Intervention Type
Other
Intervention Name(s)
Exercise Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cardiac and skeletal function and metabolism
Description
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.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Fontan Patients:
Patients who have had the Fontan cardiac procedure
10-16 years of age
Written Informed Consent
Healthy Controls:
10 - 16 years of age
Written Informed Consent
Exclusion Criteria:
Fontan Patients:
Contraindication to exercise
Physically active (i.e., ≥ 60 minute of moderate-vigorous activity) (Strong et al., 2005)
Patients in whom MRI is contraindicated (e.g. pacemaker, ocular metal, claustrophobia, tattoos)
Patients with a known allergy to gadolinium.
Patients with a history of allergic disposition or have anaphylactic reactions
Moderate-to-severe renal impairment (defined as having a GFR/ eGFR < 60 mL/min)
Have Sickle Cell anemia
Known pregnancy, or breast feeding
Patient is uncooperative during a MRI without sedation or anesthesia
Healthy Controls:
Contraindication to exercise
Physically active (i.e., ≥ 60 minute of moderate-vigorous activity) (Strong et al., 2005)
Patients in whom MRI is contraindicated (e.g. pacemaker, ocular metal, claustrophobia, tattoos, pregnancy)
Patient is uncooperative during a MRI without sedation or anesthesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian McCrindle, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5V1X8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Mechanisms of Dysfunction and the Influence of Exercise on Cardiac and Musculoskeletal Function
We'll reach out to this number within 24 hrs