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

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ClinicalTrials.gov Identifier: NCT02004756
Recruitment Status : Terminated (Feasibility issues)
First Posted : December 9, 2013
Last Update Posted : February 1, 2016
Sponsor:
Information provided by (Responsible Party):
Brian McCrindle, The Hospital for Sick Children

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.


Condition or disease Intervention/treatment Phase
Congenital Heart Disease Other: Exercise Program Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mechanisms of Dysfunction and the Influence of Exercise on Cardiac and Musculoskeletal Function in Children After the Fontan Procedure
Study Start Date : January 2010
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Cardiac and skeletal function and metabolism [ Time Frame: 1 day ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004756


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5V1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Brian McCrindle, MD The Hospital for Sick Children

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Responsible Party: Brian McCrindle, Staff Cardiologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02004756     History of Changes
Other Study ID Numbers: 1000016650
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: February 1, 2016
Last Verified: January 2016

Keywords provided by Brian McCrindle, The Hospital for Sick Children:
pediatric
fontan
congenital heart disease
cardiac and musculoskeletal funion
cardiac and/or musculoskeletal metabolism
exercise training intervention

Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities