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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

Tracking Information
First Submitted Date  ICMJE August 25, 2013
First Posted Date  ICMJE December 9, 2013
Last Update Posted Date February 1, 2016
Study Start Date  ICMJE January 2010
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02004756 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mechanisms of Dysfunction and the Influence of Exercise on Cardiac and Musculoskeletal Function
Official Title  ICMJE Mechanisms of Dysfunction and the Influence of Exercise on Cardiac and Musculoskeletal Function in Children After the Fontan Procedure
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Congenital Heart Disease
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Fontan Patients
    Fontan patients who are monitored at the Hospital for Sick Children (SickKids) will undergo an exercise program
    Intervention: Other: Exercise Program
  • No Intervention: Healthy Controls
    Healthy age-matched adolescents
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 29, 2016)
10
Original Estimated Enrollment  ICMJE
 (submitted: December 2, 2013)
25
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02004756
Other Study ID Numbers  ICMJE 1000016650
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Brian McCrindle, The Hospital for Sick Children
Study Sponsor  ICMJE The Hospital for Sick Children
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Brian McCrindle, MD The Hospital for Sick Children
PRS Account The Hospital for Sick Children
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP