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Physical Activity in Fontan Patients

This study has been completed.
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by (Responsible Party):
Brian McCrindle, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00363363
First received: August 10, 2006
Last updated: August 25, 2013
Last verified: August 2013

August 10, 2006
August 25, 2013
August 2006
June 2008   (final data collection date for primary outcome measure)
Change in the child's moderate-to-vigorous physical activity participation [ Time Frame: From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment) ] [ Designated as safety issue: No ]
  • Change in the child’s moderate-to-vigorous physical activity participation
  • from baseline to end of treatment (12 months) and follow up (6-12 months post-treatment)
Complete list of historical versions of study NCT00363363 on ClinicalTrials.gov Archive Site
  • Increase in health-related physical fitness [ Time Frame: From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment) ] [ Designated as safety issue: No ]
  • Achievement of age-appropriate gross motor skills [ Time Frame: From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment) ] [ Designated as safety issue: No ]
  • Change in the parents' and child's perceptions of physical activity importance, value, appropriateness and competence [ Time Frame: From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment) ] [ Designated as safety issue: No ]
  • Compliance with the intervention [ Time Frame: From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment) ] [ Designated as safety issue: No ]
  • Increase in health-related physical fitness
  • Achievement of age-appropriate gross motor skills
  • Change in the parents’ and child’s perceptions of physical activity importance, value, appropriateness and competence
  • Compliance with the intervention
Not Provided
Not Provided
 
Physical Activity in Fontan Patients
Identifying Determinants and Optimizing Rehabilitation of Physical Activity for Children After the Fontan Procedure

The purpose of this study is to determine which is the most effective intervention for increasing lifestyle physical activity in Fontan patients: an education (stage of change) intervention or a physical activity (mastery experience) intervention.

Over 100,000 Canadian children are living with congenital heart defects and approximately 1.5% of them have a univentricular heart. The Fontan procedure allows children with functionally univentricular hearts to live relatively normal lives. However, the cardiopulmonary physiology remains abnormal and chronic complications, including myocardial dysfunction, arrhythmias, pathway abnormalities, hepatic dysfunction, obstruction of the ventricular outflow tract or pulmonary veins, and pulmonary arteriovenous malformations may significantly reduce maximal exercise capacity and quality of life. Quality of life and life-long heart health are, therefore, critically important for Fontan patients as their survival depends on the continued functioning of an already sub-normal cardiopulmonary physiology.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Heart Defects, Congenital
  • Behavioral: Physical Activity
    Children in this arm of the study will be provided with specific activities to be completed on most days of the week. The selected activities will be based on the child's interests and results of the baseline measures of health-related PA, MVPA and gross motor skill. The resources and facilities available to the family and season of the year will also influence the choice of activities. The frequency and duration of the required activities will be gradually increased until the child's baseline MVPA has been increased by a minimum of 30 minutes per day, most days of the week. Once that increase is achieved, the activities will be modified to maintain and reinforce the higher PA level.
  • Behavioral: Education
    Children in this arm of the study will be provided with puzzles, stories and games to be completed each week. The selected activities will be based on the child's interests and designed to increase the child's knowledge of activity options, perceptions of activity benefits, self-confidence for activity participation and motivation for daily activity. The activities introduced will vary with the resources available to the family and the season of the year, and will include information about healthy eating, injury prevention, and healthy lifestyle options.
  • Experimental: 1
    Intervention: Behavioral: Physical Activity
  • Active Comparator: 2
    Intervention: Behavioral: Education
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
May 2009
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • have undergone a successful Fontan procedure prior to 5 years of age
  • 6 to 10 years of age at the start of the study
  • sufficient cardiopulmonary function (based on pulmonary function tests prior to the standardized cardiorespiratory exercise test) for safe participation in moderate to vigorous physical activity

Exclusion Criteria:

  • disabilities or medical conditions that may influence physical activity participation.
Both
6 Years to 10 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00363363
1000008413
Yes
Brian McCrindle, The Hospital for Sick Children
The Hospital for Sick Children
Heart and Stroke Foundation of Ontario
Principal Investigator: Brian McCrindle, MD The Hospital for Sick Children, Toronto Canada
The Hospital for Sick Children
August 2013

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