Clinical trial NCT00363363: Physical Activity in Fontan Patients
Official title: Identifying Determinants and Optimizing Rehabilitation of Physical Activity for Children After the Fontan Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Defects, Congenital
Keywords: Pediatrics
Fontan Procedure
Physical Activity
Physical Fitness
Congenital Heart Defects
exercise rehabilitation
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Ontario
First posted: 2006-08-15
Enrollment: 64
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the child's moderate-to-vigorous physical activity participation
timeFrame: From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment)
Secondary outcomes:
measure: Increase in health-related physical fitness
timeFrame: From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment)
measure: Achievement of age-appropriate gross motor skills
timeFrame: From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment)
measure: Change in the parents' and child's perceptions of physical activity importance, value, appropriateness and competence
timeFrame: From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment)
measure: Compliance with the intervention
timeFrame: From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Brian McCrindle, MD
role: PRINCIPAL_INVESTIGATOR
References: