NCT00363363

Physical Activity in Fontan Patients

Identifying Determinants and Optimizing Rehabilitation of Physical Activity for Children After the Fontan Procedure

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 6 Years – 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Defects, Congenital

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-08-01
• Primary completion: 2008-06-01
• Completion: 2009-05-01
• First posted: 2006-08-15
• Last updated: 2013-08-27

Locations

1 site across 1 country: Canada