Physical Activity in Fontan Patients

Phase 3

Completed

• Conditions: Heart Defects, Congenital
• Interventions: Behavioral: Physical Activity; Behavioral: Education

• Registration Number: NCT00363363
• Lead Sponsor: The Hospital for Sick Children

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.

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-08-10
• Study First Submitted QC: 2006-08-10
• Study First Posted: 2006-08-15
• Primary Completion: 2008-06
• Study Completion: 2009-05
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-25
• Last Update Posted: 2013-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

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Exclusion Criteria

• disabilities or medical conditions that may influence physical activity participation.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Physical Activity	-
2	Education	-

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
Increase in health-related physical fitness	From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment)
Achievement of age-appropriate gross motor skills	From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment)
Change in the parents' and child's perceptions of physical activity importance, value, appropriateness and competence	From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment)
Compliance with the intervention	From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment)

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada