Physical Activity in Fontan Patients

The Hospital for Sick Children

Status and phase

Completed

Phase 3

Conditions

Heart Defects, Congenital

Treatments

Behavioral: Physical Activity

Behavioral: Education

Study type

Interventional

Funder types

Other

Identifiers

NCT00363363

1000008413

Details and patient eligibility

About

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.

Full 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.

Enrollment

64 patients

Sex

All

Ages

6 to 10 years old

Volunteers

No Healthy Volunteers

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