Physical Activity in Fontan Patients

Sponsor

The Hospital for Sick Children (Other)

Overall Status

Completed

CT.gov ID

NCT00363363

Collaborator

Heart and Stroke Foundation of Ontario (Other)

Enrollment

Location

Arms

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Defects, Congenital	Behavioral: Physical Activity Behavioral: Education	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2006

Actual Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	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.
Active Comparator: 2	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.

Arm

Intervention/Treatment

Experimental: 1

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.

Active Comparator: 2

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.

Outcome Measures

Primary Outcome Measures

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

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 10 Years

Sexes Eligible for Study:

All

Accepts 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