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Completed

NCT Number: NCT00363363

Physical Activity in Fontan Patients

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.

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Key information

Conditions

Heart Defects, Congenital Behavior Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Diseases Motor Activity

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical activity

Behavioral

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.

Education

Behavioral

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.

Primary outcomes

  1. Change in the child's moderate-to-vigorous physical activity participation

    Time frame: From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment)

Secondary outcomes

  1. Increase in health-related physical fitness

    Time frame: From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment)

  2. Achievement of age-appropriate gross motor skills

    Time frame: From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment)

  3. Change in the parents' and child's perceptions of physical activity importance, value, appropriateness and competence

    Time frame: From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment)

  4. Compliance with the intervention

    Time frame: From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment)

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Heart and Stroke Foundation of Ontario

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Aug 15, 2006
Registry last updated
Aug 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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