Physical Activity in Fontan Patients

Heart Defects, Congenital Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00363363
• Other study ID #: 1000008413
• Status: Completed
• Phase: Phase 3
• First received: August 10, 2006
• Last updated: August 25, 2013
• Start date: August 2006
• Est. completion date: May 2009

Study information

• Verified date: August 2013
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 2009
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 10 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Heart and Stroke Foundation of Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Increase in health-related physical fitness		From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment)	No
Secondary	Achievement of age-appropriate gross motor skills		From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment)	No
Secondary	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)	No
Secondary	Compliance with the intervention		From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment)	No