Physical Activity in Fontan Patients

August 25, 2013 updated by: Brian McCrindle, The Hospital for Sick Children

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment)

Secondary Outcome Measures

Outcome Measure
Time Frame
Increase in health-related physical fitness
Time Frame: From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment)
From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment)
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)
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
Time Frame: From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment)
From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment)
Compliance with the intervention
Time Frame: From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment)
From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Collaborators

Heart and Stroke Foundation of Ontario

Investigators

  • Principal Investigator: Brian McCrindle, MD, The Hospital for Sick Children, Toronto Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

August 10, 2006

First Submitted That Met QC Criteria

August 10, 2006

First Posted (Estimate)

August 15, 2006

Study Record Updates

Last Update Posted (Estimate)

August 27, 2013

Last Update Submitted That Met QC Criteria

August 25, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000008413

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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