Physical Activity in Fontan Patients

This study has been completed.
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by (Responsible Party):
Brian McCrindle, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00363363
First received: August 10, 2006
Last updated: August 25, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Heart Defects, Congenital
Behavioral: Physical Activity
Behavioral: Education
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Identifying Determinants and Optimizing Rehabilitation of Physical Activity for Children After the Fontan Procedure

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Increase in health-related physical fitness [ Time Frame: From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Compliance with the intervention [ Time Frame: From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment) ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: August 2006
Study Completion Date: May 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   6 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363363

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Heart and Stroke Foundation of Ontario
Investigators
Principal Investigator: Brian McCrindle, MD The Hospital for Sick Children, Toronto Canada
  More Information

No publications provided

Responsible Party: Brian McCrindle, Staff Cardiologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00363363     History of Changes
Other Study ID Numbers: 1000008413
Study First Received: August 10, 2006
Last Updated: August 25, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
Pediatrics
Fontan Procedure
Physical Activity
Physical Fitness
Congenital Heart Defects
exercise rehabilitation

Additional relevant MeSH terms:
Congenital Abnormalities
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on August 19, 2014