Physical Activity in Fontan Patients
Primary Purpose
Heart Defects, Congenital
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Physical Activity
Education
Sponsored by
About this trial
This is an interventional treatment trial for Heart Defects, Congenital focused on measuring Pediatrics, Fontan Procedure, Physical Activity, Physical Fitness, Congenital Heart Defects, exercise rehabilitation
Eligibility 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.
Sites / Locations
- The Hospital for Sick Children
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Change in the child's moderate-to-vigorous physical activity participation
Secondary Outcome Measures
Increase in health-related physical fitness
Achievement of age-appropriate gross motor skills
Change in the parents' and child's perceptions of physical activity importance, value, appropriateness and competence
Compliance with the intervention
Full Information
NCT ID
NCT00363363
First Posted
August 10, 2006
Last Updated
August 25, 2013
Sponsor
The Hospital for Sick Children
Collaborators
Heart and Stroke Foundation of Ontario
1. Study Identification
Unique Protocol Identification Number
NCT00363363
Brief Title
Physical Activity in Fontan Patients
Official Title
Identifying Determinants and Optimizing Rehabilitation of Physical Activity for Children After the Fontan Procedure
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
Heart and Stroke Foundation of Ontario
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Defects, Congenital
Keywords
Pediatrics, Fontan Procedure, Physical Activity, Physical Fitness, Congenital Heart Defects, exercise rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
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 Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Increase in health-related physical fitness
Time Frame
From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment)
Title
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)
Title
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)
Title
Compliance with the intervention
Time Frame
From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian McCrindle, MD
Organizational Affiliation
The Hospital for Sick Children, Toronto Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
12. IPD Sharing Statement
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Physical Activity in Fontan Patients
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