NCT00974688

Optimizing Health Among Children With Congenital Heart Defects

Optimizing Health Among Children With Congenital Heart Defects Through Rehabilitation Focused on Physical Activity Determinants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 4 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

Quality of life and heart health are intimately connected to childhood physical activity participation (PAP). Physical activity is critical to childhood growth, development, learning, socialization, and quality of life and is an essential component of life-long heart health. Research by the investigators of this study and others has shown that low PAP levels are common among children with heart defects, and that these sedentary lifestyles are not related to exercise capacity, medical status or heart function.

Detailed description

Therefore, we hypothesize that psychosocial factors are important determinants of PAP in this population. Our most recent research with children who have univentricular heart indicates that gross motor skill and psychosocial factors are significant correlates of PAP. Important psychosocial factors include self-efficacy for activity, uncertainty about activity, and inaccurate perceptions of the child's PAP level, options, and abilities. This study seeks to determine whether gross motor skill and psychosocial factors influence PAP among children with a broad spectrum of cardiac defects. It will also determine the optimal changes to clinical care needed to encourage children with heart defects to develop health-related active lifestyles. We propose a prospective, randomized, cross-over preliminary clinical trial utilizing both quantitative and qualitative assessments. Through the cross-over design, each subject will complete both interventions (information, demonstration), with the order of intervention delivery randomly determined. Quantitative assessments will document moderate-to-vigorous physical activity (MVPA), gross motor skill, and health-related fitness. Qualitative assessments will evaluate parent/child anxiety about PAP and psychosocial factors influencing PAP. All factors will be assessed at each data collection point.

Conditions

• Congenital Heart Defects

Interventions

Type	Name	Description
BEHAVIORAL	Information Intervention	The information intervention is designed to ensure that the parent(s) and child have a clear understanding of the range of physical activity opportunities that are appropriate and recommended for the child. The information intervention will be comprised of discussions and written information.
BEHAVIORAL	Demonstration Intervention	The demonstration intervention will be designed to demonstrate to the child and parent(s) specifically what the child is able to do in relation to fitness and motor skill activities. The demonstration intervention will consist of having the child complete a standardized exercise testing protocol on the treadmill, followed by discussions with the child and parent(s) to convey the results of the study testing of fitness and gross motor skill.

Timeline

• Start date: 2009-07-01
• Primary completion: 2011-12-01
• Completion: 2012-06-01
• First posted: 2009-09-10
• Last updated: 2013-08-27

Locations

1 site across 1 country: Canada