Clinical Trial: Optimizing Health Among Children With Congenital Heart Defects

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: The Hospital for Sick Children

Current Primary Outcome: Difference in change of measured moderate-to-vigorous physical activity (MVPA) between groups [ Time Frame: Baseline, 4, 8 and 12 month timepoints ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Gross motor skill [ Time Frame: Baseline, 4, 8 and 12 month timepoints ]
  • Psychosocial variables [ Time Frame: Baseline, 4, 8 and 12 month timepoints ]
  • Health-related fitness [ Time Frame: Baseline, 4, 8 and 12 month timepoints ]


Original Secondary Outcome: Same as current

Information By: The Hospital for Sick Children

Dates:
Date Received: September 9, 2009
Date Started: July 2009
Date Completion:
Last Updated: August 25, 2013
Last Verified: August 2013