Clinical trial NCT00974688: Optimizing Health Among Children With Congenital Heart Defects
Official title: Optimizing Health Among Children With Congenital Heart Defects Through Rehabilitation Focused on Physical Activity Determinants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Defects
Keywords: Congenital
physical activity participation
Moderate-to-vigorous physical activity
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2009-09-10
Enrollment: 172
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* Successful repair of one of the following congenital heart defects: transcatheter device closure of atrial septal defect (ASD), arterial switch repair of transposition of the great arteries (TGA), surgical repair of tetralogy of Fallot (TOF), or Fontan procedure for a functionally univentricular heart (UVH).
* At least one year after most recent open heart surgery.
* 4 to 11 years of age and attending elementary school at first study visit.

Exclusion Criteria:

* Identification of exercise contraindications/limitations by the responsible cardiologist.
* Other disabilities or medical conditions that may influence PAP. Children who achieve 90 minutes of MVPA on 5 or more days per week during the baseline assessment will be excluded from the intervention phase. The study interventions are not designed to increase MVPA among children who already achieve the Health Canada guidelines for PAP.

Primary outcomes:
measure: Difference in change of measured moderate-to-vigorous physical activity (MVPA) between groups
timeFrame: Baseline, 4, 8 and 12 month timepoints
Secondary outcomes:
measure: Gross motor skill
timeFrame: Baseline, 4, 8 and 12 month timepoints
measure: Psychosocial variables
timeFrame: Baseline, 4, 8 and 12 month timepoints
measure: Health-related fitness
timeFrame: Baseline, 4, 8 and 12 month timepoints
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Brain W McCrindle, MD
role: PRINCIPAL_INVESTIGATOR
References: