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Optimizing Health Among Children With Congenital Heart Defects

25 augusti 2013 uppdaterad av: Brian McCrindle, The Hospital for Sick Children

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

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

172

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Kanada
    • Ontario
      • Toronto, Ontario, Kanada
        • The Hospital for Sick Children

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

4 år till 11 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Grupp 1
Beteende: 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.
Beteende: 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.
Aktiv komparator: Grupp 2
Beteende: 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.
Beteende: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Difference in change of measured moderate-to-vigorous physical activity (MVPA) between groups
Tidsram: Baseline, 4, 8 and 12 month timepoints
Baseline, 4, 8 and 12 month timepoints

Sekundära resultatmått

Resultatmått
Tidsram
Gross motor skill
Tidsram: Baseline, 4, 8 and 12 month timepoints
Baseline, 4, 8 and 12 month timepoints
Psychosocial variables
Tidsram: Baseline, 4, 8 and 12 month timepoints
Baseline, 4, 8 and 12 month timepoints
Health-related fitness
Tidsram: Baseline, 4, 8 and 12 month timepoints
Baseline, 4, 8 and 12 month timepoints

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

The Hospital for Sick Children

Utredare

  • Huvudutredare: Brain W McCrindle, MD, The Hospital for Sick Children

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juli 2009

Primärt slutförande (Faktisk)

1 december 2011

Avslutad studie (Faktisk)

1 juni 2012

Studieregistreringsdatum

Först inskickad

9 september 2009

Först inskickad som uppfyllde QC-kriterierna

9 september 2009

Första postat (Uppskatta)

10 september 2009

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

27 augusti 2013

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

25 augusti 2013

Senast verifierad

1 augusti 2013

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 1000012482

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