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Optimizing Health Among Children With Congenital Heart Defects

25 de agosto de 2013 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

172

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

4 años a 11 años (Niño)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Grupo 1
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.
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.
Comparador activo: Grupo 2
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.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Difference in change of measured moderate-to-vigorous physical activity (MVPA) between groups
Periodo de tiempo: Baseline, 4, 8 and 12 month timepoints
Baseline, 4, 8 and 12 month timepoints

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Gross motor skill
Periodo de tiempo: Baseline, 4, 8 and 12 month timepoints
Baseline, 4, 8 and 12 month timepoints
Psychosocial variables
Periodo de tiempo: Baseline, 4, 8 and 12 month timepoints
Baseline, 4, 8 and 12 month timepoints
Health-related fitness
Periodo de tiempo: Baseline, 4, 8 and 12 month timepoints
Baseline, 4, 8 and 12 month timepoints

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de julio de 2009

Finalización primaria (Actual)

1 de diciembre de 2011

Finalización del estudio (Actual)

1 de junio de 2012

Fechas de registro del estudio

Enviado por primera vez

9 de septiembre de 2009

Primero enviado que cumplió con los criterios de control de calidad

9 de septiembre de 2009

Publicado por primera vez (Estimar)

10 de septiembre de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

27 de agosto de 2013

Última actualización enviada que cumplió con los criterios de control de calidad

25 de agosto de 2013

Última verificación

1 de agosto de 2013

Más información

Términos relacionados con este estudio

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Defectos cardíacos congénitos

Ensayos clínicos sobre Information Intervention

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