- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03479658
Dose-effect of HIIT on Cardiovascular Health of Children
Dose-effect of HIIT on Cardiovascular Health of Children Aged 9 to 10 Years Old Participating in a School Based Multidisciplinary Intervention Program: a Pilot Study
An adequate physical activity level has important effects on cardiovascular health of children. However, the scientific literature suggests that few children meet the physical activity recommendations to obtain these cardiovascular benefits which may have immediate and long term consequences in public health. High intensity interval training (HIIT) has emerged as an effective strategy for improving physical and mental health in children. To note that HIIT can be completed in a shorter period of time and its results in physical health seem to be equivalent to those obtained in longer sessions of traditional aerobic training. However, there is no information about the dose of HIIT needed to obtain significant effects on cardiovascular health of children.
The adoption of healthy dietary habits is also important in the prevention of obesity and cardiovascular diseases.
School-based programs including physical activity and nutritional education have been recommended as important components of programs aiming to prevent obesity and cardiovascular diseases.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Navarra
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Pamplona, Navarra, España, 31008
- Department of Health Sciences, Universidad Pública de Navarra
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
All school children able to attend the physical education sessions of the school
-
Exclusion Criteria:
- Children with medical condition that limits physical activity
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: HIIT two sessions
Two sessions per week of HIIT + nutritional education (1 session/week)
|
Two schools with four classes/groups of 4th degree of children will participate in the pilot study (i.e., age of children 9-10 years old).
One of them has two physical education (PE) sessions per week and the other has only one PE session per week.
In the school with two PE sessions, two classes will be randomly assigned to HIIT (2 sessions/week) +nutrition group, and two to the nutrition group.
Similarly, in the school with one PE session per week, two classes will be randomly assigned to HIIT (1 session/week) + nutrition and two classes to the nutrition goup.
Both HIIT and nutritional education sessions will be integrated integrated into the physical education and sciences sessions of the schools.
The duration of the intervention will be of eight weeks.
School-based nutritional education on healthy dietary habits
|
|
Experimental: HIIT one session
One session per week of HIIT + nutritional education (1 session/week)
|
Two schools with four classes/groups of 4th degree of children will participate in the pilot study (i.e., age of children 9-10 years old).
One of them has two physical education (PE) sessions per week and the other has only one PE session per week.
In the school with two PE sessions, two classes will be randomly assigned to HIIT (2 sessions/week) +nutrition group, and two to the nutrition group.
Similarly, in the school with one PE session per week, two classes will be randomly assigned to HIIT (1 session/week) + nutrition and two classes to the nutrition goup.
Both HIIT and nutritional education sessions will be integrated integrated into the physical education and sciences sessions of the schools.
The duration of the intervention will be of eight weeks.
School-based nutritional education on healthy dietary habits
|
|
Comparador activo: Nutritional education
Nutritional education (1 session/week)
|
School-based nutritional education on healthy dietary habits
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in cardiorespiratory fitness
Periodo de tiempo: Change from baseline cardiorespiratory fitness at eight weeks
|
20m shuttle run test (Alpha battery)
|
Change from baseline cardiorespiratory fitness at eight weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Body fat
Periodo de tiempo: Change from baseline body fat at eight weeks
|
Body fat percent measured by bioimpedance
|
Change from baseline body fat at eight weeks
|
|
Change in Ankle-brachial index
Periodo de tiempo: Change from baseline Ankle-brachial index at eight weeks
|
Automated simultaneous blood pressure measurement
|
Change from baseline Ankle-brachial index at eight weeks
|
|
Change in Dietary habits
Periodo de tiempo: Change from baseline Dietary habits at eight weeks
|
Food frequency questionnaire and 24h recall
|
Change from baseline Dietary habits at eight weeks
|
|
Change in Muscular strength
Periodo de tiempo: Change from baseline Muscular strength at eight weeks
|
Handgrip strength and long jump (Alpha battery)
|
Change from baseline Muscular strength at eight weeks
|
|
Change in speed-agility
Periodo de tiempo: Change from baseline speed agility at eight weeks
|
4x10m speed agility test (Alpha battery)
|
Change from baseline speed agility at eight weeks
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PI-018/17
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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