- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01041820
Critical Periods of Exercise
Early childhood (~3-7 years of age) is an important window for determining body composition trajectory and may be a critical period for the development of tissue partitioning patterns that influence obesity risk. As adiposity accelerates during this critical period, deposition/ preservation of fat stores may be sustained at the 'expense' of other tissues; i.e. energy homeostasis may be inherently biased toward fat gain. The type and amount of tissue mass accrued in early childhood has implications for metabolic profile, glucose/insulin homeostasis, hormone profile and resting energy expenditure.
The interplay between fat and bone deposition represents a physiologic trait enabling the body to choose between shuttling 'energy' towards accrual of a particular tissue. Plausibly the phenotype underlying obesity and diabetes risk may be determined by the differentiation of cell type (adipocyte, osteocyte, etc.) during this early stage of growth and development. In vitro studies demonstrate transdifferentiation under the influence of specific external stimuli, which can switch phenotypes toward other cell lineages. Further, rodent models have demonstrated that exposure to stimuli (exercise) early in life may prevent excess fat mass accrual in adulthood, even when the stimulus is later removed (animals are no longer exercising). Children's early experiences (engagement in physical activity vs. sedentary behavior) may 'environmentally induce' alterations in body composition and predispose individuals to obesity throughout life.
Aim 1. To examine the associations between body composition via DXA and objectively-measured physical activity/inactivity.
- Hypothesis 1.1: There is a positive association between physical activity and bone mass.
Hypothesis 1.2: There is a positive association between sedentary behavior and total fat mass.
Aim2. To examine the associations between adipose tissue distribution via MRI and objectively-measured physical activity/inactivity.
- Hypothesis 2.1: There is an inverse association between physical activity and bone marrow adipose tissue.
- Hypothesis 2.2: There is a positive association between sedentary behavior and bone marrow adipose tissue.
Descripción general del estudio
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- University of Alabama at Birmingham
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Birmingham, Alabama, Estados Unidos, 35210
- Family Care Center
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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:
- children aged 3 to 7 years
- healthy, not under the care of a doctor
- not taking medications known to alter body composition or metabolism
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Exercise group
Children will participate in a 10-week moderate to vigorous exercise program
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Children will be exposed to a 10-week exercise intervention
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Sin intervención: non-exercising
Participants will receive no intervention
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Association between exercise and bone marrow adipose tissue in children 3-7 years
Periodo de tiempo: 10 weeks of exercise
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10 weeks of exercise
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
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
- ejercicio
- densidad mineral del hueso
- tejido adiposo de médula ósea
- Children in the intervention condition will complete a supervised physical activity program 3 days/wk for 10 weeks
- Control treatment will be provided no intervention
- All participants will be instructed not to change their current dietary habits during the study period.
Otros números de identificación del estudio
- F090904001
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