The Effect of Daily Exercise Program on Bone Mineral Density and Cortisol Level in Preterm Infants
The Effect of Daily Exercise Program on Bone Mineral Density and Cortisol Level in Preterm Infants With Very Low Birth Weight: A Randomized Controlled Trial
ABSTRACT Objective: This randomized controlled double-blinded experimental study was carried out to determine the effects of daily exercise program on bone mineral density and cortisol level in preterm infants with very low birth weight matched for birth weight, gestation week, and gender.
Study design: The study was performed with preterm infants hospitalized in the neonatal intensive care unit of a tertiary hospital. Ethical committee approval, institutional permission, parental written consent were obtained. Daily exercise program was implemented in preterm infants in the exercise group for 30 days, once a day, and continuing for 7-10 minutes. Before and after the study the following were evaluated in preterm infants in the exercise and control group: anthropometric measurements, tibia speed of sound (SOS) for bone mineral density, serum biochemical parameters and cortisol levels.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Objective: This randomized controlled double-blinded experimental study was carried out to determine the effects of daily exercise program on bone mineral density and cortisol level in preterm infants with very low birth weight matched for birth weight, gestation week, and gender.
Study design: The study was performed with preterm infants hospitalized in the neonatal intensive care unit of a tertiary hospital. Ethical committee approval, institutional permission, parental written consent were obtained. Daily exercise program was implemented in preterm infants in the exercise group for 30 days, once a day, and continuing for 7-10 minutes. Before and after the study the following were evaluated in preterm infants in the exercise and control group: anthropometric measurements, tibia speed of sound (SOS) for bone mineral density, serum biochemical parameters and cortisol levels.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:Inclusion criteria for the infants were as follows:
- postnatal age of 1-5 days,
- gestational age of 28-32 weeks,
- birth weight of 1,000-1,500 gr,
- no diagnosis of necrotizing enterocolitis (NEC), digestive system or chromosomal abnormalities, skin diseases, intrauterine growth retardation (IUGR), SGA, and large gestational age (LGA),
- no history of surgical intervention, and
- no medical treatment except for appropriate vitamin supplements and antibiotic treatments.
Exclusion Criteria:
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Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Exercise Group
Daily exercise program involved "Range of Motion (ROM) exercises against extremity resistances" and "extension and flexion in upper and lower extremities."
Exercises were implemented on wrists, elbows, shoulders, ankles, knees, and hip joints of the infants by the same researcher (YSE).
The daily exercise program was repeated 5-8 times, 1 session/day (a similar time of the day), for 30 days.
Each session continued for 7-10 minutes.
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Daily Exercise Programme
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Sin intervención: Control Group
The preterm infants in the control group did not receive the daily exercise program, only the standard clinical routine.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Bone speed of sound values
Periodo de tiempo: Change from bone speed of sound values at 30 days
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To measure SOS values, the preterm infant was placed on his/her back and his/her right leg was placed to obtain an angle of 900.
The middle of the medial malleolus and distal patella apex was found and then gel was poured between the skin and the probe.
The probe was put parallel to the bone to contact the point determined to be in the middle of the tibia and was moved from inside the leg.
Afterward, the probe was placed from outside the leg toward the inside.
In this study, The SOS from tibia was measured.
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Change from bone speed of sound values at 30 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Serum Cortisol levels
Periodo de tiempo: Change from serum cortisol levels at 30 days
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serum biochemical parameters
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Change from serum cortisol levels at 30 days
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Yağmur Sezer Efe, TC Erciyes University
Publicaciones y enlaces útiles
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
- 2016/282
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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