Clinical trial NCT03773679: The Effect of Daily Exercise Program on Bone Mineral Density and Cortisol Level in Preterm Infants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteopenia of Prematurity
Keywords: Preterm infants with very low birth weight (VLBW)
bone mineral density
cortisol
exercise
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2018-12-12
Enrollment: 24
Sex: ALL
Minimum age (years): 28
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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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Primary outcomes:
measure: Bone speed of sound values
timeFrame: Change from bone speed of sound values at 30 days
Secondary outcomes:
measure: Serum Cortisol levels
timeFrame: Change from serum cortisol levels at 30 days
Other outcomes:
Locations:
Study officials:
affiliation: TC Erciyes University
name: Yagmur Sezer Efe
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sezer Efe Y, Erdem E, Gunes T. 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. J Pediatr Nurs. 2020 Mar-Apr;51:e6-e12. doi: 10.1016/j.pedn.2019.05.021. Epub 2019 Jul 6.