The Effect of Daily Exercise Program on Bone Mineral Density and Cortisol Level in Preterm Infants
NCT ID: NCT03773679
Last Updated: 2018-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2016-04-15
2017-08-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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.
Daily Exercise
Daily Exercise Programme
Control Group
The preterm infants in the control group did not receive the daily exercise program, only the standard clinical routine.
No interventions assigned to this group
Interventions
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Daily Exercise
Daily Exercise Programme
Eligibility Criteria
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Inclusion Criteria
* 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
28 Weeks
32 Weeks
ALL
No
Sponsors
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TC Erciyes University
OTHER
Responsible Party
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Yağmur Sezer Efe
Principal Investigator
Principal Investigators
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Yagmur Sezer Efe
Role: PRINCIPAL_INVESTIGATOR
TC Erciyes University
References
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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.
Other Identifiers
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2016/282
Identifier Type: -
Identifier Source: org_study_id