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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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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Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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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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Kein Eingriff: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Bone speed of sound values
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Serum Cortisol levels
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Yağmur Sezer Efe, TC Erciyes University
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2016/282
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