An interventional study of Daily Exercise in Osteopenia of Prematurity, sponsored by TC Erciyes University. Completed. Open to participants aged 28 Weeks to 32 Weeks. Per ClinicalTrials.gov, last updated 2018-12-12.
Sponsored by TC Erciyes University · Not applicable, Interventional, and Prevention
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.
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.
487 studies on the registry are indexed under Bone Diseases, Metabolic; 74 are open to participants now.
This study's enrollment of 24 is below the median of 61 across 372 interventional studies indexed under Bone Diseases, Metabolic.
Browse Bone Diseases, Metabolic studies →TC Erciyes University is the lead sponsor of 346 studies on the registry; 76 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:Inclusion criteria for the infants were as follows:
Exclusion Criteria:
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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.
Procedure: Daily Exercise
The preterm infants in the control group did not receive the daily exercise program, only the standard clinical routine.
Daily Exercise Programme
Bone speed of sound values
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.
Time frame: Change from bone speed of sound values at 30 days
Serum Cortisol levels
serum biochemical parameters
Time frame: Change from serum cortisol levels at 30 days
No study locations are listed for this record.
Plan to share: No
Ran from Apr 2016 to primary completion in Apr 2016, 0 months.
Of 114 non-industry interventional studies with no phase under Bone Diseases, Metabolic, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 35. This study's 0 months is below that.
Counting every sponsor, half of 129 studies reached it within 21 months; a quarter within 10 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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