Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Daily Exercise Program on Bone Mineral Density and Cortisol Level in Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03773679
Recruitment Status : Completed
First Posted : December 12, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Yağmur Sezer Efe, TC Erciyes University

Tracking Information
First Submitted Date  ICMJE December 3, 2018
First Posted Date  ICMJE December 12, 2018
Last Update Posted Date December 12, 2018
Actual Study Start Date  ICMJE April 15, 2016
Actual Primary Completion Date April 15, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2018)
Bone speed of sound values [ Time Frame: Change from bone speed of sound values at 30 days ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2018)
Serum Cortisol levels [ Time Frame: Change from serum cortisol levels at 30 days ]
serum biochemical parameters
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Daily Exercise Program on Bone Mineral Density and Cortisol Level in Preterm Infants
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Osteopenia of Prematurity
Intervention  ICMJE Procedure: Daily Exercise
Daily Exercise Programme
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Daily Exercise
  • No Intervention: Control Group
    The preterm infants in the control group did not receive the daily exercise program, only the standard clinical routine.
Publications * Sezer Efe Y, Erdem E, Güneş 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 10, 2018)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 31, 2017
Actual Primary Completion Date April 15, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 28 Weeks to 32 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03773679
Other Study ID Numbers  ICMJE 2016/282
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yağmur Sezer Efe, TC Erciyes University
Study Sponsor  ICMJE TC Erciyes University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yagmur Sezer Efe TC Erciyes University
PRS Account TC Erciyes University
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP