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

Primary Purpose

Osteopenia of Prematurity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Daily Exercise
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteopenia of Prematurity focused on measuring Preterm infants with very low birth weight (VLBW), bone mineral density, cortisol, exercise

Eligibility Criteria

28 Weeks - 32 Weeks (Child)All SexesDoes not accept healthy volunteers

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:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Exercise Group

    Control Group

    Arm Description

    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.

    The preterm infants in the control group did not receive the daily exercise program, only the standard clinical routine.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Serum Cortisol levels
    serum biochemical parameters

    Full Information

    First Posted
    December 3, 2018
    Last Updated
    December 10, 2018
    Sponsor
    TC Erciyes University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03773679
    Brief Title
    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

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 15, 2016 (Actual)
    Primary Completion Date
    April 15, 2016 (Actual)
    Study Completion Date
    August 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    TC Erciyes University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteopenia of Prematurity
    Keywords
    Preterm infants with very low birth weight (VLBW), bone mineral density, cortisol, exercise

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Exercise Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    The preterm infants in the control group did not receive the daily exercise program, only the standard clinical routine.
    Intervention Type
    Procedure
    Intervention Name(s)
    Daily Exercise
    Intervention Description
    Daily Exercise Programme
    Primary Outcome Measure Information:
    Title
    Bone speed of sound values
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Serum Cortisol levels
    Description
    serum biochemical parameters
    Time Frame
    Change from serum cortisol levels at 30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    28 Weeks
    Maximum Age & Unit of Time
    32 Weeks
    Accepts Healthy Volunteers
    No
    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: -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yagmur Sezer Efe
    Organizational Affiliation
    TC Erciyes University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    31285069
    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.
    Results Reference
    derived

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

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