<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03773679</url>
  </required_header>
  <id_info>
    <org_study_id>2016/282</org_study_id>
    <nct_id>NCT03773679</nct_id>
  </id_info>
  <brief_title>The Effect of Daily Exercise Program on Bone Mineral Density and Cortisol Level in Preterm Infants</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TC Erciyes University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>TC Erciyes University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      ABSTRACT Objective: This randomized controlled double-blinded experimental study was carried&#xD;
      out to determine the effects of daily exercise program on bone mineral density and cortisol&#xD;
      level in preterm infants with very low birth weight matched for birth weight, gestation week,&#xD;
      and gender.&#xD;
&#xD;
      Study design: The study was performed with preterm infants hospitalized in the neonatal&#xD;
      intensive care unit of a tertiary hospital. Ethical committee approval, institutional&#xD;
      permission, parental written consent were obtained. Daily exercise program was implemented in&#xD;
      preterm infants in the exercise group for 30 days, once a day, and continuing for 7-10&#xD;
      minutes. Before and after the study the following were evaluated in preterm infants in the&#xD;
      exercise and control group: anthropometric measurements, tibia speed of sound (SOS) for bone&#xD;
      mineral density, serum biochemical parameters and cortisol levels.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: This randomized controlled double-blinded experimental study was carried out to&#xD;
      determine the effects of daily exercise program on bone mineral density and cortisol level in&#xD;
      preterm infants with very low birth weight matched for birth weight, gestation week, and&#xD;
      gender.&#xD;
&#xD;
      Study design: The study was performed with preterm infants hospitalized in the neonatal&#xD;
      intensive care unit of a tertiary hospital. Ethical committee approval, institutional&#xD;
      permission, parental written consent were obtained. Daily exercise program was implemented in&#xD;
      preterm infants in the exercise group for 30 days, once a day, and continuing for 7-10&#xD;
      minutes. Before and after the study the following were evaluated in preterm infants in the&#xD;
      exercise and control group: anthropometric measurements, tibia speed of sound (SOS) for bone&#xD;
      mineral density, serum biochemical parameters and cortisol levels.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2016</start_date>
  <completion_date type="Actual">August 31, 2017</completion_date>
  <primary_completion_date type="Actual">April 15, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bone speed of sound values</measure>
    <time_frame>Change from bone speed of sound values at 30 days</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum Cortisol levels</measure>
    <time_frame>Change from serum cortisol levels at 30 days</time_frame>
    <description>serum biochemical parameters</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Osteopenia of Prematurity</condition>
  <arm_group>
    <arm_group_label>Exercise Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Daily exercise program involved &quot;Range of Motion (ROM) exercises against extremity resistances&quot; and &quot;extension and flexion in upper and lower extremities.&quot; 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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The preterm infants in the control group did not receive the daily exercise program, only the standard clinical routine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Daily Exercise</intervention_name>
    <description>Daily Exercise Programme</description>
    <arm_group_label>Exercise Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:Inclusion criteria for the infants were as follows:&#xD;
&#xD;
          -  postnatal age of 1-5 days,&#xD;
&#xD;
          -  gestational age of 28-32 weeks,&#xD;
&#xD;
          -  birth weight of 1,000-1,500 gr,&#xD;
&#xD;
          -  no diagnosis of necrotizing enterocolitis (NEC), digestive system or chromosomal&#xD;
             abnormalities, skin diseases, intrauterine growth retardation (IUGR), SGA, and large&#xD;
             gestational age (LGA),&#xD;
&#xD;
          -  no history of surgical intervention, and&#xD;
&#xD;
          -  no medical treatment except for appropriate vitamin supplements and antibiotic&#xD;
             treatments.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>28 Weeks</minimum_age>
    <maximum_age>32 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yagmur Sezer Efe</last_name>
    <role>Principal Investigator</role>
    <affiliation>TC Erciyes University</affiliation>
  </overall_official>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>December 10, 2018</last_update_submitted>
  <last_update_submitted_qc>December 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>TC Erciyes University</investigator_affiliation>
    <investigator_full_name>Yağmur Sezer Efe</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Preterm infants with very low birth weight (VLBW)</keyword>
  <keyword>bone mineral density</keyword>
  <keyword>cortisol</keyword>
  <keyword>exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bone Diseases, Metabolic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03773679
org study id: 2016/282
nct id: NCT03773679
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Bone speed of sound values
time frame: Change from bone speed of sound values at 30 days
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.
measure: Serum Cortisol levels
time frame: Change from serum cortisol levels at 30 days
description: serum biochemical parameters
arm group label: Exercise Group
arm group type: Experimental
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 group label: Control Group
arm group type: No Intervention
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: Daily Exercise
description: Daily Exercise Programme
arm group label: Exercise Group
criteria: 
gender: All
minimum age: 28 Weeks
maximum age: 32 Weeks
healthy volunteers: No
last name: Yagmur Sezer Efe
role: Principal Investigator
affiliation: TC Erciyes University
responsible party type: Principal Investigator
investigator affiliation: TC Erciyes University
investigator full name: Yağmur Sezer Efe
investigator title: Principal Investigator
mesh term: Bone Diseases, Metabolic
sharing ipd: No