<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/NCT03245164</url>
  </required_header>
  <id_info>
    <org_study_id>EasternMUZ</org_study_id>
    <nct_id>NCT03245164</nct_id>
  </id_info>
  <brief_title>The Effects of Group Exercise and Basketball on Obese Children</brief_title>
  <official_title>Comparing the Effects of Group Exercise and Basketball on Body Composition and Motor Skills of Obese Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eastern Mediterranean University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Eastern Mediterranean 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>
      This study aimed to compare the effects of group exercises under physiotherapist control and&#xD;
      basketball program on body composition and motor skills of obese children. 45 obese children&#xD;
      aged 10 years were randomly included to the physiotherapy (n=15), basketball (n:15), and&#xD;
      control group (n:15). The children were assessed before and after 12-week study duration.&#xD;
      Body Mass Index (BMI), the percentage of body fat, and circumference values of the children&#xD;
      were recorded. Bruininks-Oseretsky Test of Motor Proficiency-Brief Form (BOTMP-BF) was used&#xD;
      to determine motor skills of children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The roles of active physiotherapy programs and sport programs on the management of the&#xD;
      problems arising from childhood obesity should be determined. Although the effects of&#xD;
      exercise and various sport branches on decrease obesity and obesity related problems, the&#xD;
      effects of group exercises managed by physiotherapists and team sports on body composition&#xD;
      and motor skills of obese children are not clear so health professionals may have&#xD;
      difficulties while suggesting better physical activity for this population.&#xD;
&#xD;
      Thus, body composition and motor skills of the included children were recorded at the&#xD;
      beginning. They were then grouped into three in order to compare the effects of group&#xD;
      exercises and basketball. Children in the control group did not participate in any of them.&#xD;
      Intervention lasted 12 weeks so they were then taken to the assessments at the end of this&#xD;
      duration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2015</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bruininks-Oseretsky Test of Motor Proficiency-Brief Form (BOTMP-BF)</measure>
    <time_frame>12 weeks</time_frame>
    <description>The BOTMP-BF test was used to determine the motor skills of the children. It is a popularly used test to specify the level of motor skills of children. Touching nose with index fingers as eyes closed and pivoting thumbs and index fingers were scored for bilateral coordination. Walking forward heel-to-toe on a line for balance, push-up numbers for strength,and number of one-legged side hop in a given duration for speed-agility were scored. Filling in a star, drawing a line through a path, and copying shapes were scored to determine fine motor integration. Stringing blocks in a given time duration was scored for manual dexterity. Catching a Tossed-ball with one hand and dribbling a ball with alternative hands were scored for upper limb coordination. Scoring is explained in the booklet of BOTMP-BF. A total score of this test was acquired.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index</measure>
    <time_frame>12 weeks</time_frame>
    <description>Body Mass Index (BMI) was calculated as weight (in kilograms) divided by height (in meters) squared (kg/m2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Fat</measure>
    <time_frame>12 weeks</time_frame>
    <description>Body fat was determined by skinfold measurements (in milimeters). Lange Skinfold caliper (Cambridge Scientific Industries, Cambridge, MD) was used to determine the percentage of body fat. Triceps, biceps, chest, sucscapula, abdominal, and suprailiac regions were measured. All measurements were taken only from the right side of their body. During these measurements, all children remained standing. Slaughter's equation was used to calculate the percentage of body fat.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circumferences</measure>
    <time_frame>12 weeks</time_frame>
    <description>Arm, waist, chest, and hip circumferences were measured using an inelastic tape while the children were standing and breathing normally. Right arm was taken as a reference for circumference. Values were recorded in centimeters.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Childhood Obesity</condition>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>Physiotherapy group exercises</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group continued physiotherapy group exercises for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Basketball program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Basketball educaiton was presented for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group did not continue any physical activity regularly.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physiotherapy group exercises</intervention_name>
    <description>Physiotherapy exercises had aerobic, balance, strength exercises with music.</description>
    <arm_group_label>Physiotherapy group exercises</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Basketball program</intervention_name>
    <description>Basketball education presented the techniques about playing basketball and basketball games were played.</description>
    <arm_group_label>Basketball program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children who were born in 2006 (10 years old),&#xD;
&#xD;
          -  children whose BMI values were ≥95. Percentiles,&#xD;
&#xD;
          -  a report which was given by a doctor to state that the child could participate in&#xD;
             aerobic exercise,&#xD;
&#xD;
          -  children who had not continued to a diet program for 3 months,&#xD;
&#xD;
          -  children who had not participated regularly in any sport or exercise for 6 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  children who had any disease requiring use of medicine,&#xD;
&#xD;
          -  children who had any pain to prevent doing exercise or sport,&#xD;
&#xD;
          -  children who had any neuromuscular disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>OZLEM ÜLGER, Assist.Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <reference>
    <citation>Alberga AS, Prud'homme D, Sigal RJ, Goldfield GS, Hadjiyannakis S, Phillips P, Malcolm J, Ma J, Doucette S, Gougeon R, Wells GA, Kenny GP. Effects of aerobic training, resistance training, or both on cardiorespiratory and musculoskeletal fitness in adolescents with obesity: the HEARTY trial. Appl Physiol Nutr Metab. 2016 Mar;41(3):255-65. doi: 10.1139/apnm-2015-0413. Epub 2015 Nov 9.</citation>
    <PMID>26881317</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>August 7, 2017</last_update_submitted>
  <last_update_submitted_qc>August 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>obese children</keyword>
  <keyword>motor skills</keyword>
  <keyword>physiotherapy</keyword>
  <keyword>basketball</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pediatric Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Body Mass Indexes of children who continued 4th class in all primary schools in the study city were recorded. The parents of children who had 95.&gt; percentiles of BMI values were then invited to the study and the participants who accepted the invitation were assessed. They were then evaluated and randomly assigned to three groups. The number for each group was determined by power analysis.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>2 months</ipd_time_frame>
    <ipd_access_criteria>Primary schools of the city where the study would take place in were analysed for the appropriate body mass indexes. The parents were then invited to participate in the study.</ipd_access_criteria>
  </patient_data>
  <pending_results>
    <submitted>August 14, 2017</submitted>
    <returned>February 15, 2018</returned>
  </pending_results>
  <!-- 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/NCT03245164
org study id: EasternMUZ
nct id: NCT03245164
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study aimed to compare the effects of group exercises under physiotherapist control and
      basketball program on body composition and motor skills of obese children. 45 obese children
      aged 10 years were randomly included to the physiotherapy (n=15), basketball (n:15), and
      control group (n:15). The children were assessed before and after 12-week study duration.
      Body Mass Index (BMI), the percentage of body fat, and circumference values of the children
      were recorded. Bruininks-Oseretsky Test of Motor Proficiency-Brief Form (BOTMP-BF) was used
      to determine motor skills of children.
The roles of active physiotherapy programs and sport programs on the management of the
      problems arising from childhood obesity should be determined. Although the effects of
      exercise and various sport branches on decrease obesity and obesity related problems, the
      effects of group exercises managed by physiotherapists and team sports on body composition
      and motor skills of obese children are not clear so health professionals may have
      difficulties while suggesting better physical activity for this population.

      Thus, body composition and motor skills of the included children were recorded at the
      beginning. They were then grouped into three in order to compare the effects of group
      exercises and basketball. Children in the control group did not participate in any of them.
      Intervention lasted 12 weeks so they were then taken to the assessments at the end of this
      duration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Bruininks-Oseretsky Test of Motor Proficiency-Brief Form (BOTMP-BF)
time frame: 12 weeks
description: The BOTMP-BF test was used to determine the motor skills of the children. It is a popularly used test to specify the level of motor skills of children. Touching nose with index fingers as eyes closed and pivoting thumbs and index fingers were scored for bilateral coordination. Walking forward heel-to-toe on a line for balance, push-up numbers for strength,and number of one-legged side hop in a given duration for speed-agility were scored. Filling in a star, drawing a line through a path, and copying shapes were scored to determine fine motor integration. Stringing blocks in a given time duration was scored for manual dexterity. Catching a Tossed-ball with one hand and dribbling a ball with alternative hands were scored for upper limb coordination. Scoring is explained in the booklet of BOTMP-BF. A total score of this test was acquired.
measure: Body Mass Index
time frame: 12 weeks
description: Body Mass Index (BMI) was calculated as weight (in kilograms) divided by height (in meters) squared (kg/m2).
measure: Body Fat
time frame: 12 weeks
description: Body fat was determined by skinfold measurements (in milimeters). Lange Skinfold caliper (Cambridge Scientific Industries, Cambridge, MD) was used to determine the percentage of body fat. Triceps, biceps, chest, sucscapula, abdominal, and suprailiac regions were measured. All measurements were taken only from the right side of their body. During these measurements, all children remained standing. Slaughter's equation was used to calculate the percentage of body fat.
measure: Circumferences
time frame: 12 weeks
description: Arm, waist, chest, and hip circumferences were measured using an inelastic tape while the children were standing and breathing normally. Right arm was taken as a reference for circumference. Values were recorded in centimeters.
arm group label: Physiotherapy group exercises
arm group type: Experimental
description: This group continued physiotherapy group exercises for 12 weeks.
arm group label: Basketball program
arm group type: Experimental
description: Basketball educaiton was presented for 12 weeks.
arm group label: Control group
arm group type: No Intervention
description: This group did not continue any physical activity regularly.
intervention type: Other
intervention name: Physiotherapy group exercises
description: Physiotherapy exercises had aerobic, balance, strength exercises with music.
arm group label: Physiotherapy group exercises
intervention type: Other
intervention name: Basketball program
description: Basketball education presented the techniques about playing basketball and basketball games were played.
arm group label: Basketball program
criteria: 
gender: All
minimum age: 10 Years
maximum age: 10 Years
healthy volunteers: No
last name: OZLEM ÜLGER, Assist.Prof.
role: Study Director
affiliation: Hacettepe University
citation: Alberga AS, Prud'homme D, Sigal RJ, Goldfield GS, Hadjiyannakis S, Phillips P, Malcolm J, Ma J, Doucette S, Gougeon R, Wells GA, Kenny GP. Effects of aerobic training, resistance training, or both on cardiorespiratory and musculoskeletal fitness in adolescents with obesity: the HEARTY trial. Appl Physiol Nutr Metab. 2016 Mar;41(3):255-65. doi: 10.1139/apnm-2015-0413. Epub 2015 Nov 9.
PMID: 26881317
responsible party type: Sponsor
mesh term: Pediatric Obesity
sharing ipd: Yes
ipd description: Body Mass Indexes of children who continued 4th class in all primary schools in the study city were recorded. The parents of children who had 95.> percentiles of BMI values were then invited to the study and the participants who accepted the invitation were assessed. They were then evaluated and randomly assigned to three groups. The number for each group was determined by power analysis.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: 2 months
ipd access criteria: Primary schools of the city where the study would take place in were analysed for the appropriate body mass indexes. The parents were then invited to participate in the study.
submitted: August 14, 2017
returned: February 15, 2018