<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/NCT03783338</url>
  </required_header>
  <id_info>
    <org_study_id>P.T.REC/012/002143</org_study_id>
    <nct_id>NCT03783338</nct_id>
  </id_info>
  <brief_title>Interaction Effects of Vitamin D Supplementation and Aerobic Exercises on Balance and Physical Performance in Children With Down Syndrome</brief_title>
  <official_title>Interaction Effects of Vitamin D Supplementation and Aerobic Exercises on Balance and Physical Performance in Children With Down Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective: To investigate the interaction effects of vitamin D supplementation and aerobic&#xD;
      exercises on balance control and physical performance in children with Down syndrome (DS).&#xD;
&#xD;
      Methods: Forty-five children with DS ranging in age from 8 to 12 years will be selected and&#xD;
      will participate in this study. They will be assigned randomly using sealed envelopes into&#xD;
      three equal groups (A, B and C). Group A will consist of 15 children and will receive the&#xD;
      conventional physical therapy program (CPTP) only. Group B will consist of 15 children and&#xD;
      will receive the CPTP plus the aerobic exercises. Group C also will consist of 15 children&#xD;
      and will receive the CPTP, the aerobic exercises and Vitamin D supplementation in the form of&#xD;
      an oral dose of vitamin D3 1000 IU (Cholecalciferol). The program of treatment will be 3&#xD;
      days/week for 12 weeks. Evaluation of balance by using the biodex balance system and physical&#xD;
      performance by using the six-minute walk test (6MWT) will be conducted at baseline and after&#xD;
      12 weeks of the treatment program.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2, 2018</start_date>
  <completion_date type="Actual">March 2, 2019</completion_date>
  <primary_completion_date type="Actual">March 2, 2019</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>
    <intervention_model_description>Children will be assigned randomly using sealed envelopes into three intervention groups (A, B and C groups). Group A will receive the conventional physical therapy program (CPTP) only. Group B will receive the CPTP in addition to aerobic exercises, whereas group C will receive CPTP, aerobic exercises in addition to an oral daily dose of vitamin D3 1000 IU (Cholecalciferol). All groups will receive the treatment program for 12 weeks.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The outcomes assessor will be blinded to which each child allocated to any one of the three arms.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Balance</measure>
    <time_frame>This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.</time_frame>
    <description>Balance assessment will be conducted by using the Biodex Stability System (BSS; Biodex, Inc, Shirley, NY) that enables objective assessment of balance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical performance</measure>
    <time_frame>This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.</time_frame>
    <description>Physical performance will be evaluated using the six-minute walk test (6MWT).</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Children With Down Syndrome</condition>
  <arm_group>
    <arm_group_label>Physical therapy group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group A will consist of 15 children and will receive the conventional physical therapy program only. This group will be used to compare the results of the other two groups.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physical therapy and aerobic exercises group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group B will consist of 15 children and will receive the conventional physical therapy program and aerobic exercises.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physical therapy, aerobic exercises and vitamin D group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group C will consist of 15 children and will receive the conventional physical therapy program, aerobic exercises and an oral daily dose of vitamin D3 1000 IU (Cholecalciferol) .</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Aerobic exercises and Vitamin D supplementation</intervention_name>
    <description>Aerobic exercises:&#xD;
Children in groups B and C will receive aerobic exercises in the form of bicycle ergometer and treadmill training for 15 min 3 days/week for 12 weeks. The procedure and goals of exercise will be explained to all children before starting the exercise program. The child will stop exercising immediately if he feels pain, fainting or shortness of breath.&#xD;
Vitamin D supplementation:&#xD;
Children in group C only will receive vitamin D supplementation in the form of an oral daily dose of vitamin D3 1000 IU (Cholecalciferol) for 12 weeks.</description>
    <arm_group_label>Physical therapy and aerobic exercises group</arm_group_label>
    <arm_group_label>Physical therapy group</arm_group_label>
    <arm_group_label>Physical therapy, aerobic exercises and vitamin D group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children with DS who can stand and walk independently&#xD;
&#xD;
          -  Children with 25 (OH) vitamin D levels of 16 ng/ml or less&#xD;
&#xD;
          -  Children who are not consuming estrogens, steroids or other medications that could&#xD;
             interfere with vitamin D metabolism&#xD;
&#xD;
          -  The absence of visual and hearing impairments that could interfere with testing and&#xD;
             training protocols&#xD;
&#xD;
          -  Children with mild intellectual disabilities and were capable of understanding visual&#xD;
             and verbal instructions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical conditions that will severely limit a child's participation in the study as&#xD;
             cardiac problems.&#xD;
&#xD;
          -  Musculoskeletal deformities of the lower limbs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of Physical Therapy - Cairo University</name>
      <address>
        <city>Cairo</city>
        <state>Giza</state>
        <zip>12613</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>November 28, 2019</last_update_submitted>
  <last_update_submitted_qc>November 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Mohamed Ahmed Mahmoud Eid</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Aerobic exercises</keyword>
  <keyword>Balance</keyword>
  <keyword>Down syndrome</keyword>
  <keyword>Physical performance</keyword>
  <keyword>Vitamin D</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Down Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03783338
org study id: P.T.REC/012/002143
nct id: NCT03783338
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Objective: To investigate the interaction effects of vitamin D supplementation and aerobic
      exercises on balance control and physical performance in children with Down syndrome (DS).

      Methods: Forty-five children with DS ranging in age from 8 to 12 years will be selected and
      will participate in this study. They will be assigned randomly using sealed envelopes into
      three equal groups (A, B and C). Group A will consist of 15 children and will receive the
      conventional physical therapy program (CPTP) only. Group B will consist of 15 children and
      will receive the CPTP plus the aerobic exercises. Group C also will consist of 15 children
      and will receive the CPTP, the aerobic exercises and Vitamin D supplementation in the form of
      an oral dose of vitamin D3 1000 IU (Cholecalciferol). The program of treatment will be 3
      days/week for 12 weeks. Evaluation of balance by using the biodex balance system and physical
      performance by using the six-minute walk test (6MWT) will be conducted at baseline and after
      12 weeks of the treatment program.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Children will be assigned randomly using sealed envelopes into three intervention groups (A, B and C groups). Group A will receive the conventional physical therapy program (CPTP) only. Group B will receive the CPTP in addition to aerobic exercises, whereas group C will receive CPTP, aerobic exercises in addition to an oral daily dose of vitamin D3 1000 IU (Cholecalciferol). All groups will receive the treatment program for 12 weeks.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The outcomes assessor will be blinded to which each child allocated to any one of the three arms.
measure: Balance
time frame: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
description: Balance assessment will be conducted by using the Biodex Stability System (BSS; Biodex, Inc, Shirley, NY) that enables objective assessment of balance.
measure: Physical performance
time frame: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
description: Physical performance will be evaluated using the six-minute walk test (6MWT).
arm group label: Physical therapy group
arm group type: Active Comparator
description: Group A will consist of 15 children and will receive the conventional physical therapy program only. This group will be used to compare the results of the other two groups.
arm group label: Physical therapy and aerobic exercises group
arm group type: Experimental
description: Group B will consist of 15 children and will receive the conventional physical therapy program and aerobic exercises.
arm group label: Physical therapy, aerobic exercises and vitamin D group
arm group type: Experimental
description: Group C will consist of 15 children and will receive the conventional physical therapy program, aerobic exercises and an oral daily dose of vitamin D3 1000 IU (Cholecalciferol) .
intervention type: Combination Product
intervention name: Aerobic exercises and Vitamin D supplementation
description: Aerobic exercises:
Children in groups B and C will receive aerobic exercises in the form of bicycle ergometer and treadmill training for 15 min 3 days/week for 12 weeks. The procedure and goals of exercise will be explained to all children before starting the exercise program. The child will stop exercising immediately if he feels pain, fainting or shortness of breath.
Vitamin D supplementation:
Children in group C only will receive vitamin D supplementation in the form of an oral daily dose of vitamin D3 1000 IU (Cholecalciferol) for 12 weeks.
arm group label: Physical therapy and aerobic exercises group
arm group label: Physical therapy group
arm group label: Physical therapy, aerobic exercises and vitamin D group
criteria: 
gender: All
minimum age: 8 Years
maximum age: 12 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Mohamed Ahmed Mahmoud Eid
investigator title: Assistant Professor
mesh term: Down Syndrome
mesh term: Syndrome
mesh term: Vitamin D
sharing ipd: Undecided