<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/NCT03774329</url>
  </required_header>
  <id_info>
    <org_study_id>2017_04</org_study_id>
    <secondary_id>2018-A00423-52</secondary_id>
    <nct_id>NCT03774329</nct_id>
  </id_info>
  <brief_title>Impact of a Physical Activity Program on Bone Mineral Density in Children and Adolescents With Chronic Inflammatory Bowel Disease</brief_title>
  <acronym>PROPHYSICOS</acronym>
  <official_title>Impact of a Physical Activity Program on Bone Mineral Density (BMD) in Children / Adolescents With Chronic Inflammatory Bowel Disease (IBD): Crohn's Disease, Ulcerative Colitis, Unclassified Chronic Colitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</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>
      Muscle and physical activity play an important role in in growth, development and bone health&#xD;
      in healthy children, especially during puberty. Children with inflammatory bowel disease&#xD;
      (IBD) have lower level and intensity of physical compared to a control group. Several studies&#xD;
      have shown that children with IBD have a lower bone mineral density (BMD) than general&#xD;
      population, due to risk factors such as corticosteroid use, disease intensity, inflammation,&#xD;
      malnutrition and a vitamin D deficiency. This low BMD is associated with an increased risk of&#xD;
      fracture. A recent observational study found a positive and significant correlation between&#xD;
      BMD in IBD patients and time spent in moderate to vigorous physical activity for one week&#xD;
      (unpublished data).The present study aims to show a benefit of an adapted physical activity&#xD;
      program on BMD in children and adolescents with IBD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 2, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">November 2023</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in total (whole body) Bone Mineral Density</measure>
    <time_frame>At 9 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in vertebral BMD</measure>
    <time_frame>At 9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in femoral body BMD</measure>
    <time_frame>At 9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in time spent (minutes / day) in moderate to vigorous physical activity measured by accelerometry for 7 days</measure>
    <time_frame>At 9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in in fat mass measured by two-photon absorptiometry (%)</measure>
    <time_frame>At 9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in lean mass measured by two-photon absorptiometry (kg)</measure>
    <time_frame>At 9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change IMPACT score III</measure>
    <time_frame>At 9 months</time_frame>
    <description>related quality of life instrument in children with inflammatory bowel disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pediatrics crohn's disease activity index or pediatric ulcerative colitis activity index</measure>
    <time_frame>At 9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in biologic inflammatory parameters by decrease or increase C-reactive protein</measure>
    <time_frame>At 9 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Crohn's Enteritis</condition>
  <condition>Crohn Disease</condition>
  <condition>Ulcerative Colitis</condition>
  <condition>Chronic; Colitis (Noninfective)</condition>
  <arm_group>
    <arm_group_label>physical activity program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Child with an adapted physical activity program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>Patients included in the control group will not benefit from the intervention in adapted physical activity. However, this will not affect their support. Patients will be seen by their specialist doctor as part of the usual management of their IBD.</description>
    <arm_group_label>Usual care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>adapted physical activity</intervention_name>
    <description>Patients in the experimental group will have, in addition to their usual follow-up with their specialist doctor, an intervention in adapted physical activity at home, at the rate of 3 sessions (of a duration of 10 to 20 minutes) per week during 9 consecutive months.</description>
    <arm_group_label>physical activity program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with IBD (Crohn's disease, ulcerative colitis or unclassified chronic colitis)&#xD;
             since at least 6 months.&#xD;
&#xD;
          -  Computer and internet access at home.&#xD;
&#xD;
          -  Consent to adhere to a physical activity program.&#xD;
&#xD;
          -  Assent of the child to participation in the research protocol.&#xD;
&#xD;
          -  Informed consent of parents or legal guardian.&#xD;
&#xD;
          -  Patient benefiting from national health.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  At time of inclusion, acute intercurrent events which may lead to a decrease in&#xD;
             physical activity (according to the judgment of the investigator) as fractures, recent&#xD;
             arthritis, ano-perineal lesions, severe dermatological lesions.&#xD;
&#xD;
          -  Chronic, acute or intermittent diseases (other than IBD) that may lead to a decrease&#xD;
             in physical activity.&#xD;
&#xD;
          -  Refusal of the child to participate to the protocol.&#xD;
&#xD;
          -  Refusal of one of the child's parents to participate in the protocol.&#xD;
&#xD;
          -  Predictable lack of compliance to study procedures (especially to the physical&#xD;
             activity program).&#xD;
&#xD;
          -  Child with visual impairment.&#xD;
&#xD;
          -  Participation in another interventional study.&#xD;
&#xD;
          -  Pregnant or lactating women.&#xD;
&#xD;
          -  Patient under protection of justice.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stéphanie COOPMAN, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Stéphanie COOPMAN, MD</last_name>
    <phone>0320445962</phone>
    <phone_ext>+33</phone_ext>
    <email>stephanie.coopman@chru-lille.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chu Amiens Picardie</name>
      <address>
        <city>Amiens</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hop Jeanne de Flandre Chu Lille</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>February 6, 2023</last_update_submitted>
  <last_update_submitted_qc>February 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>inflammatory bowel disease</keyword>
  <keyword>physical activity</keyword>
  <keyword>bone mineral density</keyword>
  <keyword>pediatric</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Colitis</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
    <mesh_term>Enteritis</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <!-- 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/NCT03774329
org study id: 2017_04
secondary id: 2018-A00423-52
nct id: NCT03774329
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Muscle and physical activity play an important role in in growth, development and bone health
      in healthy children, especially during puberty. Children with inflammatory bowel disease
      (IBD) have lower level and intensity of physical compared to a control group. Several studies
      have shown that children with IBD have a lower bone mineral density (BMD) than general
      population, due to risk factors such as corticosteroid use, disease intensity, inflammation,
      malnutrition and a vitamin D deficiency. This low BMD is associated with an increased risk of
      fracture. A recent observational study found a positive and significant correlation between
      BMD in IBD patients and time spent in moderate to vigorous physical activity for one week
      (unpublished data).The present study aims to show a benefit of an adapted physical activity
      program on BMD in children and adolescents with IBD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in total (whole body) Bone Mineral Density
time frame: At 9 months
measure: Change in vertebral BMD
time frame: At 9 months
measure: Change in femoral body BMD
time frame: At 9 months
measure: Change in time spent (minutes / day) in moderate to vigorous physical activity measured by accelerometry for 7 days
time frame: At 9 months
measure: Change in in fat mass measured by two-photon absorptiometry (%)
time frame: At 9 months
measure: Change in lean mass measured by two-photon absorptiometry (kg)
time frame: At 9 months
measure: Change IMPACT score III
time frame: At 9 months
description: related quality of life instrument in children with inflammatory bowel disease.
measure: Change in pediatrics crohn's disease activity index or pediatric ulcerative colitis activity index
time frame: At 9 months
measure: Change in biologic inflammatory parameters by decrease or increase C-reactive protein
time frame: At 9 months
arm group label: physical activity program
arm group type: Experimental
description: Child with an adapted physical activity program
arm group label: Usual care
arm group type: Other
intervention type: Other
intervention name: Usual care
description: Patients included in the control group will not benefit from the intervention in adapted physical activity. However, this will not affect their support. Patients will be seen by their specialist doctor as part of the usual management of their IBD.
arm group label: Usual care
intervention type: Other
intervention name: adapted physical activity
description: Patients in the experimental group will have, in addition to their usual follow-up with their specialist doctor, an intervention in adapted physical activity at home, at the rate of 3 sessions (of a duration of 10 to 20 minutes) per week during 9 consecutive months.
arm group label: physical activity program
criteria: 
gender: All
minimum age: 6 Years
maximum age: 18 Years
healthy volunteers: No
last name: Stéphanie COOPMAN, MD
role: Principal Investigator
affiliation: University Hospital, Lille
last name: Stéphanie COOPMAN, MD
phone: 0320445962
phone ext: +33
email: stephanie.coopman@chru-lille.fr
facility: 
status: Recruiting
facility: 
status: Recruiting
country: France
responsible party type: Sponsor
mesh term: Crohn Disease
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases
mesh term: Enteritis
mesh term: Ulcer