<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/NCT02264275</url>
  </required_header>
  <id_info>
    <org_study_id>DSBG-UniBasel-Ex-CED-2014-220</org_study_id>
    <nct_id>NCT02264275</nct_id>
  </id_info>
  <brief_title>Influence of Aerobic Exercise Training (AET) on Inflammatory Bowel Disease (IBD) in Children and Adolescents</brief_title>
  <acronym>Ex-CED</acronym>
  <official_title>The Influence of Aerobic Exercise Training on Disease Symptoms, Cardiovascular Fitness, Depression, Sleep and Quality of Life in Children and Adolescents Suffering From Inflammatory Bowel Disease in Switzerland</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Basel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Children's Hospital Basel</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Psychiatric Hospital of the University of Basel</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Basel</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if aerobic exercise training can serve as&#xD;
      comprehensive palliative care, whereby enhancing cardiovascular fitness, mitigating&#xD;
      depressive symptoms and augmenting sleep while bolstering health related quality of life in&#xD;
      youth with Crohn's Disease and Ulcerative Colitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An AET intervention is designed to increase the aerobic fitness levels of IBD sufferers&#xD;
      through daily activity, which is notably lower in this population and could be beneficial for&#xD;
      sufferers managing this lifelong disease. With an increase in physical activity, the exergame&#xD;
      aims to introduce, instill and integrate daily physical activity in the lives of IBD&#xD;
      sufferers. The Just Dance Kids exergame for Nintendo Wii employs moderate intensity physical&#xD;
      activity and is well suited for this study. The exergame intervention protocol will comprise&#xD;
      a ramped duration aerobic exercise training starting with 10 minutes in week 1 and rises to&#xD;
      30 minutes per session in weeks 5 through 8. Just Dance Kids will be used by participants&#xD;
      under the age of 11 and Just Dance for participants over the age of 10 due to the age&#xD;
      appropriate dancing skill required in each game. The aim is to determine if this moderate&#xD;
      intensity, 5 times per week exercise could decrease IBD flare-ups, improve cardiovascular&#xD;
      fitness, reduce depressive symptoms, improve quality and quantity of sleep and improve the&#xD;
      health-related quality of life in children and adolescents with IBD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">March 2015</completion_date>
  <primary_completion_date type="Anticipated">February 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pediatric Disease Activity Index</measure>
    <time_frame>8 Weeks</time_frame>
    <description>Uses either Crohn's Disease or Ulcerative Colitis Disease Activity Index respective to the patient's disease</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sleep</measure>
    <time_frame>8 Weeks</time_frame>
    <description>Uses Insomnia Severity Index and Daily Sleep Log</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive Symptomology</measure>
    <time_frame>8 Weeks</time_frame>
    <description>Uses Child-S or Des-Teen with respect to participants age</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Related Quality of Life</measure>
    <time_frame>8 Weeks</time_frame>
    <description>KIDSCREEN-27</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimation of Vo2Max</measure>
    <time_frame>8 Weeks</time_frame>
    <description>Uses the Astrand-Rhyming cycle ergometer protocol</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Ulcerative Colitis</condition>
  <condition>Crohn Disease</condition>
  <condition>Depression</condition>
  <condition>Sleep</condition>
  <condition>Quality of Life</condition>
  <condition>Motor Activity</condition>
  <arm_group>
    <arm_group_label>Aerobic Exercise Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An 8-week Nintendo Wii at-home dancing exergame Intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Aerobic Exercise Training</intervention_name>
    <description>The aerobic exercise training uses a television attached to a Nintendo Wii videogame console with a dance game to be played by participants on 5 days per week using a ramped-duration schedule (from 10-30 minutes of moderate physical activity daily).</description>
    <arm_group_label>Aerobic Exercise Training</arm_group_label>
    <other_name>Nintendo Wii</other_name>
    <other_name>Exergame</other_name>
    <other_name>Dance Videogame</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged 7 through 20 at start of study&#xD;
&#xD;
          -  willing and able to volunteer in the study&#xD;
&#xD;
          -  able to communicate and to complete questionnaires in German&#xD;
&#xD;
          -  have a functioning television with Nintendo Wii compatibility at home&#xD;
&#xD;
          -  provide participant written informed consent (when ≥11 years old at start of study)&#xD;
&#xD;
          -  provide parental/legal caregiver written informed consent (when participant is ≤17&#xD;
             years old at start of study)&#xD;
&#xD;
          -  provide oral informed consent (when ≤10 years old at start of study)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refusal to give necessary oral or written informed consent by patient and/or parent&#xD;
             (legal caregiver)&#xD;
&#xD;
          -  not aged 7 through 20 at start of study&#xD;
&#xD;
          -  not willing and able to volunteer in the study&#xD;
&#xD;
          -  has sibling enrolled in this study&#xD;
&#xD;
          -  has severe physical diseases of the locomotor apparatus, psychotic disorders, severe&#xD;
             affective disorders, eating disorders, mental retardation, autism spectrum disorder&#xD;
&#xD;
          -  inability to communicate and complete questionnaires in German&#xD;
&#xD;
          -  does not own a functional and Nintendo Wii-compatible television at home&#xD;
&#xD;
          -  among female adolescents, pregnancy, breastfeeding or intention to get pregnant during&#xD;
             the study&#xD;
&#xD;
          -  has clinically significant cardiovascular disease&#xD;
&#xD;
          -  enrolment of the investigator, his/her family members, employees and other dependent&#xD;
             persons&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>20 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Catherine A Elliot, Dr. phil.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Basel</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Catherine A Elliot, Dr. phil.</last_name>
    <phone>0041 (0)61 377 87 80</phone>
    <email>catherine.elliot@unibas.ch</email>
  </overall_contact>
  <location>
    <facility>
      <name>Universitäre Psychiatrische Kliniken Basel (UPK)</name>
      <address>
        <city>Basel</city>
        <state>Basel Stadt</state>
        <zip>4012</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Serge Brand, PD Dr. med.</last_name>
      <phone>061 325 51 14</phone>
      <email>serge.brand@upkbs.ch</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitäts-Kinderspital beider Basel (UKBB)</name>
      <address>
        <city>Basel</city>
        <state>Basel Stadt</state>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Raoul Furlano, Dr. med.</last_name>
      <phone>+ 41 (0)61 704 2905</phone>
      <email>raoul.furlano@ukbb.ch</email>
    </contact>
    <investigator>
      <last_name>Raoul Furlano, Dr. med.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Universität Basel (Departement für Sport, Bewegung und Gesundheit)</name>
      <address>
        <city>Basel</city>
        <state>Basel Stadt</state>
        <zip>4052</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Markus Gerber, PD Dr. phil</last_name>
      <phone>061 377 87 83</phone>
      <email>markus.gerber@unibas.ch</email>
    </contact>
    <investigator>
      <last_name>Catherine Elliot, Dr. phil.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <link>
    <url>https://dsbg.unibas.ch/</url>
    <description>University of Basel, Department for Sport, Exercise and Health</description>
  </link>
  <link>
    <url>http://www.ukbb.ch/</url>
    <description>University of Basel Childrens Hospital</description>
  </link>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 8, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>October 20, 2014</last_update_submitted>
  <last_update_submitted_qc>October 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Basel</investigator_affiliation>
    <investigator_full_name>Catherine Elliot</investigator_full_name>
    <investigator_title>Dr. Catherine Elliot</investigator_title>
  </responsible_party>
  <keyword>Aerobic Exercise</keyword>
  <keyword>Exercise</keyword>
  <keyword>Exergame</keyword>
  <keyword>Behavior</keyword>
  <keyword>Video Game</keyword>
  <keyword>Inflammatory Bowel Disease</keyword>
  <keyword>Children</keyword>
  <keyword>Adolescents</keyword>
  <keyword>Pediatric</keyword>
  <keyword>Physical Fitness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
    <mesh_term>Depression</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/NCT02264275
org study id: DSBG-UniBasel-Ex-CED-2014-220
nct id: NCT02264275
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine if aerobic exercise training can serve as
      comprehensive palliative care, whereby enhancing cardiovascular fitness, mitigating
      depressive symptoms and augmenting sleep while bolstering health related quality of life in
      youth with Crohn's Disease and Ulcerative Colitis.
An AET intervention is designed to increase the aerobic fitness levels of IBD sufferers
      through daily activity, which is notably lower in this population and could be beneficial for
      sufferers managing this lifelong disease. With an increase in physical activity, the exergame
      aims to introduce, instill and integrate daily physical activity in the lives of IBD
      sufferers. The Just Dance Kids exergame for Nintendo Wii employs moderate intensity physical
      activity and is well suited for this study. The exergame intervention protocol will comprise
      a ramped duration aerobic exercise training starting with 10 minutes in week 1 and rises to
      30 minutes per session in weeks 5 through 8. Just Dance Kids will be used by participants
      under the age of 11 and Just Dance for participants over the age of 10 due to the age
      appropriate dancing skill required in each game. The aim is to determine if this moderate
      intensity, 5 times per week exercise could decrease IBD flare-ups, improve cardiovascular
      fitness, reduce depressive symptoms, improve quality and quantity of sleep and improve the
      health-related quality of life in children and adolescents with IBD.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Pediatric Disease Activity Index
time frame: 8 Weeks
description: Uses either Crohn's Disease or Ulcerative Colitis Disease Activity Index respective to the patient's disease
measure: Sleep
time frame: 8 Weeks
description: Uses Insomnia Severity Index and Daily Sleep Log
measure: Depressive Symptomology
time frame: 8 Weeks
description: Uses Child-S or Des-Teen with respect to participants age
measure: Health Related Quality of Life
time frame: 8 Weeks
description: KIDSCREEN-27
measure: Estimation of Vo2Max
time frame: 8 Weeks
description: Uses the Astrand-Rhyming cycle ergometer protocol
arm group label: Aerobic Exercise Training
arm group type: Experimental
description: An 8-week Nintendo Wii at-home dancing exergame Intervention
intervention type: Behavioral
intervention name: Aerobic Exercise Training
description: The aerobic exercise training uses a television attached to a Nintendo Wii videogame console with a dance game to be played by participants on 5 days per week using a ramped-duration schedule (from 10-30 minutes of moderate physical activity daily).
arm group label: Aerobic Exercise Training
other name: Nintendo Wii
other name: Exergame
other name: Dance Videogame
criteria: 
gender: All
minimum age: 7 Years
maximum age: 20 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Catherine A Elliot, Dr. phil.
role: Principal Investigator
affiliation: University of Basel
last name: Catherine A Elliot, Dr. phil.
phone: 0041 (0)61 377 87 80
email: catherine.elliot@unibas.ch
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Switzerland
url: https://dsbg.unibas.ch/
description: University of Basel, Department for Sport, Exercise and Health
url: http://www.ukbb.ch/
description: University of Basel Childrens Hospital
responsible party type: Principal Investigator
investigator affiliation: University of Basel
investigator full name: Catherine Elliot
investigator title: Dr. Catherine Elliot
mesh term: Crohn Disease
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases
mesh term: Depression