<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/NCT02216604</url>
  </required_header>
  <id_info>
    <org_study_id>S105-2011</org_study_id>
    <nct_id>NCT02216604</nct_id>
  </id_info>
  <brief_title>Exercise in Pediatric Cancer Patient Undergoing Anti-Cancer Treatment</brief_title>
  <acronym>ONKOKIDS-HD</acronym>
  <official_title>Physical Activity Intervention Program for Childhood Cancer Patients Under Chemo- and/or Radiation Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>German Cancer Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital Heidelberg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Heidelberg University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Leipzig</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Medical Hospital, University of Leipzig, Leipzig, Germany</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>German Cancer Research Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Today about 80% childhood cancer patients become long-time survivors. In spite of the high&#xD;
      cure rates the diagnosis cancer is associated with a variety of disease and treatment-related&#xD;
      psychological and physical impairments mostly present into adulthood. So the attention has to&#xD;
      focus on the improvement of these problems such as motor limitation, dysfunction of the&#xD;
      cardiovascular system, reduced muscle strength, overweight, osteoporosis and diminished&#xD;
      quality of life (Qol). Although exercisel intervention studies in this field are generally&#xD;
      scarce, the results of these studies are promising. Up to now studies during the acute phase&#xD;
      of treatment are missing almost completely. The aim of this feasibility study is to evaluate&#xD;
      the potential benefits of a modular exercise intervention program for childhood cancer&#xD;
      patients startunf in parallel with treatment and longlasting for one year. Across two years&#xD;
      cancer patients of the Children's Hospital of the University Clinic of Heidelberg aged 5-21&#xD;
      years, free of any contraindications for physical activity will be recruited. All&#xD;
      participants are asked to complete a physical assessment battery (strength, endurance and&#xD;
      balance capacity, posture control, functional mobility, range of motion) and additionally two&#xD;
      questionnaires concerning Qol and motivation, at baseline and every three months following&#xD;
      one year&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2011</start_date>
  <completion_date type="Actual">March 2019</completion_date>
  <primary_completion_date type="Actual">December 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility after 6 month</measure>
    <time_frame>after primary treatment (6 month)</time_frame>
    <description>Will be measured as the proportion of patients following the exercise prescription.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical performance</measure>
    <time_frame>after primary treatment (6 month) and after one year</time_frame>
    <description>Strength (handheld dynamometer), endurance and balance capacity (TUDS, one leg stand), postural control functional mobility (posturomed &amp; force plate), range of motion (goniometer)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>after primary treatment (6 month) and after one year</time_frame>
    <description>KINDL questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility between 6 and 12 month</measure>
    <time_frame>between end of primary treatment (6 month) and one year</time_frame>
    <description>Will be measured as the proportion of patients following the exercise prescription.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Childhood Cancer</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multimodal Exercise intervention (console-based training, age-specific resistance training and body awareness)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>age, disease and gender matched</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Multimodal Exercise Intervention</intervention_name>
    <description>During their inpatient hospitalization the participants perform 3-5x weekly guided training sessions about 15-30min. The intervention includes: game console-based training using Nintendo Wii® (endurance, strength endurance and balance), age-specific resistance training and sessions of body awareness. During the outpatient phases the participants perform a home-based exercise training 3-5x weekly using a training manual. In addition, the patients obtain a movement diary and a pedometer for documenting their activity level.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pediatric cancer diagnosis (primary leukemia, brain tumors and bone tumors&#xD;
&#xD;
          -  date of diagnosis not longer than 8 weeks ago&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe cardiac impairment&#xD;
&#xD;
          -  bone metastasis inducing skeletal fragility&#xD;
&#xD;
          -  other orthopedic diseases or any other circumstance that would impede ability to give&#xD;
             informed consent or adherence to study requirements.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joachim Wiskemann, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Center for Tumor Diseases</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital of the University Hospital of Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>March 11, 2019</last_update_submitted>
  <last_update_submitted_qc>March 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Exercise</keyword>
  <keyword>Pediatric oncology</keyword>
  <keyword>Physical Performance</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Feasibility</keyword>
  <keyword>during primary</keyword>
  <keyword>anticancer treatment</keyword>
  <!-- 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/NCT02216604
org study id: S105-2011
nct id: NCT02216604
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Today about 80% childhood cancer patients become long-time survivors. In spite of the high
      cure rates the diagnosis cancer is associated with a variety of disease and treatment-related
      psychological and physical impairments mostly present into adulthood. So the attention has to
      focus on the improvement of these problems such as motor limitation, dysfunction of the
      cardiovascular system, reduced muscle strength, overweight, osteoporosis and diminished
      quality of life (Qol). Although exercisel intervention studies in this field are generally
      scarce, the results of these studies are promising. Up to now studies during the acute phase
      of treatment are missing almost completely. The aim of this feasibility study is to evaluate
      the potential benefits of a modular exercise intervention program for childhood cancer
      patients startunf in parallel with treatment and longlasting for one year. Across two years
      cancer patients of the Children's Hospital of the University Clinic of Heidelberg aged 5-21
      years, free of any contraindications for physical activity will be recruited. All
      participants are asked to complete a physical assessment battery (strength, endurance and
      balance capacity, posture control, functional mobility, range of motion) and additionally two
      questionnaires concerning Qol and motivation, at baseline and every three months following
      one year
allocation: Non-Randomized
intervention model: Factorial Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Feasibility after 6 month
time frame: after primary treatment (6 month)
description: Will be measured as the proportion of patients following the exercise prescription.
measure: Physical performance
time frame: after primary treatment (6 month) and after one year
description: Strength (handheld dynamometer), endurance and balance capacity (TUDS, one leg stand), postural control functional mobility (posturomed & force plate), range of motion (goniometer)
measure: Quality of Life
time frame: after primary treatment (6 month) and after one year
description: KINDL questionnaire
measure: Feasibility between 6 and 12 month
time frame: between end of primary treatment (6 month) and one year
description: Will be measured as the proportion of patients following the exercise prescription.
arm group label: Intervention group
arm group type: Experimental
description: Multimodal Exercise intervention (console-based training, age-specific resistance training and body awareness)
arm group label: Control
arm group type: No Intervention
description: age, disease and gender matched
intervention type: Behavioral
intervention name: Multimodal Exercise Intervention
description: During their inpatient hospitalization the participants perform 3-5x weekly guided training sessions about 15-30min. The intervention includes: game console-based training using Nintendo Wii® (endurance, strength endurance and balance), age-specific resistance training and sessions of body awareness. During the outpatient phases the participants perform a home-based exercise training 3-5x weekly using a training manual. In addition, the patients obtain a movement diary and a pedometer for documenting their activity level.
arm group label: Intervention group
criteria: 
gender: All
minimum age: 5 Years
maximum age: 21 Years
healthy volunteers: No
last name: Joachim Wiskemann, PhD
role: Principal Investigator
affiliation: National Center for Tumor Diseases
facility: 
country: Germany
responsible party type: Sponsor