<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/NCT02221986</url>
  </required_header>
  <id_info>
    <org_study_id>S-20140108</org_study_id>
    <nct_id>NCT02221986</nct_id>
  </id_info>
  <brief_title>Interdisciplinary Rehabilitation of Patients With Glioma During Anti-cancer Treatment</brief_title>
  <official_title>Interdisciplinary Rehabilitation of Patients With Glioma During Anti-cancer Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Odense University Hospital</source>
  <brief_summary>
    <textblock>
      The results of the present RCT study will add to the growing body of literature investigating&#xD;
      the potential role of exercise as a supportive therapeutic intervention for patient with&#xD;
      glioma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gliomas are the most frequent primary neoplasm in the CNS and according to the World Health&#xD;
      Organization histologically categorized into low-grade glioma (LGG) (WHO grades I/II) or&#xD;
      high-grade glioma (HGG) (WHO grades III/IV). Gliomas are among the biggest challenges within&#xD;
      the field of neuro-rehabilitation and oncology, and optimising treatment by improving QoL,&#xD;
      function and cognition is of major clinical importance in this population. Because the&#xD;
      majority of patients cannot be cured, clinical cancer research traditionally have focused on&#xD;
      prolonging survival, exposing relapse or optimising the response to the medical treatment.&#xD;
      Today there is a general consensus that health-related quality of life (HRQoL) is important&#xD;
      in the evaluation of new treatments. However, research in HRQoL among patients with gliomas&#xD;
      is scarce compared to the other categories of patients with tumors. In recent years have&#xD;
      exercise become an important part of cancer treatment. The effects is well documented in&#xD;
      studies among other cancer patients than gliomas and includes improvements of quality of&#xD;
      life, physical function, reduce fatigue and thereby supports daily activities among cancer&#xD;
      patients'. Inpatient rehabilitation studies among glioma patients have also indicated&#xD;
      improved HRQoL and functional measurements such as activity of daily life, mobility and&#xD;
      cognition. Despite of this rehabilitation efforts is still not emphasized in this population&#xD;
      and recent literature concludes that there are no well-designed clinical studies examining&#xD;
      the effect of multidisciplinary rehabilitation among Glioma patients. This study is the first&#xD;
      to investigate the effect of an intensive specialised interdisciplinary outpatient&#xD;
      rehabilitation program among gliomas patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2015</start_date>
  <completion_date type="Actual">February 14, 2018</completion_date>
  <primary_completion_date type="Actual">February 14, 2018</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>Health related quality of life</measure>
    <time_frame>Change from Baseline HRQoL at 6 months</time_frame>
    <description>Questionnaires EORTC-QLQ-30 &amp; BN-20</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Symptom burden</measure>
    <time_frame>Change from Baseline Symptom burden at 6 months</time_frame>
    <description>Assessed through EORTC-QLQ-30 &amp; BN-20</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity levels</measure>
    <time_frame>Change from Baseline Physical activity levels at 6 months</time_frame>
    <description>Physical activity at work and leisure time ( Assessed through questionnaire by Saltin and Grimsby 1968 and Physical Activity Scale)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle strength</measure>
    <time_frame>Change from Baseline Musclestrength at 3 months</time_frame>
    <description>Assessed through 3-8 submax repetition maximum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VO2peak</measure>
    <time_frame>Change from Baseline VO2peak at 3 months</time_frame>
    <description>Assessed through Åstrand 1-pkt. cycle test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Balance</measure>
    <time_frame>Change from Baseline Balance at 3 months</time_frame>
    <description>Assessed through wii balance board</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gait function</measure>
    <time_frame>Change from Baseline gait function at 3 months</time_frame>
    <description>Assessed through 10 meter walk test. Time and step frequency.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity levels</measure>
    <time_frame>Change from Baseline Activity levels at 3 months</time_frame>
    <description>Assessed through questionnaire (Impact on Participation and Autonomy)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Neoplasms</condition>
  <condition>CNS Neoplasms</condition>
  <arm_group>
    <arm_group_label>Interdisciplinary rehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention consists of 6 weeks intensive outpatient physiotherapy in conjunction with 0-6 weeks of occupational therapy if need is indicated. The physical intervention contains supervised group exercise of 90 minutes three times a week in groups up to four patients included continuously.&#xD;
The occupational therapy intervention consists of individual training 60 minutes twice a week for patients having deficits in activity or participation levels measured by the Assessment of Motor and Process Skills (AMPS).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Care as usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group receives usual standard of care (e.g. no training, individual training or group training in the municipality). The amount of training in this group is based on a questionnaire at the follow-up trials.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Interdisciplinary rehabilitation</intervention_name>
    <arm_group_label>Interdisciplinary rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of primary glioma (WHO grades I-IV)&#xD;
&#xD;
          -  Age ≥ 18&#xD;
&#xD;
          -  Reference with diagnosis or treatment at Odense University Hospital&#xD;
&#xD;
          -  Karnofsky performance score (KPS) ≥70&#xD;
&#xD;
          -  Ability to understand Danish.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Known psychiatric diagnosis or substance abuse&#xD;
&#xD;
          -  Heart problems excluding intense exercise (NYHA group III and IV)&#xD;
&#xD;
          -  Pronounced impressive/expressive aphasia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karen Søgaard, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>University of Southern Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <state>Funen</state>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>April 3, 2018</last_update_submitted>
  <last_update_submitted_qc>April 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Odense University Hospital</investigator_affiliation>
    <investigator_full_name>Anders Hansen</investigator_full_name>
    <investigator_title>Physiotherapist, Master of Health Science</investigator_title>
  </responsible_party>
  <keyword>Interdisciplinary rehabilitation</keyword>
  <keyword>Neurooncology</keyword>
  <keyword>Physiotherapy</keyword>
  <keyword>Occupational therapy</keyword>
  <keyword>Neurorehabilitation</keyword>
  <keyword>Glioma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Glioma</mesh_term>
    <mesh_term>Central Nervous System Neoplasms</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/NCT02221986
org study id: S-20140108
nct id: NCT02221986
lead sponsor: 
collaborator: 
The results of the present RCT study will add to the growing body of literature investigating
      the potential role of exercise as a supportive therapeutic intervention for patient with
      glioma.
Gliomas are the most frequent primary neoplasm in the CNS and according to the World Health
      Organization histologically categorized into low-grade glioma (LGG) (WHO grades I/II) or
      high-grade glioma (HGG) (WHO grades III/IV). Gliomas are among the biggest challenges within
      the field of neuro-rehabilitation and oncology, and optimising treatment by improving QoL,
      function and cognition is of major clinical importance in this population. Because the
      majority of patients cannot be cured, clinical cancer research traditionally have focused on
      prolonging survival, exposing relapse or optimising the response to the medical treatment.
      Today there is a general consensus that health-related quality of life (HRQoL) is important
      in the evaluation of new treatments. However, research in HRQoL among patients with gliomas
      is scarce compared to the other categories of patients with tumors. In recent years have
      exercise become an important part of cancer treatment. The effects is well documented in
      studies among other cancer patients than gliomas and includes improvements of quality of
      life, physical function, reduce fatigue and thereby supports daily activities among cancer
      patients'. Inpatient rehabilitation studies among glioma patients have also indicated
      improved HRQoL and functional measurements such as activity of daily life, mobility and
      cognition. Despite of this rehabilitation efforts is still not emphasized in this population
      and recent literature concludes that there are no well-designed clinical studies examining
      the effect of multidisciplinary rehabilitation among Glioma patients. This study is the first
      to investigate the effect of an intensive specialised interdisciplinary outpatient
      rehabilitation program among gliomas patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Health related quality of life
time frame: Change from Baseline HRQoL at 6 months
description: Questionnaires EORTC-QLQ-30 & BN-20
measure: Symptom burden
time frame: Change from Baseline Symptom burden at 6 months
description: Assessed through EORTC-QLQ-30 & BN-20
measure: Physical activity levels
time frame: Change from Baseline Physical activity levels at 6 months
description: Physical activity at work and leisure time ( Assessed through questionnaire by Saltin and Grimsby 1968 and Physical Activity Scale)
measure: Muscle strength
time frame: Change from Baseline Musclestrength at 3 months
description: Assessed through 3-8 submax repetition maximum
measure: VO2peak
time frame: Change from Baseline VO2peak at 3 months
description: Assessed through Åstrand 1-pkt. cycle test.
measure: Balance
time frame: Change from Baseline Balance at 3 months
description: Assessed through wii balance board
measure: Gait function
time frame: Change from Baseline gait function at 3 months
description: Assessed through 10 meter walk test. Time and step frequency.
measure: Activity levels
time frame: Change from Baseline Activity levels at 3 months
description: Assessed through questionnaire (Impact on Participation and Autonomy)
arm group label: Interdisciplinary rehabilitation
arm group type: Experimental
description: The intervention consists of 6 weeks intensive outpatient physiotherapy in conjunction with 0-6 weeks of occupational therapy if need is indicated. The physical intervention contains supervised group exercise of 90 minutes three times a week in groups up to four patients included continuously.
The occupational therapy intervention consists of individual training 60 minutes twice a week for patients having deficits in activity or participation levels measured by the Assessment of Motor and Process Skills (AMPS).
arm group label: Care as usual
arm group type: No Intervention
description: The control group receives usual standard of care (e.g. no training, individual training or group training in the municipality). The amount of training in this group is based on a questionnaire at the follow-up trials.
intervention type: Behavioral
intervention name: Interdisciplinary rehabilitation
arm group label: Interdisciplinary rehabilitation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Karen Søgaard, Professor
role: Study Chair
affiliation: University of Southern Denmark
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Odense University Hospital
investigator full name: Anders Hansen
investigator title: Physiotherapist, Master of Health Science
mesh term: Neoplasms
mesh term: Glioma
mesh term: Central Nervous System Neoplasms