<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/NCT03775369</url>
  </required_header>
  <id_info>
    <org_study_id>2018-01314; ch18Cordier</org_study_id>
    <nct_id>NCT03775369</nct_id>
  </id_info>
  <brief_title>Glioma and Exercising</brief_title>
  <official_title>Influence of Physical Activity in Patients With High Grade Glioma (WHO III° and IV°) on Patients' Psychological Well Being, Sleep and Quality of Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Basel, Department of Sport, Exercise and Health, Division of Sport Science and Psychosocial Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</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>
      To investigate the influence of two physical activity and exercising (PAE) interventions,&#xD;
      namely resistance training and endurance training in relation to quality of life, depression,&#xD;
      fatigue, sleep, anxiety, stress and coping, body image, and social interactions&#xD;
      (psychological dimensions); cardiorespiratory fitness, morning cortisol secretion,&#xD;
      inflammatory markers, and objective sleep (physiological dimensions), along with&#xD;
      cancer-related dimensions&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with high grade glioma (WHO III° and IV°) and undergoing radiotherapy, chemotherapy,&#xD;
      or both radio- and chemotherapy suffer from decreased quality of life (QoL). This study is to&#xD;
      analyse the influence of two adjuvant interventions of physical activity and exercising (PAE)&#xD;
      (namely resistance training and endurance training) in relation to quality of life,&#xD;
      depression, fatigue, sleep, anxiety, stress and coping, body image, and social interactions&#xD;
      (psychological dimensions); cardiorespiratory fitness, morning cortisol secretion,&#xD;
      inflammatory markers, and objective sleep (physiological dimensions).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 26, 2018</start_date>
  <completion_date type="Actual">February 28, 2022</completion_date>
  <primary_completion_date type="Actual">February 28, 2022</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 Functional Assessment of Cancer Therapy Scale (FACT)</measure>
    <time_frame>Baseline and week 3 and week 6</time_frame>
    <description>Cancer-related Quality of Life (QOL) assessed by Functional Assessment of Cancer Therapy Scale (FACT), a self-report instrument which measures multidimensional QOL. The FACT evaluation system uses a 29-49 item compilation of a generic core and numerous subscales (9-20 items each) which reflect symptoms associated with different diseases, symptom complexes and treatments.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Hamilton Depression Rating Scale (HDRS)</measure>
    <time_frame>Baseline and week 3 and week 6</time_frame>
    <description>HDRS scale to assess patients' severity of Depression (mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms); each item on the questionnaire is scored on a 3 or 5 point scale; a score of 0-7 is considered to be normal</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Intolerance of Uncertainty Scale (IU)</measure>
    <time_frame>Baseline and week 3 and week 6</time_frame>
    <description>IU: 5-point rating scale (1 = not at all characteristic of me, 5 = entirely characteristic of me) indicating how much patient agrees with the item. The higher the overall score is, the more the respondent is assumed to be more intolerant of uncertainty</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Insomnia Severity Index (ISI)</measure>
    <time_frame>Baseline and week 3 and week 6</time_frame>
    <description>ISI is a 7-item screening measure for insomnia. Items answered on 5-point rating scales (0 = not at all, 4 = very much)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Perceived Stress Scale (PSS)</measure>
    <time_frame>Baseline and week 3 and week 6</time_frame>
    <description>General perceived stress is assessed with the 10-item Perceived Stress Scale (PSS). The PSS measures the degree to which respondents find their lives unpredictable, uncontrollable and overloading. Answers were given on a five-point Likert-type scale anchored at 1 (never) to 5 (very often). Four items were reverse scored. The mean was calculated in order to obtain an overall score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Fatigue Severity Scale</measure>
    <time_frame>Baseline and week 3 and week 6</time_frame>
    <description>nine items, and answers are given on seven-point rating scales ranging from 1 (not at all) to 7 (definitively/almost always), with higher mean scores reflecting greater fatigue</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Mental Toughness Questionnaire (MTQ48)</measure>
    <time_frame>Baseline and week 3 and week 6</time_frame>
    <description>The 48 item MTQ48 measures the subcomponents challenge, commitment, emotional and life control, and interpersonal confidence and confidence in ability. Answers are given on five-point Likert-type scales ranging from 1 (=strongly disagree) to 5 (=strongly agree), with higher scores reflecting greater MT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in International Physical Activity Questionnaire</measure>
    <time_frame>Baseline and week 3 and week 6</time_frame>
    <description>questionnaire consists of several items and asks about the amount of days with walking, moderate and vigorous physical activity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in submaximal 6-min walking test (6MWT)</measure>
    <time_frame>Baseline and week 3 and week 6</time_frame>
    <description>To assess functional exercise capacity, distance walked during 6 min will be assessed and compared to reference age and gender norms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Grip force</measure>
    <time_frame>Baseline and week 3 and week 6</time_frame>
    <description>Maximum isometric grip force of the dominant hand is assessed using the hand dynamometer. Participants make three attempts. Mean outcomes is compared to reference data</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in sleep continuity assessed by EEG</measure>
    <time_frame>Baseline and week 6</time_frame>
    <description>Sleep is objectively assessed via an easy-to-use in-home sleep-EEG. It consists of three electrodes and measures sleep continuity (awakenings after sleep onset: number of duration of awakenings)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in C reactive protein (CRP) (mg/l)</measure>
    <time_frame>Baseline and week 6</time_frame>
    <description>blood samples are taken before and after the 6MWT and grip force test to assess inflammatory marker CRP (mg/l)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in sleep architecture (min; %)</measure>
    <time_frame>Baseline and week 6</time_frame>
    <description>Sleep is objectively assessed via an easy-to-use in-home sleep-EEG. It consists of three electrodes and measures sleep architecture (wake, Non-rapid eye movement (REM)- sleep stages 1-4 (min; %); REM-sleep (min; %).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>High Grade Glioma</condition>
  <arm_group>
    <arm_group_label>Endurance training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Endurance Training (warm-up; endurance on bike; brisk walking; cooling down; group sessions; supervised; moderate and individualized exercising load):&#xD;
6 weeks, 2 sessions/week, 40-60min/session</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resistance training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Resistance Training (warm-up; resistance training units; cooling down; group sessions; supervised; moderate and individualized exercising load):&#xD;
6 weeks, 2 sessions/week, 40-60min/session</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control condition</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control condition (individualized counselling, but not intended as a bona fide intervention, that is to say: not intended to actively improve participants' well-being):&#xD;
6 weeks, social support and counseling,1-2 sessions/week; 30 min/session</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>endurance training</intervention_name>
    <description>physical activity and exercising (PAE)</description>
    <arm_group_label>Endurance training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>social support and counseling</intervention_name>
    <description>social support and counseling</description>
    <arm_group_label>Control condition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>resistance training</intervention_name>
    <description>physical activity and exercising (PAE)</description>
    <arm_group_label>Resistance training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with high grade glioma (WHO III° and IV°), and undergoing radiotherapy,&#xD;
             chemotherapy, or both&#xD;
&#xD;
          -  Willing and able to follow the study intervention&#xD;
&#xD;
          -  Signed written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe psychiatric (psychosis, suicidal behavior, substance use disorder) and somatic&#xD;
             comorbidities (severe cardiovascular disease, severe diabetes, impairments of the&#xD;
             musculo-skeletal system)&#xD;
&#xD;
          -  patients not willing or able anymore to follow the study protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Serge Brand, PD Dr. phil</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Sport, Exercise and Health, University of Basel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Basel, Department of Neurosurgery</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Sport, Exercise and Health, University of Basel</name>
      <address>
        <city>Basel</city>
        <zip>4052</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>May 17, 2022</last_update_submitted>
  <last_update_submitted_qc>May 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>interventions of physical activity and exercising (PAE)</keyword>
  <keyword>resistance training</keyword>
  <keyword>endurance training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioma</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/NCT03775369
org study id: 2018-01314; ch18Cordier
nct id: NCT03775369
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To investigate the influence of two physical activity and exercising (PAE) interventions,
      namely resistance training and endurance training in relation to quality of life, depression,
      fatigue, sleep, anxiety, stress and coping, body image, and social interactions
      (psychological dimensions); cardiorespiratory fitness, morning cortisol secretion,
      inflammatory markers, and objective sleep (physiological dimensions), along with
      cancer-related dimensions
Patients with high grade glioma (WHO III° and IV°) and undergoing radiotherapy, chemotherapy,
      or both radio- and chemotherapy suffer from decreased quality of life (QoL). This study is to
      analyse the influence of two adjuvant interventions of physical activity and exercising (PAE)
      (namely resistance training and endurance training) in relation to quality of life,
      depression, fatigue, sleep, anxiety, stress and coping, body image, and social interactions
      (psychological dimensions); cardiorespiratory fitness, morning cortisol secretion,
      inflammatory markers, and objective sleep (physiological dimensions).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in Functional Assessment of Cancer Therapy Scale (FACT)
time frame: Baseline and week 3 and week 6
description: Cancer-related Quality of Life (QOL) assessed by Functional Assessment of Cancer Therapy Scale (FACT), a self-report instrument which measures multidimensional QOL. The FACT evaluation system uses a 29-49 item compilation of a generic core and numerous subscales (9-20 items each) which reflect symptoms associated with different diseases, symptom complexes and treatments.
measure: Change in Hamilton Depression Rating Scale (HDRS)
time frame: Baseline and week 3 and week 6
description: HDRS scale to assess patients' severity of Depression (mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms); each item on the questionnaire is scored on a 3 or 5 point scale; a score of 0-7 is considered to be normal
measure: Change in Intolerance of Uncertainty Scale (IU)
time frame: Baseline and week 3 and week 6
description: IU: 5-point rating scale (1 = not at all characteristic of me, 5 = entirely characteristic of me) indicating how much patient agrees with the item. The higher the overall score is, the more the respondent is assumed to be more intolerant of uncertainty
measure: Change in Insomnia Severity Index (ISI)
time frame: Baseline and week 3 and week 6
description: ISI is a 7-item screening measure for insomnia. Items answered on 5-point rating scales (0 = not at all, 4 = very much)
measure: Change in Perceived Stress Scale (PSS)
time frame: Baseline and week 3 and week 6
description: General perceived stress is assessed with the 10-item Perceived Stress Scale (PSS). The PSS measures the degree to which respondents find their lives unpredictable, uncontrollable and overloading. Answers were given on a five-point Likert-type scale anchored at 1 (never) to 5 (very often). Four items were reverse scored. The mean was calculated in order to obtain an overall score.
measure: Change in Fatigue Severity Scale
time frame: Baseline and week 3 and week 6
description: nine items, and answers are given on seven-point rating scales ranging from 1 (not at all) to 7 (definitively/almost always), with higher mean scores reflecting greater fatigue
measure: Change in Mental Toughness Questionnaire (MTQ48)
time frame: Baseline and week 3 and week 6
description: The 48 item MTQ48 measures the subcomponents challenge, commitment, emotional and life control, and interpersonal confidence and confidence in ability. Answers are given on five-point Likert-type scales ranging from 1 (=strongly disagree) to 5 (=strongly agree), with higher scores reflecting greater MT
measure: Change in International Physical Activity Questionnaire
time frame: Baseline and week 3 and week 6
description: questionnaire consists of several items and asks about the amount of days with walking, moderate and vigorous physical activity.
measure: Change in submaximal 6-min walking test (6MWT)
time frame: Baseline and week 3 and week 6
description: To assess functional exercise capacity, distance walked during 6 min will be assessed and compared to reference age and gender norms
measure: Change in Grip force
time frame: Baseline and week 3 and week 6
description: Maximum isometric grip force of the dominant hand is assessed using the hand dynamometer. Participants make three attempts. Mean outcomes is compared to reference data
measure: Change in sleep continuity assessed by EEG
time frame: Baseline and week 6
description: Sleep is objectively assessed via an easy-to-use in-home sleep-EEG. It consists of three electrodes and measures sleep continuity (awakenings after sleep onset: number of duration of awakenings)
measure: Change in C reactive protein (CRP) (mg/l)
time frame: Baseline and week 6
description: blood samples are taken before and after the 6MWT and grip force test to assess inflammatory marker CRP (mg/l)
measure: Change in sleep architecture (min; %)
time frame: Baseline and week 6
description: Sleep is objectively assessed via an easy-to-use in-home sleep-EEG. It consists of three electrodes and measures sleep architecture (wake, Non-rapid eye movement (REM)- sleep stages 1-4 (min; %); REM-sleep (min; %).
arm group label: Endurance training
arm group type: Active Comparator
description: Endurance Training (warm-up; endurance on bike; brisk walking; cooling down; group sessions; supervised; moderate and individualized exercising load):
6 weeks, 2 sessions/week, 40-60min/session
arm group label: Resistance training
arm group type: Active Comparator
description: Resistance Training (warm-up; resistance training units; cooling down; group sessions; supervised; moderate and individualized exercising load):
6 weeks, 2 sessions/week, 40-60min/session
arm group label: Control condition
arm group type: Active Comparator
description: Control condition (individualized counselling, but not intended as a bona fide intervention, that is to say: not intended to actively improve participants' well-being):
6 weeks, social support and counseling,1-2 sessions/week; 30 min/session
intervention type: Other
intervention name: endurance training
description: physical activity and exercising (PAE)
arm group label: Endurance training
intervention type: Other
intervention name: social support and counseling
description: social support and counseling
arm group label: Control condition
intervention type: Other
intervention name: resistance training
description: physical activity and exercising (PAE)
arm group label: Resistance training
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Serge Brand, PD Dr. phil
role: Principal Investigator
affiliation: Department of Sport, Exercise and Health, University of Basel
facility: 
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Glioma