<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/NCT02970825</url>
  </required_header>
  <id_info>
    <org_study_id>Etude 2016/17FEV/060</org_study_id>
    <nct_id>NCT02970825</nct_id>
  </id_info>
  <brief_title>Move and Feel Good : Effects of Intensive Physical Training on Brain Plasticity, Cognition and Psychological Well-being.</brief_title>
  <acronym>Move&amp;FG</acronym>
  <official_title>Move and Feel Good : Effects of Intensive Physical Training on Brain Plasticity, Cognition and Psychological Well-being. &quot;Effets de l'entraînement Physique Intensif Sur la plasticité cérébrale, la Cognition et le Bien être Psychologique&quot;.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Université Catholique de Louvain</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Université Catholique de Louvain</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators perform a prospective, randomized, clinical study involving students in&#xD;
      education with mood disorders and randomized to an intensive exercise program or a control&#xD;
      relaxation activity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators wish to document the benefit of an intensive and structured exercise&#xD;
      program in youth with the aim to identify the most effective programs that can improve&#xD;
      psychological well-being, especially reducing depressive and anxiety symptoms and improving&#xD;
      self-esteem. This study targets participants aged 9 to 30 years and included in an education&#xD;
      program (from 4th Grade to undergraduate university or college). The investigators propose to&#xD;
      perform a prospective, randomized, clinical study involving participants with mood disorders&#xD;
      (International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM)&#xD;
      for medical coding: ICD-10-CM F32.9), anxiety (ICD-10-CM F41.9), specific learning&#xD;
      disabilities (ADHD hyperactivity (ICD-10-CM F90.2), dyslexia-dyscalculia-dyspraxia (ICD-10-CM&#xD;
      F81.0, F81.2, F81.81)) and healthy subjects equally distributed for confounding variables&#xD;
      (age, gender, subclinical or clinical depressive symptoms). The participants (ambulatory or&#xD;
      inpatients) will be enrolled either in an experimental, intensive and structured aerobic&#xD;
      exercise regime or in a active control activity of stretching and relaxation conducted in&#xD;
      parallel. The effects of this program will be assessed for i) psychological symptoms, using&#xD;
      questionnaires, ii) cognitive function, particularly attention skills and executive&#xD;
      functions, in neuropsychological tasks, and iii) physical abilities (through physical&#xD;
      testing). To investigate the therapeutic value of exercise in the prevention of depressive&#xD;
      and anxiety symptoms and in the treatment of mood disorders in the young student is a&#xD;
      necessity imposed by the current outbreak of depression among adolescents and young people at&#xD;
      school. To promote the exercise medicine based on the level of evidence in this specific&#xD;
      domain, rigorous experimental studies must be performed. Depending on the results, a medical&#xD;
      imaging will be proposed to participants at the end of the behavioral study. This will be a&#xD;
      functional magnetic resonance imaging in physiological activation condition (performing a&#xD;
      behavioral task such as a Stroop task suited to the subject's age), performed before and&#xD;
      after intensive physical training.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">November 18, 2021</completion_date>
  <primary_completion_date type="Anticipated">November 18, 2021</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>
    <intervention_model_description>Two experimental arms: physical training and relaxation program, including social activities. Both programs are conducted in parallel with adolescents and young people.&#xD;
A first study was conducted among schoolchildren and was published. The second study was conducted in a clinical population of Area + -Fond'Roy psychiatric hospital in Brussels. Both studies were performed in a parallel order and randomized at the beginning of the study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline psychological well-being as assessed using depression and anxiety questionnaires</measure>
    <time_frame>at 3 weeks, at 6 weeks and through study completion, up to 6 months</time_frame>
    <description>Hospital Anxiety Depression Scale (HADS) in french version for all participants, mainly suitable for inpatients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline psychological well-being as assessed using self-esteem, mood and anxiety questionnaires</measure>
    <time_frame>at 3 weeks, at 6 weeks and through study completion, up to 6 months</time_frame>
    <description>State-Trait Anxiety Inventory (STAI) in french version for all participants, mainly suitable for outpatients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline psychological well-being as assessed using depression questionnaires for children</measure>
    <time_frame>at 3 weeks, at 6 weeks and through study completion, up to 6 months</time_frame>
    <description>Children's Depression Inventory (CDI) in french version</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline psychological well-being as assessed using depression questionnaires for adolescents and adults</measure>
    <time_frame>at 3 weeks, at 6 weeks and through study completion, up to 6 months</time_frame>
    <description>Beck Depression Inventory (BDI-13) in french version</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline psychological well-being as assessed using depression questionnaire for young people and adults</measure>
    <time_frame>at 3 weeks, at 6 weeks and through study completion, up to 6 months</time_frame>
    <description>Self-depression scale (SDS) in french version</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline psychological well-being as assessed using self-esteem questionnaires</measure>
    <time_frame>at 3 weeks, at 6 weeks and through study completion, up to 6 months</time_frame>
    <description>Self-perception profile for children or adolescents in french version</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline physical condition : size</measure>
    <time_frame>at 3 weeks, at 6 weeks and through study completion, up to 6 months</time_frame>
    <description>Height in meters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline physical condition : weight</measure>
    <time_frame>at 3 weeks, at 6 weeks and through study completion, up to 6 months</time_frame>
    <description>Weight in kilograms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline physical condition as assessed in bioelectrical impedance analysis</measure>
    <time_frame>at 3 weeks, at 6 weeks and through study completion, up to 6 months</time_frame>
    <description>Body mass index (BMI) in kilograms divided by the square of the height in meters (kg/m2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline physical condition : body muscle ratio</measure>
    <time_frame>at 3 weeks, at 6 weeks and through study completion, up to 6 months</time_frame>
    <description>Body muscle percentage : {body muscle mass (kg) / total body mass (kg)} x 100</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline physical condition : body fat ratio</measure>
    <time_frame>at 3 weeks, at 6 weeks and through study completion, up to 6 months</time_frame>
    <description>Body fat percentage : {body fat mass (kg) / total body mass (kg)} x 100</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline physical condition as assessed using field running tests or a cycle ergometer</measure>
    <time_frame>at 3 weeks, at 6 weeks and through study completion, up to 6 months</time_frame>
    <description>An estimation of maximal oxygen consumption in field running test (20m-beep test).&#xD;
A submaximal effort test using a cycle ergometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline cognitive function as assessed using computerized neuropsychological testing of cognitive control</measure>
    <time_frame>at 3 weeks, at 6 weeks and through study completion, up to 6 months</time_frame>
    <description>Attention and conflict resolution testing using a variant of the Eriksen Flanker task, adapted for age, in E-Prime.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline cognitive function as assessed using computerized neuropsychological testing of inhibitory control</measure>
    <time_frame>at 3 weeks, at 6 weeks and through study completion, up to 6 months</time_frame>
    <description>Inhibitory control testing using a go-no go test adapted in E-Prime.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Learning Disorders</condition>
  <condition>Depression</condition>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental, intensive exercise regime will include 50-min sessions four times a week during five weeks (for a total of about 17 hours) combining structured aerobic exercise (at least 20 minutes jogging and moderate to high intensity active games) and anaerobic lactic resistance exercise (power training with gymn weights).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Relaxation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control activity will include 50-min sessions four times a week during five weeks (for a total of about 17 hours) combining mindfulness, stretching and low intensity active games (breath control, proprioception, walking, social relaxation, flexibility training).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>Moderate to high intensity physical training</description>
    <arm_group_label>Exercise</arm_group_label>
    <other_name>Physical training</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Relaxation</intervention_name>
    <description>Low intensity physical activity and relaxation</description>
    <arm_group_label>Relaxation</arm_group_label>
    <other_name>Flexibility training</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  involved in education program&#xD;
&#xD;
          -  absence of contra-indication of physical activity&#xD;
&#xD;
          -  does accept randomization&#xD;
&#xD;
          -  no history of neurological illness or brain trauma&#xD;
&#xD;
          -  no history of psychiatric illness (exclusion of psychotic symptoms)&#xD;
&#xD;
          -  absence of contra-indication to magnetic resonance imaging&#xD;
&#xD;
          -  no uncorrected sensory impairment (must understand the therapist)&#xD;
&#xD;
          -  absence of conduct disorders (violence, school bullying)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  does not provide informed consent&#xD;
&#xD;
          -  unstable diabetes&#xD;
&#xD;
          -  Body mass index above P95 (or above 30 for adults) (except medical authorization)&#xD;
&#xD;
          -  coagulation disorders&#xD;
&#xD;
          -  severe and unstable asthma&#xD;
&#xD;
          -  history of hearth malformation or heart disease&#xD;
&#xD;
          -  medical conditions prohibiting sport or contraindicating physical activity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anne G De Volder, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Université Catholique de Louvain</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anne G De Volder, MD, PhD</last_name>
    <phone>+32 2 764 54 82</phone>
    <email>anne.de.volder@uclouvain.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yannick Bleyenheuft, PhD</last_name>
    <email>yannick.bleyenheuft@uclouvain.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Université catholique de Louvain</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anne G De Volder, MD, PhD</last_name>
      <phone>+32 2 764 5482</phone>
      <email>anne.de.volder@uclouvain.be</email>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>October 9, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>October 16, 2020</last_update_submitted>
  <last_update_submitted_qc>October 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Université Catholique de Louvain</investigator_affiliation>
    <investigator_full_name>Anne G. De Volder, MD, PhD</investigator_full_name>
    <investigator_title>MD, PhD, Senior Research Associate</investigator_title>
  </responsible_party>
  <keyword>exercise medicine</keyword>
  <keyword>youth</keyword>
  <keyword>adolescents</keyword>
  <keyword>students</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Learning Disabilities</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>This is a monocentric study. All individual participant data that allow subject identification will be kept confidential.</ipd_description>
  </patient_data>
  <!-- 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/NCT02970825
org study id: Etude 2016/17FEV/060
nct id: NCT02970825
lead sponsor: 
has dmc: No
The investigators perform a prospective, randomized, clinical study involving students in
      education with mood disorders and randomized to an intensive exercise program or a control
      relaxation activity.
The investigators wish to document the benefit of an intensive and structured exercise
      program in youth with the aim to identify the most effective programs that can improve
      psychological well-being, especially reducing depressive and anxiety symptoms and improving
      self-esteem. This study targets participants aged 9 to 30 years and included in an education
      program (from 4th Grade to undergraduate university or college). The investigators propose to
      perform a prospective, randomized, clinical study involving participants with mood disorders
      (International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM)
      for medical coding: ICD-10-CM F32.9), anxiety (ICD-10-CM F41.9), specific learning
      disabilities (ADHD hyperactivity (ICD-10-CM F90.2), dyslexia-dyscalculia-dyspraxia (ICD-10-CM
      F81.0, F81.2, F81.81)) and healthy subjects equally distributed for confounding variables
      (age, gender, subclinical or clinical depressive symptoms). The participants (ambulatory or
      inpatients) will be enrolled either in an experimental, intensive and structured aerobic
      exercise regime or in a active control activity of stretching and relaxation conducted in
      parallel. The effects of this program will be assessed for i) psychological symptoms, using
      questionnaires, ii) cognitive function, particularly attention skills and executive
      functions, in neuropsychological tasks, and iii) physical abilities (through physical
      testing). To investigate the therapeutic value of exercise in the prevention of depressive
      and anxiety symptoms and in the treatment of mood disorders in the young student is a
      necessity imposed by the current outbreak of depression among adolescents and young people at
      school. To promote the exercise medicine based on the level of evidence in this specific
      domain, rigorous experimental studies must be performed. Depending on the results, a medical
      imaging will be proposed to participants at the end of the behavioral study. This will be a
      functional magnetic resonance imaging in physiological activation condition (performing a
      behavioral task such as a Stroop task suited to the subject's age), performed before and
      after intensive physical training.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two experimental arms: physical training and relaxation program, including social activities. Both programs are conducted in parallel with adolescents and young people.
A first study was conducted among schoolchildren and was published. The second study was conducted in a clinical population of Area + -Fond'Roy psychiatric hospital in Brussels. Both studies were performed in a parallel order and randomized at the beginning of the study.
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change from baseline psychological well-being as assessed using depression and anxiety questionnaires
time frame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
description: Hospital Anxiety Depression Scale (HADS) in french version for all participants, mainly suitable for inpatients
measure: Change from baseline psychological well-being as assessed using self-esteem, mood and anxiety questionnaires
time frame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
description: State-Trait Anxiety Inventory (STAI) in french version for all participants, mainly suitable for outpatients
measure: Change from baseline psychological well-being as assessed using depression questionnaires for children
time frame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
description: Children's Depression Inventory (CDI) in french version
measure: Change from baseline psychological well-being as assessed using depression questionnaires for adolescents and adults
time frame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
description: Beck Depression Inventory (BDI-13) in french version
measure: Change from baseline psychological well-being as assessed using depression questionnaire for young people and adults
time frame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
description: Self-depression scale (SDS) in french version
measure: Change from baseline psychological well-being as assessed using self-esteem questionnaires
time frame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
description: Self-perception profile for children or adolescents in french version
measure: Change from baseline physical condition : size
time frame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
description: Height in meters
measure: Change from baseline physical condition : weight
time frame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
description: Weight in kilograms
measure: Change from baseline physical condition as assessed in bioelectrical impedance analysis
time frame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
description: Body mass index (BMI) in kilograms divided by the square of the height in meters (kg/m2)
measure: Change from baseline physical condition : body muscle ratio
time frame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
description: Body muscle percentage : {body muscle mass (kg) / total body mass (kg)} x 100
measure: Change from baseline physical condition : body fat ratio
time frame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
description: Body fat percentage : {body fat mass (kg) / total body mass (kg)} x 100
measure: Change from baseline physical condition as assessed using field running tests or a cycle ergometer
time frame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
description: An estimation of maximal oxygen consumption in field running test (20m-beep test).
A submaximal effort test using a cycle ergometer.
measure: Change from baseline cognitive function as assessed using computerized neuropsychological testing of cognitive control
time frame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
description: Attention and conflict resolution testing using a variant of the Eriksen Flanker task, adapted for age, in E-Prime.
measure: Change from baseline cognitive function as assessed using computerized neuropsychological testing of inhibitory control
time frame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
description: Inhibitory control testing using a go-no go test adapted in E-Prime.
arm group label: Exercise
arm group type: Experimental
description: The experimental, intensive exercise regime will include 50-min sessions four times a week during five weeks (for a total of about 17 hours) combining structured aerobic exercise (at least 20 minutes jogging and moderate to high intensity active games) and anaerobic lactic resistance exercise (power training with gymn weights).
arm group label: Relaxation
arm group type: Active Comparator
description: The control activity will include 50-min sessions four times a week during five weeks (for a total of about 17 hours) combining mindfulness, stretching and low intensity active games (breath control, proprioception, walking, social relaxation, flexibility training).
intervention type: Other
intervention name: Exercise
description: Moderate to high intensity physical training
arm group label: Exercise
other name: Physical training
intervention type: Other
intervention name: Relaxation
description: Low intensity physical activity and relaxation
arm group label: Relaxation
other name: Flexibility training
criteria: 
gender: All
minimum age: 9 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anne G De Volder, MD, PhD
role: Principal Investigator
affiliation: Université Catholique de Louvain
last name: Anne G De Volder, MD, PhD
phone: +32 2 764 54 82
email: anne.de.volder@uclouvain.be
last name: Yannick Bleyenheuft, PhD
email: yannick.bleyenheuft@uclouvain.be
facility: 
status: Recruiting
contact: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Université Catholique de Louvain
investigator full name: Anne G. De Volder, MD, PhD
investigator title: MD, PhD, Senior Research Associate
mesh term: Learning Disabilities
sharing ipd: No
ipd description: This is a monocentric study. All individual participant data that allow subject identification will be kept confidential.