<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/NCT03261817</url>
  </required_header>
  <id_info>
    <org_study_id>2016-A00930-51</org_study_id>
    <nct_id>NCT03261817</nct_id>
  </id_info>
  <brief_title>A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders</brief_title>
  <acronym>PEPSYV@SI</acronym>
  <official_title>Clinical and Brain Effects of Remote Web-based Adapted Physical Activity (e-APA) in Patients With Psychotic Disorders and Healthy Subjects: A Controlled, Multicenter Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Caen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre Hospitalier du Rouvray</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Caen</source>
  <oversight_info>
    <has_dmc>Yes</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>
      In this study, an APA program by web (e-APA) will be offered to two groups of participants&#xD;
      (21 patients and 21 healthy volunteers (HV)) in remote video (use of the SAPATIC (Santé&#xD;
      Activités Physiques Adaptées utilisant les Technologies de l'Information et de la&#xD;
      Communication) platform developed by the company V@SI). At the same time, two control groups,&#xD;
      a group of 21 patients and a group of 21 HV will undergo an health education program (HE)&#xD;
      through the collaborative SAPATIC health platform of V@Si and will constitute the control&#xD;
      groups. The content of the APA sessions will be administered by V@Si. This program offers&#xD;
      content aimed to improve aerobic capacity and muscular strength while relying on the&#xD;
      motivation of the participants&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main objective is to demonstrate that APA can improve cerebral plasticity in patients&#xD;
      with schizophrenic or schizoaffective disorders (SCZ), reflected by an increase in the&#xD;
      overall volume of hippocampus.&#xD;
&#xD;
      The secondary objectives will also be to assess the impact of APA on the SCZ compared to the&#xD;
      HV:&#xD;
&#xD;
        1. on other cerebral variables (changes in the different subregions of the hippocampus&#xD;
           (Cornu Ammonis (CA: CA1,CA2-3-4), subiculum and dentate gyrus), cortical thickness,&#xD;
           N-acetyl aspartate (NAA) and glutamate as well as changes in the white matter through&#xD;
           the diffusion markers (fractional anisotropy, radial diffusivity and mean diffusivity in&#xD;
           the frontomedial-hippocampal fibers) and cerebral irrigation&#xD;
&#xD;
        2. on physiological variables (neuromuscular, cardiovascular (heart rate variability) and&#xD;
           aerobic)&#xD;
&#xD;
        3. on cognitive variables by measuring working memory, episodic memory, attentional and&#xD;
           executive functions&#xD;
&#xD;
        4. on circadian rhythms (temperature, actimetry and wake-sleep cycle)&#xD;
&#xD;
        5. on the clinical status of patients (severity of symptoms, quality of life, level of&#xD;
           activity and physical abilities).&#xD;
&#xD;
        6. on biological variables (fasting glucose, triglycerides, total cholesterol, High-density&#xD;
           lipoprotein cholesterol (HDLc), Low-density lipoprotein cholesterol (LDLc)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    No financial support&#xD;
  </why_stopped>
  <start_date type="Actual">September 29, 2017</start_date>
  <completion_date type="Actual">June 22, 2021</completion_date>
  <primary_completion_date type="Actual">June 22, 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>Randomization will be centralized and will be established for SCZ; Healthy Controls (HV) will be recruited by being matched to patients on age (according to 4 categories (18-25 years, 25-35 years, 35-50 years and&gt; 50 years), gender and level of activity estimated by the self-administered questionnaire of Ricci and Gagnon.&#xD;
Randomization will be carried out in two arms:&#xD;
interventional (adapted physical activity APA)&#xD;
control (health education program)</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>hippocampal volumes</measure>
    <time_frame>at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment</time_frame>
    <description>The primary endpoint is the right and left hippocampal volumes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cerebral variables</measure>
    <time_frame>at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment</time_frame>
    <description>changes in the different subregions of the hippocampus (CA1, CA2-3-4, subiculum and dentate gyrus, cortical thickness, N-acetyl aspartate (NAA) and glutamate as well as changes in the white matter through the diffusion markers (fractional anisotropy, radial diffusivity and mean diffusivity in the frontomedial-hippocampal fibers) and cerebral irrigation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physiological variables</measure>
    <time_frame>at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment</time_frame>
    <description>neuromuscular, cardiovascular (heart rate variability) and aerobic (VO2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circadian rhythms</measure>
    <time_frame>at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment</time_frame>
    <description>temperature, actimetry and wake-sleep cycle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical status</measure>
    <time_frame>at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment</time_frame>
    <description>severity of symptoms, quality of life, level of activity and physical abilities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biological variables</measure>
    <time_frame>at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment</time_frame>
    <description>fasting glucose, triglycerides, total cholesterol, HDLc, LDLc</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Physical Activity</condition>
  <condition>Schizo Affective Disorder</condition>
  <arm_group>
    <arm_group_label>APA in patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients receiving physical activity (APA) by web during 16 weeks with 2 sessions a week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HE in patients</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>patients receiving Health education program (HE) by web during 16 weeks with 2 sessions a week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>APA in healthy volunteer controls</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Healthy volunteers receiving physical activity (APA) by web during 16 weeks with 2 sessions a week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HE in healthy volunteer controls</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Healthy volunteers receiving Health education program (HE) by web during 16 weeks with 2 sessions a week</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical activity (APA)</intervention_name>
    <description>2 sessions a week of 1 hour during 16 weeks. APA exercises by web will be aerobic type associated with muscle toning program; Activities will combine relaxation techniques, body expression and muscle relaxation (yoga, stretching, relaxation, step etc ...).&#xD;
The intensity of the activities will be individualized for each participant according to his/her physical condition</description>
    <arm_group_label>APA in healthy volunteer controls</arm_group_label>
    <arm_group_label>APA in patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health Education program (HE)</intervention_name>
    <description>2 sessions a week of 1 hour during 16 weeks HE by web will be delivered and was composed of information on the main mental disorders, the benefits of physical activity, healthy lifestyle (dietary balance, sleep cycle, stress management), alcohol, drug, tobacco and cardiovascular risk factors</description>
    <arm_group_label>HE in healthy volunteer controls</arm_group_label>
    <arm_group_label>HE in patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients:&#xD;
&#xD;
          -  Be over 18 years of age and under 60 years of age&#xD;
&#xD;
          -  with schizophrenia or schizoaffective disorder according to DSM-IV (Diagnostic and&#xD;
             Statistical Manual of Mental Disorders, 4th edition) criteria established with a&#xD;
             semi-structured interview (Mini International Neuropsychiatric Interview, French&#xD;
             version 5.0.0).&#xD;
&#xD;
          -  The possibility of receiving each of the 2 interventions (APA or HE)&#xD;
&#xD;
          -  No change in psychotropic drugs (antidepressants, antipsychotics or mood regulators)&#xD;
             during the 2 months prior to inclusion for patients.&#xD;
&#xD;
          -  Collecting the signature of informed consent.&#xD;
&#xD;
          -  The need to be affiliated to a medical welfare&#xD;
&#xD;
          -  The agreement of the guardian or trustee in case of a protected major&#xD;
&#xD;
        Healthy Volunteers:&#xD;
&#xD;
          -  between 18 and 60 years old&#xD;
&#xD;
          -  The possibility of receiving each of the 2 interventions (APA or HE)&#xD;
&#xD;
          -  Collecting the signature of informed consent.&#xD;
&#xD;
          -  The need to be affiliated to a medical welfare&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients with only one of the non-inclusion criteria may not be eligible to participate in&#xD;
        the research. These criteria are:&#xD;
&#xD;
          -  Age under 18 or over 60 years old&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  The inclusion of the patient in another biomedical research protocol (during the&#xD;
             present study)&#xD;
&#xD;
          -  Patients with progressive neurological disease&#xD;
&#xD;
          -  Patients with contraindications to MRI (including electronic or metal implants)&#xD;
&#xD;
          -  Patients who refused to wear earplugs during the MRI examination&#xD;
&#xD;
          -  Patients with a physical contraindication to physical activity (moderate to severe&#xD;
             heart failure, severe valvular disease, unstable coronary disease, acute pulmonary&#xD;
             embolism or untreated deep venous thrombosis, uncontrolled hypertension, pulmonary&#xD;
             arterial hypertension, treaty)&#xD;
&#xD;
          -  Neuromuscular pathologies, severe sensory and / or motor neuropathy&#xD;
&#xD;
          -  Rheumatic and articular pathologies; Rheumatologic / orthopedic problems or bone&#xD;
             lesions at risk of fracture contraindicating physical activity&#xD;
&#xD;
          -  History of stroke or myocardial infarction less than 6 months old at the selection&#xD;
             visit&#xD;
&#xD;
        Healthy Volunteers&#xD;
&#xD;
        Participants with only one of the non-inclusion criteria may not be eligible to participate&#xD;
        in the research. These criteria are:&#xD;
&#xD;
          -  Age under 18 or over 60 years old&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Inclusion of the participant in another biomedical research protocol (during this&#xD;
             study)&#xD;
&#xD;
          -  Participants with progressive neurological disease&#xD;
&#xD;
          -  Participants with a contraindication to MRI (including electronic or metal implants)&#xD;
&#xD;
          -  Participants refused to wear ear plugs during the MRI examination&#xD;
&#xD;
          -  Participants with life-long schizophrenia or schizoaffective disorder according to the&#xD;
             DSM-IV criteria established with a semi-structured interview (Mini International&#xD;
             Neuropsychiatric Interview, MINI; French version 5.0.0).&#xD;
&#xD;
          -  Presence of cardiovascular pathologies contraindicating physical activity (moderate to&#xD;
             severe heart failure, severe valvular disease, unstable coronary disease, acute&#xD;
             pulmonary embolism or untreated deep venous thrombosis, uncontrolled hypertension,&#xD;
             pulmonary arterial hypertension, rhythm disorder untreated)&#xD;
&#xD;
          -  Neuromuscular pathologies, severe sensory and / or motor neuropathy&#xD;
&#xD;
          -  Rheumatic and articular diseases, rheumatological / orthopedic problems or fracture&#xD;
             risk bone lesions&#xD;
&#xD;
          -  History of stroke or myocardial infarction less than 6 months old at the selection&#xD;
             visit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Caen University Hospital</name>
      <address>
        <city>Caen</city>
        <zip>14033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>March 8, 2022</last_update_submitted>
  <last_update_submitted_qc>March 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>web</keyword>
  <keyword>brain imaging</keyword>
  <keyword>heart rate variability</keyword>
  <keyword>circadian cycles</keyword>
  <keyword>cognition</keyword>
  <keyword>well-being</keyword>
  <keyword>hippocampus</keyword>
  <keyword>N acetyl aspartate</keyword>
  <keyword>white matter</keyword>
  <keyword>physical activity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
    <mesh_term>Mood Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03261817
org study id: 2016-A00930-51
nct id: NCT03261817
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this study, an APA program by web (e-APA) will be offered to two groups of participants
      (21 patients and 21 healthy volunteers (HV)) in remote video (use of the SAPATIC (Santé
      Activités Physiques Adaptées utilisant les Technologies de l'Information et de la
      Communication) platform developed by the company V@SI). At the same time, two control groups,
      a group of 21 patients and a group of 21 HV will undergo an health education program (HE)
      through the collaborative SAPATIC health platform of V@Si and will constitute the control
      groups. The content of the APA sessions will be administered by V@Si. This program offers
      content aimed to improve aerobic capacity and muscular strength while relying on the
      motivation of the participants
The main objective is to demonstrate that APA can improve cerebral plasticity in patients
      with schizophrenic or schizoaffective disorders (SCZ), reflected by an increase in the
      overall volume of hippocampus.

      The secondary objectives will also be to assess the impact of APA on the SCZ compared to the
      HV:

        1. on other cerebral variables (changes in the different subregions of the hippocampus
           (Cornu Ammonis (CA: CA1,CA2-3-4), subiculum and dentate gyrus), cortical thickness,
           N-acetyl aspartate (NAA) and glutamate as well as changes in the white matter through
           the diffusion markers (fractional anisotropy, radial diffusivity and mean diffusivity in
           the frontomedial-hippocampal fibers) and cerebral irrigation

        2. on physiological variables (neuromuscular, cardiovascular (heart rate variability) and
           aerobic)

        3. on cognitive variables by measuring working memory, episodic memory, attentional and
           executive functions

        4. on circadian rhythms (temperature, actimetry and wake-sleep cycle)

        5. on the clinical status of patients (severity of symptoms, quality of life, level of
           activity and physical abilities).

        6. on biological variables (fasting glucose, triglycerides, total cholesterol, High-density
           lipoprotein cholesterol (HDLc), Low-density lipoprotein cholesterol (LDLc)
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomization will be centralized and will be established for SCZ; Healthy Controls (HV) will be recruited by being matched to patients on age (according to 4 categories (18-25 years, 25-35 years, 35-50 years and> 50 years), gender and level of activity estimated by the self-administered questionnaire of Ricci and Gagnon.
Randomization will be carried out in two arms:
interventional (adapted physical activity APA)
control (health education program)
primary purpose: Supportive Care
masking: None (Open Label)
measure: hippocampal volumes
time frame: at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment
description: The primary endpoint is the right and left hippocampal volumes
measure: Cerebral variables
time frame: at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment
description: changes in the different subregions of the hippocampus (CA1, CA2-3-4, subiculum and dentate gyrus, cortical thickness, N-acetyl aspartate (NAA) and glutamate as well as changes in the white matter through the diffusion markers (fractional anisotropy, radial diffusivity and mean diffusivity in the frontomedial-hippocampal fibers) and cerebral irrigation
measure: Physiological variables
time frame: at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment
description: neuromuscular, cardiovascular (heart rate variability) and aerobic (VO2)
measure: Circadian rhythms
time frame: at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment
description: temperature, actimetry and wake-sleep cycle
measure: Clinical status
time frame: at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment
description: severity of symptoms, quality of life, level of activity and physical abilities
measure: Biological variables
time frame: at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment
description: fasting glucose, triglycerides, total cholesterol, HDLc, LDLc
arm group label: APA in patients
arm group type: Experimental
description: patients receiving physical activity (APA) by web during 16 weeks with 2 sessions a week
arm group label: HE in patients
arm group type: Sham Comparator
description: patients receiving Health education program (HE) by web during 16 weeks with 2 sessions a week
arm group label: APA in healthy volunteer controls
arm group type: Active Comparator
description: Healthy volunteers receiving physical activity (APA) by web during 16 weeks with 2 sessions a week
arm group label: HE in healthy volunteer controls
arm group type: Sham Comparator
description: Healthy volunteers receiving Health education program (HE) by web during 16 weeks with 2 sessions a week
intervention type: Behavioral
intervention name: Physical activity (APA)
description: 2 sessions a week of 1 hour during 16 weeks. APA exercises by web will be aerobic type associated with muscle toning program; Activities will combine relaxation techniques, body expression and muscle relaxation (yoga, stretching, relaxation, step etc ...).
The intensity of the activities will be individualized for each participant according to his/her physical condition
arm group label: APA in healthy volunteer controls
arm group label: APA in patients
intervention type: Behavioral
intervention name: Health Education program (HE)
description: 2 sessions a week of 1 hour during 16 weeks HE by web will be delivered and was composed of information on the main mental disorders, the benefits of physical activity, healthy lifestyle (dietary balance, sleep cycle, stress management), alcohol, drug, tobacco and cardiovascular risk factors
arm group label: HE in healthy volunteer controls
arm group label: HE in patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Mental Disorders
mesh term: Psychotic Disorders
mesh term: Mood Disorders
sharing ipd: No