<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/NCT04411979</url>
  </required_header>
  <id_info>
    <org_study_id>MOST 107-2635-B-182A-002</org_study_id>
    <secondary_id>201702283A3C601</secondary_id>
    <nct_id>NCT04411979</nct_id>
  </id_info>
  <brief_title>Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia</brief_title>
  <official_title>Cognitive Function and Energy Metabolites in Schizophrenia: the Effect of Wearable Device-assisted Walking</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Science and Technology, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chang Gung Memorial Hospital</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>
      This study is a 12-week randomized-controlled clinical trial. It will be planned to conduct&#xD;
      in a total of 120 male and female subjects from the Department of Psychiatry at Kaohsiung&#xD;
      Chang Gung Memorial Hospital. Eligible subjects will be psychiatric patients, aged between&#xD;
      20-65 years old, who have psychiatric diagnosis of schizophrenia and fulfill the inclusion&#xD;
      and exclusion criteria. The intervention with aerobic walking programs will be initiated&#xD;
      after randomization for patients who continue their usual treatment. Subjects will be&#xD;
      enrolled for 12 weeks aerobic walking treatment and randomly assigned to (1)&#xD;
      treatment-as-usual, (2) treatment-as-usual plus aerobic walking. We will measure the&#xD;
      treatment response to clarify the effect of aerobic walking in patients with schizophrenia.&#xD;
      This study is being performed to investigate the possibly beneficial effects of aerobic&#xD;
      walking on cognitive function and energy metabolites in schizophrenia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This 12-week randomized-controlled clinical trial will be planned to conduct in a total of&#xD;
      120 male and female subjects from the Department of Psychiatry at Kaohsiung Chang Gung&#xD;
      Memorial Hospital. Eligible subjects will be psychiatric patients, aged between 20-65 years&#xD;
      old, who have psychiatric diagnosis of schizophrenia and fulfill the inclusion and exclusion&#xD;
      criteria. The intervention with aerobic walking programs will be initiated after&#xD;
      randomization for patients who continue their usual treatment. Subjects will be enrolled for&#xD;
      12 weeks aerobic walking treatment and randomly assigned to (1) treatment-as-usual, (2)&#xD;
      treatment-as-usual plus aerobic walking. The wearable watch will be used during the&#xD;
      participants join the walking programs. We will measure the treatment response to investigate&#xD;
      the effect of aerobic walking in patients with schizophrenia. This study is being performed&#xD;
      to investigate the possibly beneficial effects of aerobic walking on cognitive function in&#xD;
      schizophrenia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 27, 2018</start_date>
  <completion_date type="Actual">October 15, 2019</completion_date>
  <primary_completion_date type="Actual">July 17, 2019</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cognitive function change</measure>
    <time_frame>week 12</time_frame>
    <description>cognitive function change assessed by Brief Assessment of Cognition in Schizophrenia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>treatment change assessed by serum levels of energy metabolites (e.g., β-hydroxybutyrate)</measure>
    <time_frame>week 12</time_frame>
    <description>change assessment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>treatment change assessed by the Positive and Negative Syndrome Scale</measure>
    <time_frame>week 12</time_frame>
    <description>minimum value 30, maximum value 210; higher scores mean a worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>treatment change assessed by peripheral blood metabolic profiles (e.g., plasma cholesterol level)</measure>
    <time_frame>week 12</time_frame>
    <description>change assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>treatment change assessed by metabolic profiles (e.g., body weight in kilograms)</measure>
    <time_frame>week 6, week 12</time_frame>
    <description>change assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>treatment change assessed by serum levels of inflammatory cytokines (e.g., IL-8)</measure>
    <time_frame>week 12</time_frame>
    <description>change assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>treatment change assessed by 6-minute walk test</measure>
    <time_frame>week 12</time_frame>
    <description>change assessment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>treatment-as-usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>treatment-as-usual plus aerobic walking</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>treatment-as-usual plus aerobic walking</intervention_name>
    <description>aerobic walking</description>
    <arm_group_label>treatment-as-usual plus aerobic walking</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The patient has been diagnosed of schizophrenia according to the Diagnostic and&#xD;
             Statistical Manual of Mental Disorders, fifth edition criteria (DSM-5) criteria&#xD;
&#xD;
          2. The patient has the ability to complete the written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The patient has been diagnosed with organic mental disorders, intelligence disability,&#xD;
             dementia, major depressive disorder, bipolar affective disorder, and alcohol or&#xD;
             substance use disorder&#xD;
&#xD;
          2. The patient has major systemic physical diseases, including cardiovascular diseases,&#xD;
             uncontrollable arrhythmia, renal diseases, liver diseases or thyroid diseases&#xD;
&#xD;
          3. The patient has certified as physical disability&#xD;
&#xD;
          4. The patient is pregnant or has genetic diseases or infectious conditions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yu-Chi Huang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</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/NCT04411979
org study id: MOST 107-2635-B-182A-002
secondary id: 201702283A3C601
nct id: NCT04411979
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a 12-week randomized-controlled clinical trial. It will be planned to conduct
      in a total of 120 male and female subjects from the Department of Psychiatry at Kaohsiung
      Chang Gung Memorial Hospital. Eligible subjects will be psychiatric patients, aged between
      20-65 years old, who have psychiatric diagnosis of schizophrenia and fulfill the inclusion
      and exclusion criteria. The intervention with aerobic walking programs will be initiated
      after randomization for patients who continue their usual treatment. Subjects will be
      enrolled for 12 weeks aerobic walking treatment and randomly assigned to (1)
      treatment-as-usual, (2) treatment-as-usual plus aerobic walking. We will measure the
      treatment response to clarify the effect of aerobic walking in patients with schizophrenia.
      This study is being performed to investigate the possibly beneficial effects of aerobic
      walking on cognitive function and energy metabolites in schizophrenia.
This 12-week randomized-controlled clinical trial will be planned to conduct in a total of
      120 male and female subjects from the Department of Psychiatry at Kaohsiung Chang Gung
      Memorial Hospital. Eligible subjects will be psychiatric patients, aged between 20-65 years
      old, who have psychiatric diagnosis of schizophrenia and fulfill the inclusion and exclusion
      criteria. The intervention with aerobic walking programs will be initiated after
      randomization for patients who continue their usual treatment. Subjects will be enrolled for
      12 weeks aerobic walking treatment and randomly assigned to (1) treatment-as-usual, (2)
      treatment-as-usual plus aerobic walking. The wearable watch will be used during the
      participants join the walking programs. We will measure the treatment response to investigate
      the effect of aerobic walking in patients with schizophrenia. This study is being performed
      to investigate the possibly beneficial effects of aerobic walking on cognitive function in
      schizophrenia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: cognitive function change
time frame: week 12
description: cognitive function change assessed by Brief Assessment of Cognition in Schizophrenia
measure: treatment change assessed by serum levels of energy metabolites (e.g., β-hydroxybutyrate)
time frame: week 12
description: change assessment
measure: treatment change assessed by the Positive and Negative Syndrome Scale
time frame: week 12
description: minimum value 30, maximum value 210; higher scores mean a worse outcome
measure: treatment change assessed by peripheral blood metabolic profiles (e.g., plasma cholesterol level)
time frame: week 12
description: change assessment
measure: treatment change assessed by metabolic profiles (e.g., body weight in kilograms)
time frame: week 6, week 12
description: change assessment
measure: treatment change assessed by serum levels of inflammatory cytokines (e.g., IL-8)
time frame: week 12
description: change assessment
measure: treatment change assessed by 6-minute walk test
time frame: week 12
description: change assessment
arm group label: treatment-as-usual
arm group type: No Intervention
arm group label: treatment-as-usual plus aerobic walking
arm group type: Experimental
intervention type: Other
intervention name: treatment-as-usual plus aerobic walking
description: aerobic walking
arm group label: treatment-as-usual plus aerobic walking
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Yu-Chi Huang, MD
role: Principal Investigator
affiliation: Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Schizophrenia
sharing ipd: No