<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/NCT03800368</url>
  </required_header>
  <id_info>
    <org_study_id>HKU_Psych</org_study_id>
    <nct_id>NCT03800368</nct_id>
  </id_info>
  <brief_title>Exercise and Overnight Motor Sequence Task</brief_title>
  <acronym>EOMST</acronym>
  <official_title>12-week Aerobic-Anaerobic Transition Exercise Intervention and Overnight Sleep-dependent Procedural Memory Consolidation in Patients With Schizophrenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</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>
      The objective of this randomized controlled trial (RCT) is to compare the changes of the&#xD;
      sleep-related memory functions in patients with psychosis after they have completed the&#xD;
      12-week high-intensity exercise intervention, the 12-week low-intensity exercise&#xD;
      intervention, or the 12-week controlled non-exercise intervention respectively. Fifty-one&#xD;
      patients with psychosis, patients who received either the high-intensity exercise or&#xD;
      low-intensity exercise as intervention shown a significant improvement to their impaired&#xD;
      sleep-related memory function, while those who received non-exercise intervention has no such&#xD;
      improvement. Moreover, high-intensity exercise may have a more prominent effect compare to&#xD;
      low-intensity exercise.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 21, 2016</start_date>
  <completion_date type="Actual">September 1, 2017</completion_date>
  <primary_completion_date type="Actual">September 1, 2017</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>The sleep-dependent procedural memory consolidation after 12 weeks of intervention</measure>
    <time_frame>12-week Follow-up</time_frame>
    <description>Tested by comparing the finger-tapping motor sequence task performance between the three groups during the 12-week follow-up assessment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The verbal memory consolidation after 12 weeks of intervention</measure>
    <time_frame>12-week Follow-up</time_frame>
    <description>Tested by comparing the logical memory task performance between the three groups during the 12-week follow-up assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The attention performance after 12 weeks of intervention</measure>
    <time_frame>12-week Follow-up</time_frame>
    <description>Measured by using the cancellation task performance and compare between the three groups during the 12-week follow-up assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The sleep quality after 12 weeks of intervention</measure>
    <time_frame>12-week Follow-up</time_frame>
    <description>Measured by using the Pittsburgh Sleep Quality Index (PSQI) and compare the differences between the three groups during the 12-week follow-up assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The insomnia severity after 12 weeks of intervention</measure>
    <time_frame>12-week Follow-up</time_frame>
    <description>Measured by using the Insomnia Severity Index (ISI) and compare the differences between the three groups during the 12-week follow-up assessment</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Schizophrenia and Related Disorders</condition>
  <condition>Psychotic Disorders</condition>
  <arm_group>
    <arm_group_label>High-endurance group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group of subjects will receive 2-3 sessions of high-intensity cycling exercise training per week, for a total of 12 weeks. The exercise the subjects received will interchange between the aerobic and anaerobic state.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low-endurance group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group of subjects will receive 2-3 sessions of low-intensity cycling exercise training per week, for a total of 12 weeks. The exercise the subjects received will maintain at an aerobic level.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Psycho-education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group of subjects will receive 2-3 sessions of psycho-education class per week, for a total of 12 weeks. The content of the class includes non-exercise related psycho-education content to participants (e.g., food hygiene, psychological well being, food nutrition, etc).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>Indoor cycling exercise intervention</description>
    <arm_group_label>High-endurance group</arm_group_label>
    <arm_group_label>Low-endurance group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non-exercise</intervention_name>
    <description>Psycho-education</description>
    <arm_group_label>Psycho-education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged from 18 to 55&#xD;
&#xD;
          -  Based on the SCID diagnosed to have schizophrenia and related psychotic disorders&#xD;
&#xD;
          -  Ability to understand the nature of the study and to give written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe physical illness (Myocardial Infarction, Hypertension, Fracture, Spinal&#xD;
             problems in which exercise may be contraindicated), and seizure disorders&#xD;
&#xD;
          -  Comorbid substance dependence&#xD;
&#xD;
          -  Unstable psychotic symptoms&#xD;
&#xD;
          -  A history of brain trauma or organic brain disease&#xD;
&#xD;
          -  Known history of intellectual disability or special school attendance&#xD;
&#xD;
          -  Answered one or more &quot;yes&quot; in the PAR-Q and without doctors approval for exercise&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lik Hang Lincoln Lo</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>January 8, 2019</last_update_submitted>
  <last_update_submitted_qc>January 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Dr. Lincoln Lik-Hang Lo</investigator_full_name>
    <investigator_title>Postdoctoral Fellow</investigator_title>
  </responsible_party>
  <keyword>Exercise</keyword>
  <keyword>Sleep-dependent memory consolidation</keyword>
  <keyword>Aerobic</keyword>
  <keyword>Anaerobic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Psychotic 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/NCT03800368
org study id: HKU_Psych
nct id: NCT03800368
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this randomized controlled trial (RCT) is to compare the changes of the
      sleep-related memory functions in patients with psychosis after they have completed the
      12-week high-intensity exercise intervention, the 12-week low-intensity exercise
      intervention, or the 12-week controlled non-exercise intervention respectively. Fifty-one
      patients with psychosis, patients who received either the high-intensity exercise or
      low-intensity exercise as intervention shown a significant improvement to their impaired
      sleep-related memory function, while those who received non-exercise intervention has no such
      improvement. Moreover, high-intensity exercise may have a more prominent effect compare to
      low-intensity exercise.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The sleep-dependent procedural memory consolidation after 12 weeks of intervention
time frame: 12-week Follow-up
description: Tested by comparing the finger-tapping motor sequence task performance between the three groups during the 12-week follow-up assessment.
measure: The verbal memory consolidation after 12 weeks of intervention
time frame: 12-week Follow-up
description: Tested by comparing the logical memory task performance between the three groups during the 12-week follow-up assessment
measure: The attention performance after 12 weeks of intervention
time frame: 12-week Follow-up
description: Measured by using the cancellation task performance and compare between the three groups during the 12-week follow-up assessment
measure: The sleep quality after 12 weeks of intervention
time frame: 12-week Follow-up
description: Measured by using the Pittsburgh Sleep Quality Index (PSQI) and compare the differences between the three groups during the 12-week follow-up assessment
measure: The insomnia severity after 12 weeks of intervention
time frame: 12-week Follow-up
description: Measured by using the Insomnia Severity Index (ISI) and compare the differences between the three groups during the 12-week follow-up assessment
arm group label: High-endurance group
arm group type: Experimental
description: This group of subjects will receive 2-3 sessions of high-intensity cycling exercise training per week, for a total of 12 weeks. The exercise the subjects received will interchange between the aerobic and anaerobic state.
arm group label: Low-endurance group
arm group type: Experimental
description: This group of subjects will receive 2-3 sessions of low-intensity cycling exercise training per week, for a total of 12 weeks. The exercise the subjects received will maintain at an aerobic level.
arm group label: Psycho-education
arm group type: Active Comparator
description: This group of subjects will receive 2-3 sessions of psycho-education class per week, for a total of 12 weeks. The content of the class includes non-exercise related psycho-education content to participants (e.g., food hygiene, psychological well being, food nutrition, etc).
intervention type: Other
intervention name: Exercise
description: Indoor cycling exercise intervention
arm group label: High-endurance group
arm group label: Low-endurance group
intervention type: Other
intervention name: Non-exercise
description: Psycho-education
arm group label: Psycho-education
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Lik Hang Lincoln Lo
role: Principal Investigator
affiliation: The University of Hong Kong
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Dr. Lincoln Lik-Hang Lo
investigator title: Postdoctoral Fellow
mesh term: Schizophrenia
mesh term: Psychotic Disorders
sharing ipd: No