<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/NCT03751852</url>
  </required_header>
  <id_info>
    <org_study_id>JCWowExercise</org_study_id>
    <secondary_id>124-01</secondary_id>
    <nct_id>NCT03751852</nct_id>
  </id_info>
  <brief_title>Body-Mind-Spirit Intervention for Women With Early Psychosis</brief_title>
  <official_title>Body-Mind-Spirit Intervention for Women With Early Psychosis: a Randomized Controlled Trial</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>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>
      This is an open-labelled randomised controlled trial (RCT) that aims to examine the&#xD;
      effectiveness of exercise coaching approach in improving the physical activity engagement in&#xD;
      patients with psychosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with psychosis will be recruited from the out-patient department (OPD) of the Kwai&#xD;
      Chung Hospital (KCH). The patient with informed consent will be randomly assigned to exercise&#xD;
      coaching or psychoeducation group to prevent decline in cognitive and functional outcomes&#xD;
      known to be common in this group. This comprises locally-tested evidence-based intervention&#xD;
      strategies such as exercise and Yoga intervention, combined with exercise coaching to&#xD;
      consolidate the exercise habit. Each of the intervention includes 28 sessions spanning&#xD;
      for16-week.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">November 15, 2018</start_date>
  <completion_date type="Anticipated">September 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 30, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Physical Activity Engagement</measure>
    <time_frame>Change from baseline to 6-month post-intervention</time_frame>
    <description>Measured by the Chinese Version of International Physical Activity Questionnaire (IPAQ-C)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">57</enrollment>
  <condition>Psychosis</condition>
  <arm_group>
    <arm_group_label>Exercise coaching group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This intervention is an integration of aerobic exercise, yoga, mindfulness and exercise coaching. Exercise class and coaching will be provided weekly in the first 8 weeks. In the next 8 week, exercise class will be provided weekly while exercise coaching will be provided bi-weekly. The exercise class includes aerobic exercise coached by a well-trained intervention officer, and the yoga and mindfulness coached by a certified yoga instructor. The exercise coaching session followed by some stretching and aerobic exercise session. Both motivational coaching and aerobic exercise will be coached by a well-trained intervention officer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Psychoeducation group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group is similar with the exercise coaching group while exercise coaching session will be substituted by psychoeducation session.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise Coaching</intervention_name>
    <description>28 classes in 16 weeks</description>
    <arm_group_label>Exercise coaching group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychoeducation</intervention_name>
    <description>28 classes in 16 weeks</description>
    <arm_group_label>Psychoeducation group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Age from 18-64&#xD;
&#xD;
          -  Based on the Fifth version of the Diagnostic and Statistical Manual of Mental&#xD;
             Disorders diagnosis to have schizophrenia and related psychotic disorders&#xD;
&#xD;
          -  Have the ability to understand Chinese&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
          -  Physically fit for participating in our study assessed by using the Physical Activity&#xD;
             Readiness Questionnaire (PAR-Q)&#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;
          -  Any history of brain trauma or organic brain disease&#xD;
&#xD;
          -  Known history of intellectual disability or special school attendance&#xD;
&#xD;
          -  Other mental conditions that requires other treatment priorities, e.g., suicidal risk.&#xD;
&#xD;
          -  Other medical conditions that severely limits participation, comprehension, or&#xD;
             adherence to the treatment or assessment e.g., epilepsy, dementia, terminal medical&#xD;
             illness.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>As agreement with funder</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Yu Hai Chen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <zip>0000</zip>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>June 14, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>April 10, 2021</last_update_submitted>
  <last_update_submitted_qc>April 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2021</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>Professor Eric Y.H. Chen</investigator_full_name>
    <investigator_title>Chi-li Pao Foundation Professor of Psychiatry; Chair Professor in Psychiatry; Head, Department of Psychiatry</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psychotic Disorders</mesh_term>
    <mesh_term>Mental 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/NCT03751852
org study id: JCWowExercise
secondary id: 124-01
nct id: NCT03751852
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is an open-labelled randomised controlled trial (RCT) that aims to examine the
      effectiveness of exercise coaching approach in improving the physical activity engagement in
      patients with psychosis.
Patients with psychosis will be recruited from the out-patient department (OPD) of the Kwai
      Chung Hospital (KCH). The patient with informed consent will be randomly assigned to exercise
      coaching or psychoeducation group to prevent decline in cognitive and functional outcomes
      known to be common in this group. This comprises locally-tested evidence-based intervention
      strategies such as exercise and Yoga intervention, combined with exercise coaching to
      consolidate the exercise habit. Each of the intervention includes 28 sessions spanning
      for16-week.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Physical Activity Engagement
time frame: Change from baseline to 6-month post-intervention
description: Measured by the Chinese Version of International Physical Activity Questionnaire (IPAQ-C)
arm group label: Exercise coaching group
arm group type: Experimental
description: This intervention is an integration of aerobic exercise, yoga, mindfulness and exercise coaching. Exercise class and coaching will be provided weekly in the first 8 weeks. In the next 8 week, exercise class will be provided weekly while exercise coaching will be provided bi-weekly. The exercise class includes aerobic exercise coached by a well-trained intervention officer, and the yoga and mindfulness coached by a certified yoga instructor. The exercise coaching session followed by some stretching and aerobic exercise session. Both motivational coaching and aerobic exercise will be coached by a well-trained intervention officer.
arm group label: Psychoeducation group
arm group type: Active Comparator
description: This group is similar with the exercise coaching group while exercise coaching session will be substituted by psychoeducation session.
intervention type: Behavioral
intervention name: Exercise Coaching
description: 28 classes in 16 weeks
arm group label: Exercise coaching group
intervention type: Behavioral
intervention name: Psychoeducation
description: 28 classes in 16 weeks
arm group label: Psychoeducation group
criteria: 
gender: Female
gender based: Yes
gender description: As agreement with funder
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: Eric Yu Hai Chen, MD
role: Principal Investigator
affiliation: The University of Hong Kong
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Professor Eric Y.H. Chen
investigator title: Chi-li Pao Foundation Professor of Psychiatry; Chair Professor in Psychiatry; Head, Department of Psychiatry
mesh term: Psychotic Disorders
mesh term: Mental Disorders
sharing ipd: No