<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/NCT04430309</url>
  </required_header>
  <id_info>
    <org_study_id>202000817B0</org_study_id>
    <nct_id>NCT04430309</nct_id>
  </id_info>
  <brief_title>Baduanjin on Patients With Schizophrenia</brief_title>
  <official_title>The Feasibility and Efficacy of Baduanjin Exercise on Cognition and Physical Fitness Among Patients With Schizophrenia:Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Taiwan University</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>
      As an ancient, popular Chinese exercise, Baduanjin is characterized by symmetrical posture,&#xD;
      deep breathing and meditation and easy to learn. Previous studies showed immediate effect of&#xD;
      Baduanjin on cognition in patients with schizophrenia.The purpose of this study is to&#xD;
      investigate the immediate effect and chronic effect of Baduanjin exercise on physical&#xD;
      fitness, cognition and daily functions in middle-aged and older adults with schizophrenia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A single-blind, 2-arm randomized controlled trial investigating the benefits of Baduanjin&#xD;
      exercise on middle-aged and older patients with schizophrenia. A total of 48 participants&#xD;
      will be assigned to either 12 weeks of 60-minute two sessions per week Baduanjin exercise&#xD;
      group or a brisk walking group. Primary outcomes are physical fitness and cognition&#xD;
      functions. Secondary outcomes are dual task performance and daily functions. Evaluation will&#xD;
      be completed at baseline, immediately after treatment and 4-week follow up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 10, 2021</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2022</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change scores of 6-minute walk test</measure>
    <time_frame>Baseline, immediate after treatment, 4-week follow up</time_frame>
    <description>This test evaluates cardiovascular fitness and walking speed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change scores of 30-second chair stand test</measure>
    <time_frame>Baseline, immediate after treatment, 4-week follow up</time_frame>
    <description>This test evaluates muscular endurance of lower-extremities.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change scores of Timed up-and-go test</measure>
    <time_frame>Baseline, immediate after treatment, 4-week follow up</time_frame>
    <description>This test evaluates functional mobility, agility and balance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change scores of Montreal cognitive assessment</measure>
    <time_frame>Baseline, immediate after treatment, 4-week follow up</time_frame>
    <description>This test evaluates global cognition.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change scores of Trail making test (part A and part B)</measure>
    <time_frame>Baseline, immediate after treatment, 4-week follow up</time_frame>
    <description>This test evaluates speed of processing, visual attention and cognitive flexibility.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change scores of Logical Memory</measure>
    <time_frame>Baseline, immediate after treatment, 4-week follow up</time_frame>
    <description>It is a subtest of the Wechsler Memory Scale. This test evaluates memory.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change scores of dual task Timed up-and-go test (manual)</measure>
    <time_frame>Baseline, immediate after treatment, 4-week follow up</time_frame>
    <description>This test requires carry a cup of water 3 cm from the top of the cup while performing the Timed up-and-go test. It evaluates dual task performance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of dual task Timed up-and-go test (cognitive)</measure>
    <time_frame>Baseline, immediate after treatment, 4-week follow up</time_frame>
    <description>This test combine serial three counting and Timed up-and-go test simultaneously. It evaluates dual task performance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of Activities of Daily Living Rating Scale III</measure>
    <time_frame>Baseline, immediate after treatment, 4-week follow up</time_frame>
    <description>It is a self-administered, paper-and-pencil test that evaluates daily functions</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Baduanjin exercise group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group will practice Badunjin in a group which include 6-8 participants and one trained medical staff. The Baduanjin is an ancient Chinese mind-body exercise, which comprised of eight simple movements.&#xD;
The sessions will take place twice a week, 60 minutes per session for a total duration of 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group will receive brisk walking activities. The sessions will take place twice a week, 60 minutes per session for a total duration of 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Baduanjin exercise program</intervention_name>
    <description>The sessions includes 10-minute warm-up, 40-minute Baduanjin exercise and 10-minute cool down.</description>
    <arm_group_label>Baduanjin exercise group</arm_group_label>
    <other_name>Eight Silken Movements</other_name>
    <other_name>Eight Silk Weaving</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brisk walking program</intervention_name>
    <description>The sessions includes 10-minute warm-up, 40-minute brisk walking and 10-minute cool down.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Having a diagnosis of schizophrenia according to the DSM-5.&#xD;
&#xD;
          -  Independent adult aged 40 years or older in the day-care center.&#xD;
&#xD;
          -  Having a stable mental status without shift in medication and keep in same dose for at&#xD;
             least one month.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serious physical conditions that will impede participation, such as cardiovascular&#xD;
             disease, musculoskeletal disease or pulmonary system disease.&#xD;
&#xD;
          -  Visual or auditory impairment that precludes completion of assessment.&#xD;
&#xD;
          -  Acute psychosis requiring hospitalization.&#xD;
&#xD;
          -  Presence of severe withdrawal or profound cognitive disability that cause difficulties&#xD;
             in following instructions.&#xD;
&#xD;
          -  Participating in another clinical trial at the same time.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Chyi-Rong Chen, Master</last_name>
    <phone>+886-7-7317123</phone>
    <phone_ext>8755</phone_ext>
    <email>ccr776@cgmh.org.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital, Kaohsiung Medical Center</name>
      <address>
        <city>Kaohsiung</city>
        <zip>833</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chyi-Rong Chen</last_name>
      <phone>+886-7-7317123</phone>
      <phone_ext>8755</phone_ext>
      <email>ccr776@cgmh.org.tw</email>
    </contact>
    <contact_backup>
      <last_name>Yee-Wen Lee</last_name>
      <phone>+886-7-7317123</phone>
      <phone_ext>8691</phone_ext>
      <email>hikare2000@cgmh.org.tw</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>July 28, 2021</last_update_submitted>
  <last_update_submitted_qc>July 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Schizophrenia, mind body intervention ,Baduanjin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04430309
org study id: 202000817B0
nct id: NCT04430309
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
As an ancient, popular Chinese exercise, Baduanjin is characterized by symmetrical posture,
      deep breathing and meditation and easy to learn. Previous studies showed immediate effect of
      Baduanjin on cognition in patients with schizophrenia.The purpose of this study is to
      investigate the immediate effect and chronic effect of Baduanjin exercise on physical
      fitness, cognition and daily functions in middle-aged and older adults with schizophrenia.
A single-blind, 2-arm randomized controlled trial investigating the benefits of Baduanjin
      exercise on middle-aged and older patients with schizophrenia. A total of 48 participants
      will be assigned to either 12 weeks of 60-minute two sessions per week Baduanjin exercise
      group or a brisk walking group. Primary outcomes are physical fitness and cognition
      functions. Secondary outcomes are dual task performance and daily functions. Evaluation will
      be completed at baseline, immediately after treatment and 4-week follow up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Change scores of 6-minute walk test
time frame: Baseline, immediate after treatment, 4-week follow up
description: This test evaluates cardiovascular fitness and walking speed.
measure: Change scores of 30-second chair stand test
time frame: Baseline, immediate after treatment, 4-week follow up
description: This test evaluates muscular endurance of lower-extremities.
measure: Change scores of Timed up-and-go test
time frame: Baseline, immediate after treatment, 4-week follow up
description: This test evaluates functional mobility, agility and balance
measure: Change scores of Montreal cognitive assessment
time frame: Baseline, immediate after treatment, 4-week follow up
description: This test evaluates global cognition.
measure: Change scores of Trail making test (part A and part B)
time frame: Baseline, immediate after treatment, 4-week follow up
description: This test evaluates speed of processing, visual attention and cognitive flexibility.
measure: Change scores of Logical Memory
time frame: Baseline, immediate after treatment, 4-week follow up
description: It is a subtest of the Wechsler Memory Scale. This test evaluates memory.
measure: Change scores of dual task Timed up-and-go test (manual)
time frame: Baseline, immediate after treatment, 4-week follow up
description: This test requires carry a cup of water 3 cm from the top of the cup while performing the Timed up-and-go test. It evaluates dual task performance.
measure: Change scores of dual task Timed up-and-go test (cognitive)
time frame: Baseline, immediate after treatment, 4-week follow up
description: This test combine serial three counting and Timed up-and-go test simultaneously. It evaluates dual task performance.
measure: Change scores of Activities of Daily Living Rating Scale III
time frame: Baseline, immediate after treatment, 4-week follow up
description: It is a self-administered, paper-and-pencil test that evaluates daily functions
arm group label: Baduanjin exercise group
arm group type: Experimental
description: The intervention group will practice Badunjin in a group which include 6-8 participants and one trained medical staff. The Baduanjin is an ancient Chinese mind-body exercise, which comprised of eight simple movements.
The sessions will take place twice a week, 60 minutes per session for a total duration of 12 weeks
arm group label: Control group
arm group type: Active Comparator
description: The control group will receive brisk walking activities. The sessions will take place twice a week, 60 minutes per session for a total duration of 12 weeks
intervention type: Behavioral
intervention name: Baduanjin exercise program
description: The sessions includes 10-minute warm-up, 40-minute Baduanjin exercise and 10-minute cool down.
arm group label: Baduanjin exercise group
other name: Eight Silken Movements
other name: Eight Silk Weaving
intervention type: Behavioral
intervention name: Brisk walking program
description: The sessions includes 10-minute warm-up, 40-minute brisk walking and 10-minute cool down.
arm group label: Control group
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Chyi-Rong Chen, Master
phone: +886-7-7317123
phone ext: 8755
email: ccr776@cgmh.org.tw
facility: 
status: Recruiting
contact: 
contact backup: 
country: Taiwan
responsible party type: Sponsor
mesh term: Schizophrenia
sharing ipd: Undecided