<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/NCT02999464</url>
  </required_header>
  <id_info>
    <org_study_id>HSEARS20151013001</org_study_id>
    <nct_id>NCT02999464</nct_id>
  </id_info>
  <brief_title>Effect of Qigong on Balance, Fall Efficacy, Wellbeing of People With Stroke in Hong Kong</brief_title>
  <official_title>Effect of Qigong on Balance, Fall Efficacy, Physical Functions and Psychological Wellbeing of People With Stroke in Hong Kong: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hong Kong Polytechnic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hong Kong Polytechnic University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the effects of qigong practice with fitness exercise&#xD;
      on balance, fall-efficacy, physical functions, psychological wellbeing and quality of life of&#xD;
      stroke survivors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants: A total of 58 stroke survivors 3 months after the current stroke will be&#xD;
      recruited.&#xD;
&#xD;
      Methodology: An assessor-blinded, randomized controlled trial will be conducted. Stroke&#xD;
      survivors will be included in the study if they meet the inclusion criteria. Selected&#xD;
      patients will be randomly allocated into either the experimental group or the control group.&#xD;
      Participants allocated in the experimental group will receive qigong training while this&#xD;
      qigong training will be replaced by a home fitness exercise in the control group. The&#xD;
      experimental and control groups will be required to practice a total of 50 minutes of qigong&#xD;
      and fitness training 3 times per week and for 16 weeks respectively. The main outcome measure&#xD;
      is balance capacity with Mini-BESTest. The secondary outcomes are fall efficacy, number of&#xD;
      falls, postural stability and control, depression, physical functions and quality of life.&#xD;
      Assessments will be done at baseline, 8 weeks and 16 weeks follow-ups by blinded assessors.&#xD;
&#xD;
      Data analysis: The results will be analyzed using two-way repeated measures analysis of&#xD;
      variance with Statistical Package for Social Science version 21.0. Alpha will be set at 0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2016</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">June 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mini-BESTest.</measure>
    <time_frame>Baseline, 8th week and 16th week after intervention</time_frame>
    <description>Change from baseline balance capacity at 8 weeks and 16 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fall Efficacy Scale - International</measure>
    <time_frame>Baseline, 8th week and 16th week after intervention</time_frame>
    <description>Change from baseline fall efficacy of the subject at 8 weeks and 16 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of falls</measure>
    <time_frame>Baseline, 8th week and 16th week after intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Limit of Stability by using Balance Master</measure>
    <time_frame>Baseline, 8th week and 16th week after intervention</time_frame>
    <description>Change from baseline postural stability at 8 weeks and 16 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geriatric Depression Scale</measure>
    <time_frame>Baseline, 8th week and 16th week after intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Five Times Sit to Stand Test</measure>
    <time_frame>Baseline, 8th week and 16th week after intervention</time_frame>
    <description>Lower extremity strength</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed Up and Go Test</measure>
    <time_frame>Baseline, 8th week and 16th week after intervention</time_frame>
    <description>Change from baseline gait speed at 8 weeks and 16 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Barthel Index</measure>
    <time_frame>Baseline, 8th week and 16th week after intervention</time_frame>
    <description>Activities of daily living function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke-Specific Quality of Life Scale</measure>
    <time_frame>Baseline, 8th week and 16th week after intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensory Organization Test by using Balance Master</measure>
    <time_frame>Baseline, 8th week and 16th week after intervention</time_frame>
    <description>Change from baseline postural control at 8 weeks and 16 weeks</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">58</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Qigong</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental group will receive a total of 50 minutes of qigong training 3 times per week and for 16 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fitness Exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fitness exercise group will receive home fitness exercise 3 times per week and for 16 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Qigong</intervention_name>
    <description>The experimental group will be required to practice a total of 50 minutes of qigong training 3 times per week and for 16 weeks</description>
    <arm_group_label>Qigong</arm_group_label>
    <other_name>body-mind exercise</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fitness exercise</intervention_name>
    <description>Active control group will be required to practice a total of 50 minutes of fitness training 3 times per week and for 16 weeks</description>
    <arm_group_label>Fitness Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of stroke and 3 months after the onset&#xD;
&#xD;
          -  First episode of stroke or recurrent of stroke&#xD;
&#xD;
          -  Able to stand for more than 15 minutes&#xD;
&#xD;
          -  Able to take anterioposterior and lateral step without assistance or aid&#xD;
&#xD;
          -  Medically stable&#xD;
&#xD;
          -  Sufficient cognition to follow commands Abbreviated Mental Test (AMT) score ≥7&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Vital signs unstable&#xD;
&#xD;
          -  History or evidence of other neurological deficits other than stroke such as multiple&#xD;
             sclerosis&#xD;
&#xD;
          -  Severe primary diseases of the cardiovascular system, liver, kidney or hematopoietic&#xD;
             system&#xD;
&#xD;
          -  Experience in qigong practice&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yiu-chung PANG, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hong Kong Polytechnic University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shuk-man YUEN, MPhil</last_name>
    <phone>852-9736-3529</phone>
    <email>mandyyuensm@yahoo.com.hk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yiu-chung PANG, PhD</last_name>
    <phone>852-2766-7156</phone>
    <email>Marco.Pang@polyu.edu.hk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kowloon Hospital</name>
      <address>
        <city>Hong Kong</city>
        <state>China</state>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shuk Man Yuen</last_name>
      <phone>852-3129-7140</phone>
      <email>mandyyuensm@yahoo.com.hk</email>
    </contact>
    <contact_backup>
      <last_name>Tracy Chen</last_name>
      <phone>852-3129-7140</phone>
    </contact_backup>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>April 24, 2016</study_first_submitted>
  <study_first_submitted_qc>December 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>January 15, 2017</last_update_submitted>
  <last_update_submitted_qc>January 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hong Kong Polytechnic University</investigator_affiliation>
    <investigator_full_name>Yuen Shuk Man</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>qigong</keyword>
  <keyword>randomized controlled trial</keyword>
  <keyword>body-mind exercise</keyword>
  <keyword>balance</keyword>
  <keyword>quality of life</keyword>
  <keyword>wellbeing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT02999464
org study id: HSEARS20151013001
nct id: NCT02999464
lead sponsor: 
has dmc: No
The purpose of this study is to compare the effects of qigong practice with fitness exercise
      on balance, fall-efficacy, physical functions, psychological wellbeing and quality of life of
      stroke survivors.
Participants: A total of 58 stroke survivors 3 months after the current stroke will be
      recruited.

      Methodology: An assessor-blinded, randomized controlled trial will be conducted. Stroke
      survivors will be included in the study if they meet the inclusion criteria. Selected
      patients will be randomly allocated into either the experimental group or the control group.
      Participants allocated in the experimental group will receive qigong training while this
      qigong training will be replaced by a home fitness exercise in the control group. The
      experimental and control groups will be required to practice a total of 50 minutes of qigong
      and fitness training 3 times per week and for 16 weeks respectively. The main outcome measure
      is balance capacity with Mini-BESTest. The secondary outcomes are fall efficacy, number of
      falls, postural stability and control, depression, physical functions and quality of life.
      Assessments will be done at baseline, 8 weeks and 16 weeks follow-ups by blinded assessors.

      Data analysis: The results will be analyzed using two-way repeated measures analysis of
      variance with Statistical Package for Social Science version 21.0. Alpha will be set at 0.05.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Mini-BESTest.
time frame: Baseline, 8th week and 16th week after intervention
description: Change from baseline balance capacity at 8 weeks and 16 weeks
measure: Fall Efficacy Scale - International
time frame: Baseline, 8th week and 16th week after intervention
description: Change from baseline fall efficacy of the subject at 8 weeks and 16 weeks
measure: Number of falls
time frame: Baseline, 8th week and 16th week after intervention
measure: Limit of Stability by using Balance Master
time frame: Baseline, 8th week and 16th week after intervention
description: Change from baseline postural stability at 8 weeks and 16 weeks
measure: Geriatric Depression Scale
time frame: Baseline, 8th week and 16th week after intervention
measure: Five Times Sit to Stand Test
time frame: Baseline, 8th week and 16th week after intervention
description: Lower extremity strength
measure: Timed Up and Go Test
time frame: Baseline, 8th week and 16th week after intervention
description: Change from baseline gait speed at 8 weeks and 16 weeks
measure: Modified Barthel Index
time frame: Baseline, 8th week and 16th week after intervention
description: Activities of daily living function
measure: Stroke-Specific Quality of Life Scale
time frame: Baseline, 8th week and 16th week after intervention
measure: Sensory Organization Test by using Balance Master
time frame: Baseline, 8th week and 16th week after intervention
description: Change from baseline postural control at 8 weeks and 16 weeks
arm group label: Qigong
arm group type: Experimental
description: Experimental group will receive a total of 50 minutes of qigong training 3 times per week and for 16 weeks.
arm group label: Fitness Exercise
arm group type: Active Comparator
description: Fitness exercise group will receive home fitness exercise 3 times per week and for 16 weeks.
intervention type: Other
intervention name: Qigong
description: The experimental group will be required to practice a total of 50 minutes of qigong training 3 times per week and for 16 weeks
arm group label: Qigong
other name: body-mind exercise
intervention type: Other
intervention name: Fitness exercise
description: Active control group will be required to practice a total of 50 minutes of fitness training 3 times per week and for 16 weeks
arm group label: Fitness Exercise
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Yiu-chung PANG, PhD
role: Principal Investigator
affiliation: The Hong Kong Polytechnic University
last name: Shuk-man YUEN, MPhil
phone: 852-9736-3529
email: mandyyuensm@yahoo.com.hk
last name: Yiu-chung PANG, PhD
phone: 852-2766-7156
email: Marco.Pang@polyu.edu.hk
facility: 
status: Recruiting
contact: 
contact backup: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: The Hong Kong Polytechnic University
investigator full name: Yuen Shuk Man
investigator title: Principal investigator
mesh term: Stroke
sharing ipd: Undecided