<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/NCT02258269</url>
  </required_header>
  <id_info>
    <org_study_id>SDRA00201401</org_study_id>
    <nct_id>NCT02258269</nct_id>
  </id_info>
  <brief_title>The Effect of Square Dance on Rheumatoid Arthritis</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chengdu PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chengdu PLA General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to observe the effect of square dance on rheumatoid arthritis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes from baseline Arthritis Helplessness Index (AHI) at 24 weeks</measure>
    <time_frame>At 0 week, 12 weeks, 24 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>SQ</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with rheumatoid arthritis exercise square dance</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients with rheumatoid arthritis listen to accompany music of square dance at home</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SQ</intervention_name>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>SQ</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>SQ</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  had wrist and/or MCP involvement&#xD;
&#xD;
          -  aged 18 years diagnosed by rheumatology consultants with RA&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe psychological difficulties&#xD;
&#xD;
          -  currently receiving mental health care&#xD;
&#xD;
          -  any medical condition that might prevent them from safely exercising (e.g. history of&#xD;
             more severe heart, lung or cerebrovascular disease)&#xD;
&#xD;
          -  previously attended an education programme&#xD;
&#xD;
          -  had a Modified Health Assessment Questionnaire score above 2 (0-3)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>General Hospital of Chengdu Military Area Command PLA</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610083</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>October 3, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>March 31, 2017</last_update_submitted>
  <last_update_submitted_qc>March 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chengdu PLA General Hospital</investigator_affiliation>
    <investigator_full_name>Yang Min</investigator_full_name>
    <investigator_title>Ph.D</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <!-- 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/NCT02258269
org study id: SDRA00201401
nct id: NCT02258269
lead sponsor: 
has dmc: Yes
The purpose of this study is to observe the effect of square dance on rheumatoid arthritis.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Changes from baseline Arthritis Helplessness Index (AHI) at 24 weeks
time frame: At 0 week, 12 weeks, 24 weeks
arm group label: SQ
arm group type: Experimental
description: Patients with rheumatoid arthritis exercise square dance
arm group label: Control
arm group type: Sham Comparator
description: Patients with rheumatoid arthritis listen to accompany music of square dance at home
intervention type: Other
intervention name: SQ
arm group label: Control
arm group label: SQ
intervention type: Other
intervention name: Control
arm group label: Control
arm group label: SQ
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chengdu PLA General Hospital
investigator full name: Yang Min
investigator title: Ph.D
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid