<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/NCT01681082</url>
  </required_header>
  <id_info>
    <org_study_id>SE-2012-0539</org_study_id>
    <nct_id>NCT01681082</nct_id>
  </id_info>
  <brief_title>Psychological Effects of Tai Chi Training</brief_title>
  <official_title>Psychological Effects of Tai Chi Training</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <brief_summary>
    <textblock>
      The general purpose of this study is to examine the effect of tai chi training on cognitive&#xD;
      function in young adults. The investigators will test subjects enrolled in a semester-long&#xD;
      tai chi course along with control subjects. The specific aims are to measure duration of&#xD;
      practice, cognitive function, physical balance, and Attention Deficit Hyperactivity Disorder&#xD;
      (ADHD) indicators. The investigators primary hypotheses are that, compared to controls,&#xD;
      subjects in the tai chi course will show improvements in (1a) spatial working memory and (1b)&#xD;
      response inhibition. The investigators secondary hypotheses are that, among the subjects&#xD;
      participating in the tai chi course, these cognitive improvements will correlate with (2a)&#xD;
      improvements in balance and (2b) duration of tai chi practice, and that, among all&#xD;
      participants, (2c) ADHD indications will correlate with cognitive measures.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in working memory</measure>
    <time_frame>Baseline and 14 weeks</time_frame>
    <description>CANTAB Spatial Working Memory Task: SWM between errors</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in physical balance</measure>
    <time_frame>Baseline and 14 weeks</time_frame>
    <description>One Legged Stance Test. Time standing on one leg with eyes closed. Average over left and right leg of best of three trials on each side.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in impulsivity</measure>
    <time_frame>Baseline and 14 weeks</time_frame>
    <description>CANTAB Stop Signal Task: reaction time (SSRT).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in affective processing</measure>
    <time_frame>Baseline and 14 weeks</time_frame>
    <description>CANTAB Affective Go/No-Go Task: mean correct latency</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in attention deficit hyperactivity disorder (ADHD) scale</measure>
    <time_frame>Baseline and 14 weeks</time_frame>
    <description>World Health Organization adult ADHD self-report scale (ASRS). Scoring of 6 item ASRS screener per Kessler et al. Psychological Medicine (2005) 35:245-256.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of practice</measure>
    <time_frame>14 weeks</time_frame>
    <description>Total minutes of tai chi practice including class time.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">161</enrollment>
  <condition>Attention Deficit Disorder With Hyperactivity</condition>
  <arm_group>
    <arm_group_label>Tai Chi Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be recruited from the University of Wisconsin-Madison course, &quot;Introduction to Martial Arts: Tai Chi&quot;.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects will be recruited from the University of Wisconsin-Madison course &quot;Introduction to Psychology&quot;.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tai Chi training</intervention_name>
    <description>24 form Yang style Tai Chi. 50 minute sessions, twice weekly.</description>
    <arm_group_label>Tai Chi Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to perform balance and cognitive tests&#xD;
&#xD;
        Exclusion Criteria:&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>23 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexander K. Converse</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Wisconsin-Madison, Waisman Center</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Converse AK, Ahlers EO, Travers BG, Davidson RJ. Tai chi training reduces self-report of inattention in healthy young adults. Front Hum Neurosci. 2014 Jan 27;8:13. doi: 10.3389/fnhum.2014.00013. eCollection 2014.</citation>
    <PMID>24478679</PMID>
  </results_reference>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>May 7, 2021</last_update_submitted>
  <last_update_submitted_qc>May 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Attention Deficit Disorder with Hyperactivity</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/NCT01681082
org study id: SE-2012-0539
nct id: NCT01681082
lead sponsor: 
The general purpose of this study is to examine the effect of tai chi training on cognitive
      function in young adults. The investigators will test subjects enrolled in a semester-long
      tai chi course along with control subjects. The specific aims are to measure duration of
      practice, cognitive function, physical balance, and Attention Deficit Hyperactivity Disorder
      (ADHD) indicators. The investigators primary hypotheses are that, compared to controls,
      subjects in the tai chi course will show improvements in (1a) spatial working memory and (1b)
      response inhibition. The investigators secondary hypotheses are that, among the subjects
      participating in the tai chi course, these cognitive improvements will correlate with (2a)
      improvements in balance and (2b) duration of tai chi practice, and that, among all
      participants, (2c) ADHD indications will correlate with cognitive measures.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in working memory
time frame: Baseline and 14 weeks
description: CANTAB Spatial Working Memory Task: SWM between errors
measure: Change in physical balance
time frame: Baseline and 14 weeks
description: One Legged Stance Test. Time standing on one leg with eyes closed. Average over left and right leg of best of three trials on each side.
measure: Change in impulsivity
time frame: Baseline and 14 weeks
description: CANTAB Stop Signal Task: reaction time (SSRT).
measure: Change in affective processing
time frame: Baseline and 14 weeks
description: CANTAB Affective Go/No-Go Task: mean correct latency
measure: Change in attention deficit hyperactivity disorder (ADHD) scale
time frame: Baseline and 14 weeks
description: World Health Organization adult ADHD self-report scale (ASRS). Scoring of 6 item ASRS screener per Kessler et al. Psychological Medicine (2005) 35:245-256.
measure: Duration of practice
time frame: 14 weeks
description: Total minutes of tai chi practice including class time.
arm group label: Tai Chi Training
arm group type: Experimental
description: Subjects will be recruited from the University of Wisconsin-Madison course, "Introduction to Martial Arts: Tai Chi".
arm group label: Control
arm group type: No Intervention
description: Subjects will be recruited from the University of Wisconsin-Madison course "Introduction to Psychology".
intervention type: Behavioral
intervention name: Tai Chi training
description: 24 form Yang style Tai Chi. 50 minute sessions, twice weekly.
arm group label: Tai Chi Training
criteria: 
gender: All
minimum age: 18 Years
maximum age: 23 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alexander K. Converse
role: Principal Investigator
affiliation: University of Wisconsin, Madison
facility: 
country: United States
citation: Converse AK, Ahlers EO, Travers BG, Davidson RJ. Tai chi training reduces self-report of inattention in healthy young adults. Front Hum Neurosci. 2014 Jan 27;8:13. doi: 10.3389/fnhum.2014.00013. eCollection 2014.
PMID: 24478679
responsible party type: Sponsor
mesh term: Attention Deficit Disorder with Hyperactivity