<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/NCT03304327</url>
  </required_header>
  <id_info>
    <org_study_id>pro00086819</org_study_id>
    <nct_id>NCT03304327</nct_id>
  </id_info>
  <brief_title>Mindfulness and Yoga Training for Athletes With Concussion (MYTAC)</brief_title>
  <acronym>(MYTAC)</acronym>
  <official_title>Mindfulness and Yoga Training for Athletes With Concussion (MYTAC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</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>
      The purpose of this study is to establish the tolerability of mindfulness and yoga therapy in&#xD;
      the post-concussion period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Athletes and patients aged 15 - 60 will receive standard sports concussion evaluations at the&#xD;
      Duke Sports Science Institute (SSI) and will learn about the study by the primary clinicians&#xD;
      evaluating sports concussion at the SSI. Subjects will receive yoga training either at their&#xD;
      home or at the Center for Living Campus at Duke. Subjects will complete their yoga&#xD;
      assignments for 5 consecutive days, along with a symptom checklist. On the 6th day, subjects&#xD;
      will complete the symptom checklist and mail all checklists to the study team in a stamped&#xD;
      envelope. We expect to enroll 20 subjects.&#xD;
&#xD;
      If a subject has significant worsening of their symptoms and wishes to discontinue the study,&#xD;
      they are requested to contact the study PI, Joel Morgenlander, MD. At that time, Dr.&#xD;
      Morgenlander will document the specific reasons for discontinuation of the protocol. All&#xD;
      follow-up care for their concussion will be through the provider they are already seeing for&#xD;
      concussion. There is no significant risk to the athlete for participation except possible&#xD;
      transient increase in their concussion symptoms. Benefits include possible hastening of&#xD;
      recovery from their concussive symptoms and receiving training in mindfulness and yoga from a&#xD;
      certified yoga instructor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 27, 2017</start_date>
  <completion_date type="Actual">September 23, 2019</completion_date>
  <primary_completion_date type="Actual">September 23, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tolerability of mindfulness yoga therapy in the post-concussion period as measured by a rating scale.</measure>
    <time_frame>up to 7 days</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Concussion</condition>
  <arm_group>
    <arm_group_label>Mindfullness and Yoga</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive yoga training either at their home or at the Center for Living Campus at Duke. Subjects will complete their yoga assignments for 5 consecutive days, along with a symptom checklist. On the 6th day, subjects will complete the symptom checklist and mail all checklists to the study team</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness and Yoga Training</intervention_name>
    <description>Centering and Breathing- Practice begins by turning attention to the breath to help participants make the transition from the busy, doing, outward focus of daily life into the mindful, balanced, internal focus central to yoga practice.&#xD;
Practices:Breath awareness, the relaxed abdominal breath. Posture Practice-Warm up with the range-of-motion sequence to take the major joints of the body through their full range of motion.This is done lying down with the head on the floor; the head can be supported by a small, folded towel if desired.&#xD;
Practices: Knee-to-chest sequence, Arms and Shoulders, Gentle Spinal Twist, Apanasana.&#xD;
Standing Poses for Strength and Balance, to enhance function and confidence. Practices: Mountain Pose, Flying Crane Sequence, Tree Pose, Warrior 2 and Side Angle.&#xD;
Relaxation- Practice concludes with guided relaxation to quiet the mind and calm the body.&#xD;
Practices: Seated Mountain Pose, even breath, extended exhalation,Yoga Nidra.</description>
    <arm_group_label>Mindfullness and Yoga</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Injury sustained within 30 days of enrollment&#xD;
&#xD;
          -  Being seen for concussion at the Sports Science Institute (SSI) at Duke University&#xD;
             Medical Center&#xD;
&#xD;
          -  living in a 30 mile radius of the SSI&#xD;
&#xD;
          -  SCAT5 (Sport Concussion Assessment Tool 5) modified symptom checklist score of greater&#xD;
             than 12&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joel Morgenlander</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>October 3, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>March 25, 2020</last_update_submitted>
  <last_update_submitted_qc>March 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Yoga</keyword>
  <keyword>Mindfulness</keyword>
  <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/NCT03304327
org study id: pro00086819
nct id: NCT03304327
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to establish the tolerability of mindfulness and yoga therapy in
      the post-concussion period.
Athletes and patients aged 15 - 60 will receive standard sports concussion evaluations at the
      Duke Sports Science Institute (SSI) and will learn about the study by the primary clinicians
      evaluating sports concussion at the SSI. Subjects will receive yoga training either at their
      home or at the Center for Living Campus at Duke. Subjects will complete their yoga
      assignments for 5 consecutive days, along with a symptom checklist. On the 6th day, subjects
      will complete the symptom checklist and mail all checklists to the study team in a stamped
      envelope. We expect to enroll 20 subjects.

      If a subject has significant worsening of their symptoms and wishes to discontinue the study,
      they are requested to contact the study PI, Joel Morgenlander, MD. At that time, Dr.
      Morgenlander will document the specific reasons for discontinuation of the protocol. All
      follow-up care for their concussion will be through the provider they are already seeing for
      concussion. There is no significant risk to the athlete for participation except possible
      transient increase in their concussion symptoms. Benefits include possible hastening of
      recovery from their concussive symptoms and receiving training in mindfulness and yoga from a
      certified yoga instructor.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Tolerability of mindfulness yoga therapy in the post-concussion period as measured by a rating scale.
time frame: up to 7 days
arm group label: Mindfullness and Yoga
arm group type: Experimental
description: Subjects will receive yoga training either at their home or at the Center for Living Campus at Duke. Subjects will complete their yoga assignments for 5 consecutive days, along with a symptom checklist. On the 6th day, subjects will complete the symptom checklist and mail all checklists to the study team
intervention type: Behavioral
intervention name: Mindfulness and Yoga Training
description: Centering and Breathing- Practice begins by turning attention to the breath to help participants make the transition from the busy, doing, outward focus of daily life into the mindful, balanced, internal focus central to yoga practice.
Practices:Breath awareness, the relaxed abdominal breath. Posture Practice-Warm up with the range-of-motion sequence to take the major joints of the body through their full range of motion.This is done lying down with the head on the floor; the head can be supported by a small, folded towel if desired.
Practices: Knee-to-chest sequence, Arms and Shoulders, Gentle Spinal Twist, Apanasana.
Standing Poses for Strength and Balance, to enhance function and confidence. Practices: Mountain Pose, Flying Crane Sequence, Tree Pose, Warrior 2 and Side Angle.
Relaxation- Practice concludes with guided relaxation to quiet the mind and calm the body.
Practices: Seated Mountain Pose, even breath, extended exhalation,Yoga Nidra.
arm group label: Mindfullness and Yoga
criteria: 
gender: All
minimum age: 15 Years
maximum age: 60 Years
healthy volunteers: No
last name: Joel Morgenlander
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No