<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/NCT03286933</url>
  </required_header>
  <id_info>
    <org_study_id>CHLA-17-00037</org_study_id>
    <nct_id>NCT03286933</nct_id>
  </id_info>
  <brief_title>Yoga Therapy for Adolescents With Juvenile Idiopathic Arthritis</brief_title>
  <official_title>Yoga Therapy for Adolescents With Juvenile Idiopathic Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital Los Angeles</source>
  <oversight_info>
    <has_dmc>Yes</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 the study is to better understand the effects of a yoga program on adolescents&#xD;
      with juvenile idiopathic arthritis (JIA). The investigators want to learn whether or not a&#xD;
      yoga therapy based program will decrease pain and improve quality of life in patients with&#xD;
      JIA.&#xD;
&#xD;
      This is an 8-week program with home program of online videos.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an 8-week program consisting of weekly yoga therapy classes in a public studio. The&#xD;
      classes are led by a pediatric occupational therapist who is also a certified internationally&#xD;
      accredited yoga therapist (C-IAYT). The initial and final sessions will include an&#xD;
      Rheumatologist MD evaluation including a physician global assessment and joint damage&#xD;
      assessment (JADI) and visual assessment (VAS). A Visual Analog Pain Scale will and Peds&#xD;
      Quality of Life Questionnaire-Arthritis Module 4.0 will be administered. Each yoga class is&#xD;
      75 minutes to include a set-sequence of postures including breathing exercises and final&#xD;
      corpse pose (final relaxation).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 6, 2017</start_date>
  <completion_date type="Actual">June 26, 2017</completion_date>
  <primary_completion_date type="Actual">June 26, 2017</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Peds QL-Arthritis Module 4.0</measure>
    <time_frame>8 weeks</time_frame>
    <description>Measures perceived quality of life for adolescents with arthritis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analog Pain Scale</measure>
    <time_frame>8 weeks</time_frame>
    <description>Visual marker of perceived pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Assessment</measure>
    <time_frame>8 weeks</time_frame>
    <description>Physician visual assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Joint Damage Assessment (JADI)</measure>
    <time_frame>8 weeks</time_frame>
    <description>assessment of joints</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Adolescent Juvenile Idiopathic Arthritis</condition>
  <condition>Yoga Therapy</condition>
  <arm_group>
    <arm_group_label>Yoga therapy intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will participate in weekly yoga therapy sessions and have the opportunity to use the home video online.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>yoga</intervention_name>
    <description>75 minute weekly group yoga classes for 8 weeks. Home program online.</description>
    <arm_group_label>Yoga therapy intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adolescents with formal diagnosis of JIA, speak and understand English, can get on/off&#xD;
             floor independently.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dependent on assistive device for ambulation; does not understand English, does not&#xD;
             have a diagnosis of JIA.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Children's Hospital Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>September 15, 2017</last_update_submitted>
  <last_update_submitted_qc>September 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Children's Hospital Los Angeles</investigator_affiliation>
    <investigator_full_name>Adina</investigator_full_name>
    <investigator_title>Adina Schwartz, MA, OTR/L, Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>yoga therapy</keyword>
  <keyword>JIA</keyword>
  <keyword>quality of life</keyword>
  <keyword>pain management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Juvenile</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Participants will be coded and all data will be connected to their code. No names will be used after recruitment.</ipd_description>
  </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/NCT03286933
org study id: CHLA-17-00037
nct id: NCT03286933
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to better understand the effects of a yoga program on adolescents
      with juvenile idiopathic arthritis (JIA). The investigators want to learn whether or not a
      yoga therapy based program will decrease pain and improve quality of life in patients with
      JIA.

      This is an 8-week program with home program of online videos.
This is an 8-week program consisting of weekly yoga therapy classes in a public studio. The
      classes are led by a pediatric occupational therapist who is also a certified internationally
      accredited yoga therapist (C-IAYT). The initial and final sessions will include an
      Rheumatologist MD evaluation including a physician global assessment and joint damage
      assessment (JADI) and visual assessment (VAS). A Visual Analog Pain Scale will and Peds
      Quality of Life Questionnaire-Arthritis Module 4.0 will be administered. Each yoga class is
      75 minutes to include a set-sequence of postures including breathing exercises and final
      corpse pose (final relaxation).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Peds QL-Arthritis Module 4.0
time frame: 8 weeks
description: Measures perceived quality of life for adolescents with arthritis
measure: Visual Analog Pain Scale
time frame: 8 weeks
description: Visual marker of perceived pain
measure: Visual Assessment
time frame: 8 weeks
description: Physician visual assessment
measure: Joint Damage Assessment (JADI)
time frame: 8 weeks
description: assessment of joints
arm group label: Yoga therapy intervention
arm group type: Experimental
description: Participants will participate in weekly yoga therapy sessions and have the opportunity to use the home video online.
intervention type: Behavioral
intervention name: yoga
description: 75 minute weekly group yoga classes for 8 weeks. Home program online.
arm group label: Yoga therapy intervention
criteria: 
gender: All
minimum age: 14 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Children's Hospital Los Angeles
investigator full name: Adina
investigator title: Adina Schwartz, MA, OTR/L, Principal Investigator
mesh term: Arthritis
mesh term: Arthritis, Juvenile
sharing ipd: No
ipd description: Participants will be coded and all data will be connected to their code. No names will be used after recruitment.