<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/NCT03752164</url>
  </required_header>
  <id_info>
    <org_study_id>HM20014054</org_study_id>
    <nct_id>NCT03752164</nct_id>
  </id_info>
  <brief_title>Kids 2 Be &amp; Breathe: A Study on the Use of Yoga and Mindfulness in Children With Severe Asthma (K2B2)</brief_title>
  <acronym>K2B2</acronym>
  <official_title>Kids 2 Be &amp; Breathe: A Study on the Use of Yoga and Mindfulness in Children With Severe Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Virginia Commonwealth University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Virginia Commonwealth University</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>
      This proposed pilot study will examine the tolerability, feasibility, acceptability, and&#xD;
      preliminary effects of a gentle yoga intervention &quot;Kids 2 Be &amp; Breathe&quot; (K2B2; a manualized&#xD;
      30 minute gentle yoga and mindfulness session held one-on-one) in urban children aged 7-11&#xD;
      with severe asthma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pre-Intervention Assessment: permission/assent from the child and consent of the&#xD;
      parent/guardian will be obtained and initial data and measurements will be collected to&#xD;
      ensure continued eligibility; baseline measures will be assessed.&#xD;
&#xD;
      Intervention: participants will engage in a one-time manualized, age appropriate, 1:1,&#xD;
      30-minute intervention involving gentle yoga and mindfulness techniques in a private room in&#xD;
      the Pediatric Research Unit at the Children's Hospital of Richmond. The intervention will be&#xD;
      taught by certified and experienced child yoga instructors who have been trained in the study&#xD;
      protocol by the applicant. These yoga instructors collaborated with the interdisciplinary&#xD;
      research team in the development of manualized age-appropriate yoga sequences.&#xD;
      Parents/guardians will be invited to observe the yoga session. Intervention fidelity will be&#xD;
      maintained through the use of a manualized intervention and the PI observing all sessions for&#xD;
      manual consistency. The intervention will cease if the participant suffers from any asthma&#xD;
      symptoms during the intervention, such as wheezing, coughing, retractions, accessory muscle&#xD;
      use, chest tightness or shortness of breath, or experiences any other adverse events which&#xD;
      precludes the his or her ability to actively participate in the intervention.&#xD;
&#xD;
      Post-Intervention Assessment: upon completion of the intervention, brief semi-structured&#xD;
      interviews will be conducted with the child and parent/guardian separately in order to&#xD;
      explore the acceptability of the intervention and the PI will again assess the child for any&#xD;
      asthma symptoms or adverse events. Post-intervention pulmonary function test and vital sign&#xD;
      measurements will then be collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 9, 2019</start_date>
  <completion_date type="Actual">September 12, 2019</completion_date>
  <primary_completion_date type="Actual">September 12, 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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tolerability: FEV1%(forced expiratory volume in 1 second ) asthma symptoms and adverse events</measure>
    <time_frame>2 hours</time_frame>
    <description>whether intervention causes an exercise induced bronchoconstriction, asthma symptoms or adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Preliminary Effects: Change in FEV1</measure>
    <time_frame>Baseline to 2 hours</time_frame>
    <description>measuring the change in FEV1 pre and post intervention</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Yoga and Mindfulness</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An intervention consisting of one session lasting 30 minutes where a certified yoga instructor teaches the children gentle yoga and mindfulness skills.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Yoga and Mindfulness Skills</intervention_name>
    <description>Single brief session in which children are taught yoga and skills in mindfulness</description>
    <arm_group_label>Yoga and Mindfulness</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  on medium to high doses of steroids and/or leukotriene inhibitors&#xD;
&#xD;
          -  a Child-Asthma Control Test Score &lt;21&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  inability to speak English (child); inability to read/write English (parent/guardian)&#xD;
&#xD;
          -  child hospitalized in past two weeks for their asthma&#xD;
&#xD;
          -  current illness associated with oral temperature &gt;100.4&#xD;
&#xD;
          -  pulse ox &lt;95% and/or any wheezing, retractions or accessory muscle use&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sharon Lack</last_name>
    <role>Principal Investigator</role>
    <affiliation>Virginia Commonwealth University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital of Richmond</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>September 30, 2019</last_update_submitted>
  <last_update_submitted_qc>September 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2019</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>Asthma</mesh_term>
  </condition_browse>
  <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/NCT03752164
org study id: HM20014054
nct id: NCT03752164
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This proposed pilot study will examine the tolerability, feasibility, acceptability, and
      preliminary effects of a gentle yoga intervention "Kids 2 Be & Breathe" (K2B2; a manualized
      30 minute gentle yoga and mindfulness session held one-on-one) in urban children aged 7-11
      with severe asthma.
Pre-Intervention Assessment: permission/assent from the child and consent of the
      parent/guardian will be obtained and initial data and measurements will be collected to
      ensure continued eligibility; baseline measures will be assessed.

      Intervention: participants will engage in a one-time manualized, age appropriate, 1:1,
      30-minute intervention involving gentle yoga and mindfulness techniques in a private room in
      the Pediatric Research Unit at the Children's Hospital of Richmond. The intervention will be
      taught by certified and experienced child yoga instructors who have been trained in the study
      protocol by the applicant. These yoga instructors collaborated with the interdisciplinary
      research team in the development of manualized age-appropriate yoga sequences.
      Parents/guardians will be invited to observe the yoga session. Intervention fidelity will be
      maintained through the use of a manualized intervention and the PI observing all sessions for
      manual consistency. The intervention will cease if the participant suffers from any asthma
      symptoms during the intervention, such as wheezing, coughing, retractions, accessory muscle
      use, chest tightness or shortness of breath, or experiences any other adverse events which
      precludes the his or her ability to actively participate in the intervention.

      Post-Intervention Assessment: upon completion of the intervention, brief semi-structured
      interviews will be conducted with the child and parent/guardian separately in order to
      explore the acceptability of the intervention and the PI will again assess the child for any
      asthma symptoms or adverse events. Post-intervention pulmonary function test and vital sign
      measurements will then be collected.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Tolerability: FEV1%(forced expiratory volume in 1 second ) asthma symptoms and adverse events
time frame: 2 hours
description: whether intervention causes an exercise induced bronchoconstriction, asthma symptoms or adverse events
measure: Preliminary Effects: Change in FEV1
time frame: Baseline to 2 hours
description: measuring the change in FEV1 pre and post intervention
arm group label: Yoga and Mindfulness
arm group type: Experimental
description: An intervention consisting of one session lasting 30 minutes where a certified yoga instructor teaches the children gentle yoga and mindfulness skills.
intervention type: Behavioral
intervention name: Yoga and Mindfulness Skills
description: Single brief session in which children are taught yoga and skills in mindfulness
arm group label: Yoga and Mindfulness
criteria: 
gender: All
minimum age: 7 Years
maximum age: 11 Years
healthy volunteers: No
last name: Sharon Lack
role: Principal Investigator
affiliation: Virginia Commonwealth University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Asthma
sharing ipd: No