xml: <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/NCT06033755</url>
    </required_header>
    <id_info>
      <org_study_id>REC 2016/1723</org_study_id>
      <nct_id>NCT06033755</nct_id>
    </id_info>
    <brief_title>Managing Dysfunctional Breathing and Exercise-induced Laryngeal Obstruction in Adolescent Athletes</brief_title>
    <official_title>A Multidimensional Strategy to Managing Dysfunctional Breathing and Exercise-induced Laryngeal Obstruction in Adolescent Athletes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>VID Specialized University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Norwegian School of Sport Sciences</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>VID Specialized 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>
        This study aimed to assess if a multidimensional individually tailored intervention,&#xD;
        including Norwegian Psychomotor Physiotherapy (NPMP), elements of cognitive behavioural&#xD;
        therapy and a rehabilitation plan, helped reduce inspiratory distress and dysfunctional&#xD;
        breathing in adolescent athletes with EILO. A mixed methods design, which combined&#xD;
        qualitative and quantitative research, was used. Data, including subjective experiences of&#xD;
        respiratory distress, findings from NPMP body examinations and objective measurements of lung&#xD;
        function and aerobic capacity were gathered before and after a five month intervention&#xD;
        involving 18 participants.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 10, 2018</start_date>
    <completion_date type="Actual">January 30, 2023</completion_date>
    <primary_completion_date type="Actual">January 30, 2023</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>
      <intervention_model_description>A mixed methods design, which combined qualitative and quantitative research, was used. Data, including subjective experiences of respiratory distress, findings from physiotherapeutic body examinations and objective measurements of lung function and aerobic capacity were gathered before and after a five month intervention.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Subjective experiences of respiratory distress associated with exercise reported descriptively in an interview pre and post treatment</measure>
      <time_frame>Five months</time_frame>
      <description>Experiences of respiratory distress were explored through a history taking and in an qualitative interview based on a questionnaire developed by O. Roksund (2012) Larynx in exercising humans - the unexplored bottleneck of the airways. University of Bergen Norway (PhD thesis). The questionnaire is not developed for research purposes, and reliability and validity studies are lacking. It is however, functional as a basis for the pre and post interview in which respiratory distress was explored and is commonly used for the same purpose at Haukeland University hospital in Norway. The reporting was descriptive and qualitative, and no scale or scores were used.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">18</enrollment>
    <condition>Exercise Induced Laryngeal Obstruction (EILO)</condition>
    <arm_group>
      <arm_group_label>Participants with EILO were recruited and given treatment (i.e. one arm?)</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Only participants with EILO were recruited and given treatment as usual.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Norwegian psychomotor physiotherapy</intervention_name>
      <description>The intervention consisted predominantly of Norwegian Psychomotor Physiotherapy (NPMP) in which participants received individually tailored treatment based on the body examination and reported respiratory distress. NPMP addresses bodily tension, postural de-alignments and dysfunctional breathing patterns. The consultations also included a cognitive dimension, that is a conversation, in which thoughts and behaviours about training and competing were addressed and where participants were provided with &quot;self help&quot; measures that could improve breathing during training and competing. A rehabilitation plan for each participant was designed to limit further impairments and maintaining aerobic capacity without intensifying EILO symptoms. The intervention lasted 5 months.</description>
      <arm_group_label>Participants with EILO were recruited and given treatment (i.e. one arm?)</arm_group_label>
      <other_name>Elements of cognitive behavioural therapy</other_name>
      <other_name>Rehabilitation plan</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adolescent athletes with symptoms of EILO&#xD;
  &#xD;
            -  Referred to Norwegian Psychomotor Physiotherapy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Other respiratory symptoms&#xD;
  &#xD;
            -  Additional diagnosis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>13 Years</minimum_age>
      <maximum_age>19 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Liv-Jorunn Kolnes, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>VID Specialized University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Liv-Jorunn Kolnes</name>
        <address>
          <city>Oslo</city>
          <zip>0370</zip>
          <country>Norway</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Norway</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 27, 2023</study_first_submitted>
    <study_first_submitted_qc>September 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 9, 2023</last_update_submitted>
    <last_update_submitted_qc>September 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>EILO</keyword>
    <keyword>Physiotherapy intervention</keyword>
    <keyword>Dysfunctional breathing</keyword>
    <keyword>Adolescent athletes</keyword>
    <keyword>Diaphragmatic breathing</keyword>
    <keyword>Postural alignment</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiratory Aspiration</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The descriptive datasets concerning the body examinations generated during the study will not be publicly available du to individual privacy concerns, but will be available from the lead investigator on reasonable request.</ipd_description>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>All statistical material will be published in the article depicting the study. This will be submitted during august/september 2023.</ipd_time_frame>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06033755
  org study id: REC 2016/1723
  nct id: NCT06033755
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aimed to assess if a multidimensional individually tailored intervention,
        including Norwegian Psychomotor Physiotherapy (NPMP), elements of cognitive behavioural
        therapy and a rehabilitation plan, helped reduce inspiratory distress and dysfunctional
        breathing in adolescent athletes with EILO. A mixed methods design, which combined
        qualitative and quantitative research, was used. Data, including subjective experiences of
        respiratory distress, findings from NPMP body examinations and objective measurements of lung
        function and aerobic capacity were gathered before and after a five month intervention
        involving 18 participants.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: A mixed methods design, which combined qualitative and quantitative research, was used. Data, including subjective experiences of respiratory distress, findings from physiotherapeutic body examinations and objective measurements of lung function and aerobic capacity were gathered before and after a five month intervention.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Subjective experiences of respiratory distress associated with exercise reported descriptively in an interview pre and post treatment
  time frame: Five months
  description: Experiences of respiratory distress were explored through a history taking and in an qualitative interview based on a questionnaire developed by O. Roksund (2012) Larynx in exercising humans - the unexplored bottleneck of the airways. University of Bergen Norway (PhD thesis). The questionnaire is not developed for research purposes, and reliability and validity studies are lacking. It is however, functional as a basis for the pre and post interview in which respiratory distress was explored and is commonly used for the same purpose at Haukeland University hospital in Norway. The reporting was descriptive and qualitative, and no scale or scores were used.
  arm group label: Participants with EILO were recruited and given treatment (i.e. one arm?)
  arm group type: Other
  description: Only participants with EILO were recruited and given treatment as usual.
  intervention type: Other
  intervention name: Norwegian psychomotor physiotherapy
  description: The intervention consisted predominantly of Norwegian Psychomotor Physiotherapy (NPMP) in which participants received individually tailored treatment based on the body examination and reported respiratory distress. NPMP addresses bodily tension, postural de-alignments and dysfunctional breathing patterns. The consultations also included a cognitive dimension, that is a conversation, in which thoughts and behaviours about training and competing were addressed and where participants were provided with "self help" measures that could improve breathing during training and competing. A rehabilitation plan for each participant was designed to limit further impairments and maintaining aerobic capacity without intensifying EILO symptoms. The intervention lasted 5 months.
  arm group label: Participants with EILO were recruited and given treatment (i.e. one arm?)
  other name: Elements of cognitive behavioural therapy
  other name: Rehabilitation plan
  criteria: 
  gender: All
  minimum age: 13 Years
  maximum age: 19 Years
  healthy volunteers: No
  last name: Liv-Jorunn Kolnes, PhD
  role: Principal Investigator
  affiliation: VID Specialized University
  facility: 
  country: Norway
  responsible party type: Sponsor
  mesh term: Respiratory Aspiration
  sharing ipd: Yes
  ipd description: The descriptive datasets concerning the body examinations generated during the study will not be publicly available du to individual privacy concerns, but will be available from the lead investigator on reasonable request.
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: All statistical material will be published in the article depicting the study. This will be submitted during august/september 2023.