<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/NCT04486989</url>
  </required_header>
  <id_info>
    <org_study_id>1R15DC017014-01A1</org_study_id>
    <secondary_id>0819.1s-ETSU</secondary_id>
    <nct_id>NCT04486989</nct_id>
  </id_info>
  <brief_title>Treatment for Teachers With Vocal Fatigue</brief_title>
  <official_title>Cardiovascular Conditioning in the Treatment of Vocal Fatigue</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>East Tennessee State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>East Tennessee State 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>
      Teachers are a population at high risk for voice disorders given their occupational demands.&#xD;
      In a teaching career, a common debilitating symptom among all vocal symptoms experienced is -&#xD;
      vocal fatigue, impacting teachers' occupational performance and increasing health care costs.&#xD;
      It is therefore essential to identify potential treatment options to alleviate the symptom of&#xD;
      vocal fatigue. The purpose of this study is to utilize a body-system level cardiovascular&#xD;
      training protocol in comparison to traditional voice production training to alleviate the&#xD;
      symptoms of vocal fatigue.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 4, 2020</start_date>
  <completion_date type="Anticipated">July 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">May 16, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Physiologic Cost of Speaking</measure>
    <time_frame>At baseline, at 4 weeks after treatment</time_frame>
    <description>Physiologic Cost of Speaking is measured as the rate of oxygen consumption at steady state/ rate of speech (wpm) for each of the two reading tasks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Oxygen Uptake Kinetics</measure>
    <time_frame>At baseline, at 4 weeks after treatment</time_frame>
    <description>Oxygen Uptake Kinetics is measured as the pattern of oxygen use during each of the two reading tasks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Post Task Physiological Recovery</measure>
    <time_frame>At baseline, at 4 weeks after treatment</time_frame>
    <description>Post Task Physiological Recovery is measured as the time, seconds, to reach baseline of oxygen consumption post task (within 0.2ml/kg/min) following each of the reading tasks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Excess Post Exercise Consumption (EPOC)</measure>
    <time_frame>At baseline, at 4 weeks after treatment</time_frame>
    <description>EPOC is measured as the magnitude of recovery oxygen consumption, ml/kg/min for each of the reading tasks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Ratings of Perceived Exertion (RPE)</measure>
    <time_frame>At baseline, at 4 weeks after treatment</time_frame>
    <description>Borg Scale of Ratings of Perceived Exertion (RPE)- measures the self-report of vocal effort for each of the reading tasks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Vocal Fatigue Index (VFI)</measure>
    <time_frame>At baseline, at 4 weeks after treatment</time_frame>
    <description>Vocal Fatigue Index (VFI) is a retrospective scale that measures self-reported symptoms of vocal fatigue</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Global Rating of Vocal Fatigue (VAS 100mm)</measure>
    <time_frame>At baseline, at 4 weeks after treatment</time_frame>
    <description>Global Rating of Vocal Fatigue (VAS 100mm) measures the ability to sustain voice with no fatigue at the end of a working day</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">52</enrollment>
  <condition>Vocal Fatigue</condition>
  <condition>Treatment</condition>
  <arm_group>
    <arm_group_label>Cardiovascular Conditioning Protocol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will complete a sub maximal cardiovascular training program twice per week for a period of 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Voice Production Exercises</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will complete voice production exercises twice per week for a period of 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cardiovascular Conditioning Protocol</intervention_name>
    <description>Participants will be randomized to either one of the treatment arms to receive treatment for a period of 4 weeks.</description>
    <arm_group_label>Cardiovascular Conditioning Protocol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Voice Production Exercises</intervention_name>
    <description>Participants will be randomized to either one of the treatment arms to receive treatment for a period of 4 weeks.</description>
    <arm_group_label>Voice Production Exercises</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female teachers between the ages of 21-60 years Female instructors and college&#xD;
             professors between the ages of 21-60 years&#xD;
&#xD;
          -  A score of ≥ 15 on factor 1 of the VFI (tiredness and avoidance of voice use) or a&#xD;
             score of ≤ 5 on factor 3 of the VFI (improvement of symptoms or lack thereof with&#xD;
             rest)&#xD;
&#xD;
          -  Sedentary- wherein participants will need to be completing mild intensity&#xD;
             cardiovascular exercise less than 150 minutes in less than 5 days per week&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Trained athletes&#xD;
&#xD;
          -  Trained singers&#xD;
&#xD;
          -  Smoking in the past 6months&#xD;
&#xD;
          -  Prior history of a vocal fold pathology and current vocal fold pathology&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Chaya Nanjundeswaran (Guntupalli), Ph.D.</last_name>
    <phone>423-439-4036</phone>
    <email>nanjundeswar@etsu.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>East Tennessee State University</name>
      <address>
        <city>Johnson City</city>
        <state>Tennessee</state>
        <zip>37614</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chaya Nanjundeswarn (Guntupalli), Ph.D.</last_name>
      <phone>423-439-4036</phone>
      <email>nanjundeswar@etsu.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>June 15, 2022</last_update_submitted>
  <last_update_submitted_qc>June 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>East Tennessee State University</investigator_affiliation>
    <investigator_full_name>Chayadevie Nanjundeswaran</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 2, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT04486989/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04486989
org study id: 1R15DC017014-01A1
secondary id: 0819.1s-ETSU
nct id: NCT04486989
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Teachers are a population at high risk for voice disorders given their occupational demands.
      In a teaching career, a common debilitating symptom among all vocal symptoms experienced is -
      vocal fatigue, impacting teachers' occupational performance and increasing health care costs.
      It is therefore essential to identify potential treatment options to alleviate the symptom of
      vocal fatigue. The purpose of this study is to utilize a body-system level cardiovascular
      training protocol in comparison to traditional voice production training to alleviate the
      symptoms of vocal fatigue.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in Physiologic Cost of Speaking
time frame: At baseline, at 4 weeks after treatment
description: Physiologic Cost of Speaking is measured as the rate of oxygen consumption at steady state/ rate of speech (wpm) for each of the two reading tasks
measure: Changes in Oxygen Uptake Kinetics
time frame: At baseline, at 4 weeks after treatment
description: Oxygen Uptake Kinetics is measured as the pattern of oxygen use during each of the two reading tasks
measure: Changes in Post Task Physiological Recovery
time frame: At baseline, at 4 weeks after treatment
description: Post Task Physiological Recovery is measured as the time, seconds, to reach baseline of oxygen consumption post task (within 0.2ml/kg/min) following each of the reading tasks
measure: Changes in Excess Post Exercise Consumption (EPOC)
time frame: At baseline, at 4 weeks after treatment
description: EPOC is measured as the magnitude of recovery oxygen consumption, ml/kg/min for each of the reading tasks
measure: Changes in Ratings of Perceived Exertion (RPE)
time frame: At baseline, at 4 weeks after treatment
description: Borg Scale of Ratings of Perceived Exertion (RPE)- measures the self-report of vocal effort for each of the reading tasks
measure: Changes in Vocal Fatigue Index (VFI)
time frame: At baseline, at 4 weeks after treatment
description: Vocal Fatigue Index (VFI) is a retrospective scale that measures self-reported symptoms of vocal fatigue
measure: Changes in Global Rating of Vocal Fatigue (VAS 100mm)
time frame: At baseline, at 4 weeks after treatment
description: Global Rating of Vocal Fatigue (VAS 100mm) measures the ability to sustain voice with no fatigue at the end of a working day
arm group label: Cardiovascular Conditioning Protocol
arm group type: Experimental
description: Participants will complete a sub maximal cardiovascular training program twice per week for a period of 4 weeks.
arm group label: Voice Production Exercises
arm group type: Active Comparator
description: Participants will complete voice production exercises twice per week for a period of 4 weeks.
intervention type: Behavioral
intervention name: Cardiovascular Conditioning Protocol
description: Participants will be randomized to either one of the treatment arms to receive treatment for a period of 4 weeks.
arm group label: Cardiovascular Conditioning Protocol
intervention type: Other
intervention name: Voice Production Exercises
description: Participants will be randomized to either one of the treatment arms to receive treatment for a period of 4 weeks.
arm group label: Voice Production Exercises
criteria: 
gender: Female
minimum age: 21 Years
maximum age: 45 Years
healthy volunteers: No
last name: Chaya Nanjundeswaran (Guntupalli), Ph.D.
phone: 423-439-4036
email: nanjundeswar@etsu.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: East Tennessee State University
investigator full name: Chayadevie Nanjundeswaran
investigator title: Associate Professor
mesh term: Fatigue
sharing ipd: No
provided document: 