<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/NCT04498546</url>
  </required_header>
  <id_info>
    <org_study_id>KaratayU3</org_study_id>
    <nct_id>NCT04498546</nct_id>
  </id_info>
  <brief_title>Mask Usage and Exercise During the COVİD-19 Pandemic</brief_title>
  <official_title>The Effects of Mask Usage on Exercise Capacity and Related Parameters During the COVİD-19 Pandemic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KTO Karatay University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>KTO Karatay University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the effect of using mask during exercise on exercise capacity and values&#xD;
      measured before exercise (heart rate, blood pressure, peripheral oxygen saturation (SpO2),&#xD;
      fatigue, severity of dyspnea, etc.). To investigate the haemodynamic effects (heart rate,&#xD;
      blood pressure, peripheral oxygen saturation (SpO2), fatigue, dyspnea severity, etc.) of the&#xD;
      mask, which entered daily life during the epidemic period and which requires long-term use,&#xD;
      and examine the effect on hemodynamic stress.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Surgical masks are frequently used after the necessity to use a mask in the community.The&#xD;
      effects of technologically well-designed training masks used in athletes have been shown on&#xD;
      hypoxia and heart rate responses during exercise, but there are no studies examining the&#xD;
      exercise capacity and hemodynamic responses given to exercise in healthy normal&#xD;
      individuals.This study is planned to evaluate the effects of the use of surgical masks that&#xD;
      are widespread in the community due to pandemic on the exercise capacity and exercise&#xD;
      responses (heart rate, blood pressure, peripheral oxygen saturation, fatigue).&#xD;
&#xD;
      Exercise tests will be carried out for each individual randomly, twice with a mask and&#xD;
      without a mask. The materials used before and after each exercise test will be sterilized.&#xD;
      During the exercise test, individual antibacterial filters will be used for each person.Bruce&#xD;
      protocol will be used to determine exercise capacity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Actual">March 30, 2022</completion_date>
  <primary_completion_date type="Actual">March 30, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Days</target_duration>
  <primary_outcome>
    <measure>Resting Heart Rate</measure>
    <time_frame>baseline</time_frame>
    <description>Resting Heart Rate beats/min</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Peak Heart Rate</measure>
    <time_frame>During the procedure</time_frame>
    <description>Peak Heart Rate beats/min</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recovery Heart Rate</measure>
    <time_frame>Immediately after the procedure</time_frame>
    <description>Recovery Heart Rate beats/min</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Resting systolic blood pressure</measure>
    <time_frame>baseline</time_frame>
    <description>Resting systolic blood pressure mmHg</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recovery systolic blood pressure</measure>
    <time_frame>Immediately after the procedure</time_frame>
    <description>Recovery systolic blood pressure mmHg</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Resting diastolic blood pressure</measure>
    <time_frame>Baseline</time_frame>
    <description>Resting diastolic blood pressure mmHg</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recovery diastolic blood pressure</measure>
    <time_frame>Immediately after the procedure</time_frame>
    <description>Recovery diastolic blood pressure mmHg</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Peripheral oxygen saturation</measure>
    <time_frame>Baseline</time_frame>
    <description>To be measured by Pulse Oximeter (SpO2) To be measured by Pulse Oximeter (SpO2)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Peripheral oxygen saturation</measure>
    <time_frame>Immediately after the procedure</time_frame>
    <description>To be measured by Pulse Oximeter (SpO2)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VO2max</measure>
    <time_frame>Baseline</time_frame>
    <description>Maximal Oxygen Consumption (ml/kg/dk). Gas analyzer measuring breath to breath will be used.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dyspnoea Severity</measure>
    <time_frame>Baseline</time_frame>
    <description>It will be measured with a 20-point borg scale. As the score increases, the severity of dyspnea increases</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dyspnoea Severity</measure>
    <time_frame>Immediately after the procedure</time_frame>
    <description>It will be measured with a 20-point borg scale. As the score increases, the severity of dyspnea increases</description>
  </secondary_outcome>
  <enrollment type="Actual">49</enrollment>
  <condition>Exercise Test</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy volunteers between the ages of 18-65 who are able to perform exercise tests will be&#xD;
        included in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Volunteering to be included in the research,&#xD;
&#xD;
          -  Being between the ages of 18-65,&#xD;
&#xD;
          -  Having physical fitness to do exercise tests,&#xD;
&#xD;
          -  Having a cognitive function that will allow active participation in the exercise test.&#xD;
&#xD;
          -  No chronic illness.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not to volunteer to participate in the research,&#xD;
&#xD;
          -  Having any mental or physical condition that impedes performing exercise tests,&#xD;
&#xD;
          -  Having any of the symptoms of COVID-19,&#xD;
&#xD;
          -  Having been diagnosed with COVID-19 before,&#xD;
&#xD;
          -  Having a history of contact with COVID-19 patient&#xD;
&#xD;
          -  Having a cardiac, neurological, orthopedic and respiratory disease&#xD;
&#xD;
          -  Use of assistive devices while walking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Sevgi Özalevli, Prof, PT</last_name>
    <role>Study Director</role>
    <affiliation>Dokuz Eylul Univesity</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Özlem Akkoyun Sert, Phd, PT</last_name>
    <role>Study Chair</role>
    <affiliation>KTO Karatay University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KTO Karatay University</name>
      <address>
        <city>Konya</city>
        <state>Karatay</state>
        <zip>42030</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>August 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>April 5, 2022</last_update_submitted>
  <last_update_submitted_qc>April 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>KTO Karatay University</investigator_affiliation>
    <investigator_full_name>Büşra Alkan</investigator_full_name>
    <investigator_title>Research Assistant</investigator_title>
  </responsible_party>
  <keyword>exercise capacity</keyword>
  <keyword>surgical mask</keyword>
  <keyword>exercise test</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <!-- 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/NCT04498546
org study id: KaratayU3
nct id: NCT04498546
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To determine the effect of using mask during exercise on exercise capacity and values
      measured before exercise (heart rate, blood pressure, peripheral oxygen saturation (SpO2),
      fatigue, severity of dyspnea, etc.). To investigate the haemodynamic effects (heart rate,
      blood pressure, peripheral oxygen saturation (SpO2), fatigue, dyspnea severity, etc.) of the
      mask, which entered daily life during the epidemic period and which requires long-term use,
      and examine the effect on hemodynamic stress.
Surgical masks are frequently used after the necessity to use a mask in the community.The
      effects of technologically well-designed training masks used in athletes have been shown on
      hypoxia and heart rate responses during exercise, but there are no studies examining the
      exercise capacity and hemodynamic responses given to exercise in healthy normal
      individuals.This study is planned to evaluate the effects of the use of surgical masks that
      are widespread in the community due to pandemic on the exercise capacity and exercise
      responses (heart rate, blood pressure, peripheral oxygen saturation, fatigue).

      Exercise tests will be carried out for each individual randomly, twice with a mask and
      without a mask. The materials used before and after each exercise test will be sterilized.
      During the exercise test, individual antibacterial filters will be used for each person.Bruce
      protocol will be used to determine exercise capacity.
observational model: Other
time perspective: Prospective
measure: Resting Heart Rate
time frame: baseline
description: Resting Heart Rate beats/min
measure: Peak Heart Rate
time frame: During the procedure
description: Peak Heart Rate beats/min
measure: Recovery Heart Rate
time frame: Immediately after the procedure
description: Recovery Heart Rate beats/min
measure: Resting systolic blood pressure
time frame: baseline
description: Resting systolic blood pressure mmHg
measure: Recovery systolic blood pressure
time frame: Immediately after the procedure
description: Recovery systolic blood pressure mmHg
measure: Resting diastolic blood pressure
time frame: Baseline
description: Resting diastolic blood pressure mmHg
measure: Recovery diastolic blood pressure
time frame: Immediately after the procedure
description: Recovery diastolic blood pressure mmHg
measure: Peripheral oxygen saturation
time frame: Baseline
description: To be measured by Pulse Oximeter (SpO2) To be measured by Pulse Oximeter (SpO2)
measure: Peripheral oxygen saturation
time frame: Immediately after the procedure
description: To be measured by Pulse Oximeter (SpO2)
measure: VO2max
time frame: Baseline
description: Maximal Oxygen Consumption (ml/kg/dk). Gas analyzer measuring breath to breath will be used.
measure: Dyspnoea Severity
time frame: Baseline
description: It will be measured with a 20-point borg scale. As the score increases, the severity of dyspnea increases
measure: Dyspnoea Severity
time frame: Immediately after the procedure
description: It will be measured with a 20-point borg scale. As the score increases, the severity of dyspnea increases
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
last name: Sevgi Özalevli, Prof, PT
role: Study Director
affiliation: Dokuz Eylul Univesity
last name: Özlem Akkoyun Sert, Phd, PT
role: Study Chair
affiliation: KTO Karatay University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: KTO Karatay University
investigator full name: Büşra Alkan
investigator title: Research Assistant
mesh term: COVID-19