<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/NCT04415879</url>
  </required_header>
  <id_info>
    <org_study_id>20-538</org_study_id>
    <nct_id>NCT04415879</nct_id>
  </id_info>
  <brief_title>Effects of a N95 Respirator vs Cloth Mask on Exercise Capacity During Treadmill Exercise.</brief_title>
  <official_title>Effects of a N95 Respirator vs Cloth Mask on Exercise Capacity During Treadmill Exercise.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</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 intends to find out how a cloth mask may impact exercise capacity, to provide&#xD;
      guidance for exercisers to adjust their expectations and training accordingly. The&#xD;
      investigators plan to asses exercise capacity through estimated peak oxygen consumption&#xD;
      (eVO2peak), oxygen saturation and level of perceived exertion during treadmill based exercise&#xD;
      while wearing a cloth mask compared to exercising without a cloth mask. The potential&#xD;
      significance of this study is to determine if subjects can exercise safely and if their&#xD;
      exercise training needs to be adjusted while following the current recommendations of wearing&#xD;
      a cloth mask in public. The degree of airflow limitation experienced will depend on the type&#xD;
      and fit of the mask being worn, and inadequeate airflow could possibly result in CO2&#xD;
      re-breathing if all air was not fully discharged from the mask with each breath. This&#xD;
      re-breathing of CO2 could potentially limit the workload leading to a detriment in&#xD;
      performance, and increase in adverse symptoms such as dizziness, lightheadedness, chest pain&#xD;
      or shortness of breath that does not improve with rest.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      If healthcare providers are going to recommend that individuals exercise with cloth masks, it&#xD;
      is imperative that future research is conducted to evaluate the degree to which airflow can&#xD;
      be limited during exercise by wearing a cloth mask. At the completion of the study, the&#xD;
      investigators will have further understanding of the effects of face masks during treadmill&#xD;
      based running. To the investigators knowledge this is the first study to assess the effects&#xD;
      of wearing protective cloth mask on exercise capacity.&#xD;
&#xD;
      Hypothesis The null hypothesis HO states that exercising with a cloth mask will be inferior&#xD;
      to the current standard of exercising without a facemask, limiting peak exercise when&#xD;
      non-inferiority margin is 1 estimated metabolic equivalent ( eMET 3.5 mlO2*kg-1*min-1).&#xD;
&#xD;
      The alternative hypothesis H1 states that exercising with a mask will not be inferior to the&#xD;
      current standard of exercising without a facemask, limiting peak exercise when&#xD;
      non-inferiority margin is 1 eMET.&#xD;
&#xD;
      EXPERIMENTAL DESIGN &amp; METHODS Subject Recruitment: The investigators will recruit 20 subjects&#xD;
      though the Cleveland Clinic. Inclusion Criteria: Healthy subjects age &gt; 18, Exclusion&#xD;
      Criteria: Any long-term disease that would interfere with their ability to exercise safely,&#xD;
      fever &gt;100.4 F, or pregnancy. Informed consent will be obtained by the CoPI, and need for&#xD;
      medical clearance determined based on ACSM's 2015 preparticipation guidelines. To remain&#xD;
      compliant with enterprise guidelines we will not be recruiting healthy subjects outside of&#xD;
      the Cleveland Clinic staff at this time to avoid increase COVID-19 exposure risk. However, if&#xD;
      the enterprise changes the guidelines we will expand our enrollment to include non Cleveland&#xD;
      Clinic employees. Employees will not be solicited by direct initiation. Recruitment will&#xD;
      involve only posted notice or general advertising that does not pressure employees into&#xD;
      participating for fear of job loss, delayed promotion, or other influences from their&#xD;
      superior.&#xD;
&#xD;
      Study Design: The study design is a prospective crossover non-inferiority trial where&#xD;
      subjects will complete 3 separate graded exercise treadmill tests each time wearing either No&#xD;
      Mask, N-95 Mask (3M), or Cloth Mask (Boco). The order of the mask worn will be randomly&#xD;
      assign to minimize familiarization or training effect. All testing will be performed in a&#xD;
      Cleveland Clinic facility following standardized COVID-19 screening precautions. The&#xD;
      investigators will compare the data collected from each test to asses for differences between&#xD;
      subject comfort, peak exercise capacity (eMET), heart rate response during exercise and&#xD;
      recovery.&#xD;
&#xD;
      Testing: After completing the informed consent and being medically cleared, subjects will&#xD;
      then perform a symptom limited graded exercise treadmill test using a modified Balke protocol&#xD;
      with continuous 12-lead EKG monitoring. Exercise tests will be stopped if any significant&#xD;
      cardiac arrhythmias occur or significant ST segment depressions develops. The test will be&#xD;
      terminated if ST elevation (&gt; 1.0 mm), marked ST displacement (horizontal or downsloping of &gt;&#xD;
      2mm, measured 60 to 80 ms after the J point), moderate to severe angina, Signs of poor&#xD;
      perfusion (cyanosis or pallor), Sustained ventricular tachycardia or other arrhythmia,&#xD;
      including second or third decree AV block, that interferes with normal maintenance of cardiac&#xD;
      output during exercise, or development of bunle-branch block that cnannot be distinguished&#xD;
      from bentricular tachycardia. The modified Balke, which is a well-accepted treadmill protocol&#xD;
      that keeps the speed constant and increases workload by grade. Subjects will rest for 3&#xD;
      minutes and resting heart rate, blood pressure, subjective perceptions of the face mask will&#xD;
      be measured. Subjects then will walk at 0% grade at 3 miles per hour for 2 minutes. Elevation&#xD;
      will be increased by 2% after the initial 2 minutes and by 1% each minute thereafter until&#xD;
      the test is terminated. Heart rate, RPEand oxygen saturation will be measured with a pulse&#xD;
      oximeter at baseline, last 5-10 seconds of each stage and the investigators will continue to&#xD;
      monitor heart rate during recovery at 1, 3 and 5 minutes post exercise. The investigators&#xD;
      will monitor each stage for perceived exertion, feelings of light headedness, anxiety, and&#xD;
      discomfort. The test will also be terminated at the request of the subject or if any chest&#xD;
      pain develops. The scale of measuring subjective perceptions instrument will be adminstereted&#xD;
      after collecting 5 minutes of resting, end of the exercise test, and at 5 minutes post&#xD;
      recovery. The graded exercise test will be performed once with No Mask, once with a 3M 8200&#xD;
      N-95 Respirator, and once with a Cloth Mask (Boco). Subjects will be randomized by a random&#xD;
      number generater (1= No Mask, 2= N-95, 3= Cloth Mask) to determine the order the perform each&#xD;
      exercise test No Mask, N-95 or Cloth Mask and will complete the other tests 2 atleast 1 day&#xD;
      apart. Subjects will be instructed to abstain from exercise for 2 days before the test.&#xD;
&#xD;
      Mask:&#xD;
&#xD;
      3M 8200 N-95 Respirator obtain from a third party provider. N-95 Respirators have been&#xD;
      purchased outside the Cleveland Clinic supply chain. Cloth Face Mask manufactured by Boco is&#xD;
      a custom designed two-layer face masks are built with a tightly woven polyester outer shell&#xD;
      fabric and a soft, breathable performance knit mesh inner linig. Includes a slit pocket where&#xD;
      a filter can be added.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">August 1, 2020</completion_date>
  <primary_completion_date type="Actual">August 1, 2020</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>Crossover Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Exercise Capacity</measure>
    <time_frame>4 Weeks</time_frame>
    <description>To gain further understanding on effects exercising with a cloth mask has on exercise capacity. Our working hypothesis is that wearing a face mask will limit exercise capacity by a minimal clinically important difference (MCID) of 1 estimated Metabolic Equivalent (eMET 3.5 O2 ml/kg/min).</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>No Mask</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Individuals will perform a Modified Balke Treadmill test with no mask and their estimated VO2 peak will be calculated based off of peak workload.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>N-95 Respirator</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individuals will perform a Modified Balke Treadmill test while wearing a N-95 Respirator and their estimated VO2 peak will be calculated based off of peak workload.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cloth Mask</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individuals will perform a Modified Balke Treadmill test while wearing a cloth mask and their estimated VO2 peak will be calculated based off of peak workload.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>N-95 Respirator</intervention_name>
    <description>N-95 mask will be worn as personal protective equipment during a graded exercise test</description>
    <arm_group_label>Cloth Mask</arm_group_label>
    <arm_group_label>N-95 Respirator</arm_group_label>
    <arm_group_label>No Mask</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cloth Face Mask</intervention_name>
    <description>A cloth mask will be worn as personal protective equipment during a graded exercise test</description>
    <arm_group_label>Cloth Mask</arm_group_label>
    <arm_group_label>N-95 Respirator</arm_group_label>
    <arm_group_label>No Mask</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Graded exercise test</intervention_name>
    <description>No personal protective equipment during a graded exercise test</description>
    <arm_group_label>Cloth Mask</arm_group_label>
    <arm_group_label>N-95 Respirator</arm_group_label>
    <arm_group_label>No Mask</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Cleveland Clinic Employee&#xD;
&#xD;
          -  Must not be pregnant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical condition that would interfere with ability to exercise safely&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>August 12, 2020</last_update_submitted>
  <last_update_submitted_qc>August 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
    <investigator_full_name>Debasis Sahoo</investigator_full_name>
    <investigator_title>Staff Physician</investigator_title>
  </responsible_party>
  <keyword>Exercise</keyword>
  <keyword>Face Mask</keyword>
  <keyword>COVID-19</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04415879
org study id: 20-538
nct id: NCT04415879
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study intends to find out how a cloth mask may impact exercise capacity, to provide
      guidance for exercisers to adjust their expectations and training accordingly. The
      investigators plan to asses exercise capacity through estimated peak oxygen consumption
      (eVO2peak), oxygen saturation and level of perceived exertion during treadmill based exercise
      while wearing a cloth mask compared to exercising without a cloth mask. The potential
      significance of this study is to determine if subjects can exercise safely and if their
      exercise training needs to be adjusted while following the current recommendations of wearing
      a cloth mask in public. The degree of airflow limitation experienced will depend on the type
      and fit of the mask being worn, and inadequeate airflow could possibly result in CO2
      re-breathing if all air was not fully discharged from the mask with each breath. This
      re-breathing of CO2 could potentially limit the workload leading to a detriment in
      performance, and increase in adverse symptoms such as dizziness, lightheadedness, chest pain
      or shortness of breath that does not improve with rest.
If healthcare providers are going to recommend that individuals exercise with cloth masks, it
      is imperative that future research is conducted to evaluate the degree to which airflow can
      be limited during exercise by wearing a cloth mask. At the completion of the study, the
      investigators will have further understanding of the effects of face masks during treadmill
      based running. To the investigators knowledge this is the first study to assess the effects
      of wearing protective cloth mask on exercise capacity.

      Hypothesis The null hypothesis HO states that exercising with a cloth mask will be inferior
      to the current standard of exercising without a facemask, limiting peak exercise when
      non-inferiority margin is 1 estimated metabolic equivalent ( eMET 3.5 mlO2*kg-1*min-1).

      The alternative hypothesis H1 states that exercising with a mask will not be inferior to the
      current standard of exercising without a facemask, limiting peak exercise when
      non-inferiority margin is 1 eMET.

      EXPERIMENTAL DESIGN & METHODS Subject Recruitment: The investigators will recruit 20 subjects
      though the Cleveland Clinic. Inclusion Criteria: Healthy subjects age > 18, Exclusion
      Criteria: Any long-term disease that would interfere with their ability to exercise safely,
      fever >100.4 F, or pregnancy. Informed consent will be obtained by the CoPI, and need for
      medical clearance determined based on ACSM's 2015 preparticipation guidelines. To remain
      compliant with enterprise guidelines we will not be recruiting healthy subjects outside of
      the Cleveland Clinic staff at this time to avoid increase COVID-19 exposure risk. However, if
      the enterprise changes the guidelines we will expand our enrollment to include non Cleveland
      Clinic employees. Employees will not be solicited by direct initiation. Recruitment will
      involve only posted notice or general advertising that does not pressure employees into
      participating for fear of job loss, delayed promotion, or other influences from their
      superior.

      Study Design: The study design is a prospective crossover non-inferiority trial where
      subjects will complete 3 separate graded exercise treadmill tests each time wearing either No
      Mask, N-95 Mask (3M), or Cloth Mask (Boco). The order of the mask worn will be randomly
      assign to minimize familiarization or training effect. All testing will be performed in a
      Cleveland Clinic facility following standardized COVID-19 screening precautions. The
      investigators will compare the data collected from each test to asses for differences between
      subject comfort, peak exercise capacity (eMET), heart rate response during exercise and
      recovery.

      Testing: After completing the informed consent and being medically cleared, subjects will
      then perform a symptom limited graded exercise treadmill test using a modified Balke protocol
      with continuous 12-lead EKG monitoring. Exercise tests will be stopped if any significant
      cardiac arrhythmias occur or significant ST segment depressions develops. The test will be
      terminated if ST elevation (> 1.0 mm), marked ST displacement (horizontal or downsloping of >
      2mm, measured 60 to 80 ms after the J point), moderate to severe angina, Signs of poor
      perfusion (cyanosis or pallor), Sustained ventricular tachycardia or other arrhythmia,
      including second or third decree AV block, that interferes with normal maintenance of cardiac
      output during exercise, or development of bunle-branch block that cnannot be distinguished
      from bentricular tachycardia. The modified Balke, which is a well-accepted treadmill protocol
      that keeps the speed constant and increases workload by grade. Subjects will rest for 3
      minutes and resting heart rate, blood pressure, subjective perceptions of the face mask will
      be measured. Subjects then will walk at 0% grade at 3 miles per hour for 2 minutes. Elevation
      will be increased by 2% after the initial 2 minutes and by 1% each minute thereafter until
      the test is terminated. Heart rate, RPEand oxygen saturation will be measured with a pulse
      oximeter at baseline, last 5-10 seconds of each stage and the investigators will continue to
      monitor heart rate during recovery at 1, 3 and 5 minutes post exercise. The investigators
      will monitor each stage for perceived exertion, feelings of light headedness, anxiety, and
      discomfort. The test will also be terminated at the request of the subject or if any chest
      pain develops. The scale of measuring subjective perceptions instrument will be adminstereted
      after collecting 5 minutes of resting, end of the exercise test, and at 5 minutes post
      recovery. The graded exercise test will be performed once with No Mask, once with a 3M 8200
      N-95 Respirator, and once with a Cloth Mask (Boco). Subjects will be randomized by a random
      number generater (1= No Mask, 2= N-95, 3= Cloth Mask) to determine the order the perform each
      exercise test No Mask, N-95 or Cloth Mask and will complete the other tests 2 atleast 1 day
      apart. Subjects will be instructed to abstain from exercise for 2 days before the test.

      Mask:

      3M 8200 N-95 Respirator obtain from a third party provider. N-95 Respirators have been
      purchased outside the Cleveland Clinic supply chain. Cloth Face Mask manufactured by Boco is
      a custom designed two-layer face masks are built with a tightly woven polyester outer shell
      fabric and a soft, breathable performance knit mesh inner linig. Includes a slit pocket where
      a filter can be added.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Exercise Capacity
time frame: 4 Weeks
description: To gain further understanding on effects exercising with a cloth mask has on exercise capacity. Our working hypothesis is that wearing a face mask will limit exercise capacity by a minimal clinically important difference (MCID) of 1 estimated Metabolic Equivalent (eMET 3.5 O2 ml/kg/min).
arm group label: No Mask
arm group type: Active Comparator
description: Individuals will perform a Modified Balke Treadmill test with no mask and their estimated VO2 peak will be calculated based off of peak workload.
arm group label: N-95 Respirator
arm group type: Experimental
description: Individuals will perform a Modified Balke Treadmill test while wearing a N-95 Respirator and their estimated VO2 peak will be calculated based off of peak workload.
arm group label: Cloth Mask
arm group type: Experimental
description: Individuals will perform a Modified Balke Treadmill test while wearing a cloth mask and their estimated VO2 peak will be calculated based off of peak workload.
intervention type: Device
intervention name: N-95 Respirator
description: N-95 mask will be worn as personal protective equipment during a graded exercise test
arm group label: Cloth Mask
arm group label: N-95 Respirator
arm group label: No Mask
intervention type: Device
intervention name: Cloth Face Mask
description: A cloth mask will be worn as personal protective equipment during a graded exercise test
arm group label: Cloth Mask
arm group label: N-95 Respirator
arm group label: No Mask
intervention type: Diagnostic Test
intervention name: Graded exercise test
description: No personal protective equipment during a graded exercise test
arm group label: Cloth Mask
arm group label: N-95 Respirator
arm group label: No Mask
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The Cleveland Clinic
investigator full name: Debasis Sahoo
investigator title: Staff Physician
mesh term: COVID-19
sharing ipd: No