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Effects of a N95 Respirator vs Cloth Mask on Exercise Capacity During Treadmill Exercise.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04415879
Recruitment Status : Completed
First Posted : June 4, 2020
Last Update Posted : August 13, 2020
Sponsor:
Information provided by (Responsible Party):
Debasis Sahoo, The Cleveland Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
COVID-19 Device: N-95 Respirator Device: Cloth Face Mask Diagnostic Test: Graded exercise test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effects of a N95 Respirator vs Cloth Mask on Exercise Capacity During Treadmill Exercise.
Actual Study Start Date : June 1, 2020
Actual Primary Completion Date : August 1, 2020
Actual Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: No Mask
Individuals will perform a Modified Balke Treadmill test with no mask and their estimated VO2 peak will be calculated based off of peak workload.
Device: N-95 Respirator
N-95 mask will be worn as personal protective equipment during a graded exercise test

Device: Cloth Face Mask
A cloth mask will be worn as personal protective equipment during a graded exercise test

Diagnostic Test: Graded exercise test
No personal protective equipment during a graded exercise test

Experimental: N-95 Respirator
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.
Device: N-95 Respirator
N-95 mask will be worn as personal protective equipment during a graded exercise test

Device: Cloth Face Mask
A cloth mask will be worn as personal protective equipment during a graded exercise test

Diagnostic Test: Graded exercise test
No personal protective equipment during a graded exercise test

Experimental: Cloth Mask
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.
Device: N-95 Respirator
N-95 mask will be worn as personal protective equipment during a graded exercise test

Device: Cloth Face Mask
A cloth mask will be worn as personal protective equipment during a graded exercise test

Diagnostic Test: Graded exercise test
No personal protective equipment during a graded exercise test




Primary Outcome Measures :
  1. Exercise Capacity [ Time Frame: 4 Weeks ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 years or older
  • Cleveland Clinic Employee
  • Must not be pregnant

Exclusion Criteria:

  • Medical condition that would interfere with ability to exercise safely

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04415879


Locations
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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
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Responsible Party: Debasis Sahoo, Staff Physician, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT04415879    
Other Study ID Numbers: 20-538
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: August 13, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Debasis Sahoo, The Cleveland Clinic:
Exercise
Face Mask
COVID-19