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Effects of a Face Mask on Oxygenation During 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: NCT04557605
Recruitment Status : Completed
First Posted : September 21, 2020
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Phil Chilibeck, University of Saskatchewan

Brief Summary:
There is concern that wearing a face mask during COVID will affect oxygen uptake, especially during intense exercise. This study will assess the effect of wearing two different face masks (disposable and cloth) on blood and muscle oxygenation during cycling exercise.

Condition or disease Intervention/treatment Phase
Hypoxemia Other: Progressive cycling exercise test to exhaustion Not Applicable

Detailed Description:
There is concern that wearing a face mask during exercise will reduce oxygen uptake or increase carbon dioxide re-breathing, which can result in low blood oxygen levels, reduced oxygen delivery to muscle and reduced exercise capacity. The purpose of the study is to determine the effect of wearing two different types of commonly-worn face masks (diposable and cloth) during exercise on blood and muscle oxygenation. Twelve participants who are experienced with cycling will take part in this randomized cross-over study that will assess blood oxygenation (i.e. pulse oximetry) and muscle oxygenation (with near infrared spectroscopy) during a progressive step exercise test to exhaustion. The conditions include no mask, a disposable mask, and a cloth mask. Outcome variables include exercise duration, rating of perceived exertion, blood oxygen saturation levels, and oxygenated, deoxygenated, and total hemoglobin at the quadriceps muscle.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The individual who will statistically analyze the data will be blinded to condition
Primary Purpose: Treatment
Official Title: The Effects of Wearing a Face Mask During COVID-19 on Blood and Muscle Oxygenation While Performing Exercise
Actual Study Start Date : September 14, 2020
Actual Primary Completion Date : October 15, 2020
Actual Study Completion Date : October 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: No face mask
Progressive step-exercise cycling test to exhaustion wearing no face mask
Other: Progressive cycling exercise test to exhaustion
Progressive step cycling exercise test to exhaustion

Experimental: Disposable face mask
Progressive step-exercise cycling test to exhaustion wearing a 3-ply disposable face mask
Other: Progressive cycling exercise test to exhaustion
Progressive step cycling exercise test to exhaustion

Experimental: Cloth face mask
Progressive step-exercise cycling test to exhaustion wearing a cloth face mask
Other: Progressive cycling exercise test to exhaustion
Progressive step cycling exercise test to exhaustion




Primary Outcome Measures :
  1. Time to exhaustion during exercise [ Time Frame: Up to 20 minutes ]
    time to exhaustion

  2. Change from baseline in peak power output [ Time Frame: Up to 20 minutes ]
    Peak power output in Watts, determined on a cycle ergometer


Secondary Outcome Measures :
  1. Change from baseline in blood oxygen saturation [ Time Frame: Up to 20 minutes ]
    Blood oxygen saturation as determined by pulse oximetry

  2. Change from baseline in quadriceps tissue oxygenation index [ Time Frame: Up to 20 minutes ]
    Tissue oxygenation index (oxygenated hemoglobin/total hemoglobin) as measured by near infra-red spectroscopy

  3. Change from baseline in rating of perceived exertion [ Time Frame: Up to 20 minutes ]
    Rating of perceived exertion on a scale of 1-10 (Modified Borg Scale), a higher score indicates a greater perceived exertion

  4. Change from baseline in heart rate [ Time Frame: Up to 20 minutes ]
    Heart rate (beats per minute)



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:

  • Experienced with cycling

Exclusion Criteria:

  • Contra-indications to exercise as identified by a screening questionnaire (the "Get Active Questionnaire")

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): NCT04557605


Locations
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Canada, Saskatchewan
University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N5B2
Sponsors and Collaborators
University of Saskatchewan
Investigators
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Principal Investigator: Philip Chilibeck, Ph.D. University of Saskatchewan
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Phil Chilibeck, Professor, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT04557605    
Other Study ID Numbers: 2201
First Posted: September 21, 2020    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 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
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory