Effects of a Face Mask on Oxygenation During Exercise

October 16, 2020 updated by: Phil Chilibeck, University of Saskatchewan

The Effects of Wearing a Face Mask During COVID-19 on Blood and Muscle Oxygenation While Performing Exercise

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N5B2
        • University of Saskatchewan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Experienced with cycling

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: No face mask
Progressive step-exercise cycling test to exhaustion wearing no face mask
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
Progressive step cycling exercise test to exhaustion
Experimental: Cloth face mask
Progressive step-exercise cycling test to exhaustion wearing a cloth face mask
Progressive step cycling exercise test to exhaustion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to exhaustion during exercise
Time Frame: Up to 20 minutes
time to exhaustion
Up to 20 minutes
Change from baseline in peak power output
Time Frame: Up to 20 minutes
Peak power output in Watts, determined on a cycle ergometer
Up to 20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in blood oxygen saturation
Time Frame: Up to 20 minutes
Blood oxygen saturation as determined by pulse oximetry
Up to 20 minutes
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
Up to 20 minutes
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
Up to 20 minutes
Change from baseline in heart rate
Time Frame: Up to 20 minutes
Heart rate (beats per minute)
Up to 20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2020

Primary Completion (Actual)

October 15, 2020

Study Completion (Actual)

October 15, 2020

Study Registration Dates

First Submitted

September 9, 2020

First Submitted That Met QC Criteria

September 15, 2020

First Posted (Actual)

September 21, 2020

Study Record Updates

Last Update Posted (Actual)

October 20, 2020

Last Update Submitted That Met QC Criteria

October 16, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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