- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04557605
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
Intervention / Treatment
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.
Sponsor
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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