Effects of a Face Mask on Oxygenation During Exercise

Hypoxemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04557605
• Other study ID #: 2201
• Status: Completed
• Phase: N/A
• Start date: September 14, 2020
• Est. completion date: October 15, 2020

Study information

• Verified date: October 2020
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 15, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Experienced with cycling

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Hypoxemia
• Hypoxia

Intervention

Other:
• Progressive cycling exercise test to exhaustion
Progressive step cycling exercise test to exhaustion

Locations

Country	Name	City	State
Canada	University of Saskatchewan	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to exhaustion during exercise	time to exhaustion	Up to 20 minutes
Primary	Change from baseline in peak power output	Peak power output in Watts, determined on a cycle ergometer	Up to 20 minutes
Secondary	Change from baseline in blood oxygen saturation	Blood oxygen saturation as determined by pulse oximetry	Up to 20 minutes
Secondary	Change from baseline in quadriceps tissue oxygenation index	Tissue oxygenation index (oxygenated hemoglobin/total hemoglobin) as measured by near infra-red spectroscopy	Up to 20 minutes
Secondary	Change from baseline in rating of perceived exertion	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
Secondary	Change from baseline in heart rate	Heart rate (beats per minute)	Up to 20 minutes