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Effects of a Face Mask on Oxygenation During Exercise

Primary Purpose

Hypoxemia

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Progressive cycling exercise test to exhaustion

About this trial

This is an interventional treatment trial for Hypoxemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Experienced with cycling

Exclusion Criteria:

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

Sites / Locations

University of Saskatchewan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

No face mask

Disposable face mask

Cloth face mask

Arm Description

Progressive step-exercise cycling test to exhaustion wearing no face mask

Progressive step-exercise cycling test to exhaustion wearing a 3-ply disposable face mask

Progressive step-exercise cycling test to exhaustion wearing a cloth face mask

Outcomes

Primary Outcome Measures

Time to exhaustion during exercise

time to exhaustion

Change from baseline in peak power output

Peak power output in Watts, determined on a cycle ergometer

Secondary Outcome Measures

Change from baseline in blood oxygen saturation

Blood oxygen saturation as determined by pulse oximetry

Change from baseline in quadriceps tissue oxygenation index

Tissue oxygenation index (oxygenated hemoglobin/total hemoglobin) as measured by near infra-red spectroscopy

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

Change from baseline in heart rate

Heart rate (beats per minute)

Full Information

NCT ID

NCT04557605

First Posted

September 9, 2020

Last Updated

October 16, 2020

Sponsor

University of Saskatchewan

1. Study Identification

Unique Protocol Identification Number

NCT04557605

Brief Title

Effects of a Face Mask on Oxygenation During Exercise

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

September 14, 2020 (Actual)

Primary Completion Date

October 15, 2020 (Actual)

Study Completion Date

October 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Saskatchewan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypoxemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Masking Description

The individual who will statistically analyze the data will be blinded to condition

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

No face mask

Arm Type

Active Comparator

Arm Description

Progressive step-exercise cycling test to exhaustion wearing no face mask

Arm Title

Disposable face mask

Arm Type

Experimental

Arm Description

Progressive step-exercise cycling test to exhaustion wearing a 3-ply disposable face mask

Arm Title

Cloth face mask

Arm Type

Experimental

Arm Description

Progressive step-exercise cycling test to exhaustion wearing a cloth face mask

Intervention Type

Other

Intervention Name(s)

Progressive cycling exercise test to exhaustion

Intervention Description

Progressive step cycling exercise test to exhaustion

Primary Outcome Measure Information:

Title

Time to exhaustion during exercise

Description

time to exhaustion

Time Frame

Up to 20 minutes

Title

Change from baseline in peak power output

Description

Peak power output in Watts, determined on a cycle ergometer

Time Frame

Up to 20 minutes

Secondary Outcome Measure Information:

Title

Change from baseline in blood oxygen saturation

Description

Blood oxygen saturation as determined by pulse oximetry

Time Frame

Up to 20 minutes

Title

Change from baseline in quadriceps tissue oxygenation index

Description

Tissue oxygenation index (oxygenated hemoglobin/total hemoglobin) as measured by near infra-red spectroscopy

Time Frame

Up to 20 minutes

Title

Change from baseline in rating of perceived exertion

Description

Rating of perceived exertion on a scale of 1-10 (Modified Borg Scale), a higher score indicates a greater perceived exertion

Time Frame

Up to 20 minutes

Title

Change from baseline in heart rate

Description

Heart rate (beats per minute)

Time Frame

Up to 20 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Experienced with cycling Exclusion Criteria: Contra-indications to exercise as identified by a screening questionnaire (the "Get Active Questionnaire")

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philip Chilibeck, Ph.D.

Organizational Affiliation

University of Saskatchewan

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Saskatchewan

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7N5B2

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33153145

Citation

Shaw K, Butcher S, Ko J, Zello GA, Chilibeck PD. Wearing of Cloth or Disposable Surgical Face Masks has no Effect on Vigorous Exercise Performance in Healthy Individuals. Int J Environ Res Public Health. 2020 Nov 3;17(21):8110. doi: 10.3390/ijerph17218110.

Results Reference

derived

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Effects of a Face Mask on Oxygenation During Exercise

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