NCT04557605

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

September 14, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2020

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

1 month

First QC Date

September 9, 2020

Last Update Submit

October 16, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Time to exhaustion during exercise

    time to exhaustion

    Up to 20 minutes

  • Change from baseline in peak power output

    Peak power output in Watts, determined on a cycle ergometer

    Up to 20 minutes

Secondary Outcomes (4)

  • Change from baseline in blood oxygen saturation

    Up to 20 minutes

  • Change from baseline in quadriceps tissue oxygenation index

    Up to 20 minutes

  • Change from baseline in rating of perceived exertion

    Up to 20 minutes

  • Change from baseline in heart rate

    Up to 20 minutes

Study Arms (3)

No face mask

ACTIVE COMPARATOR

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

Other: Progressive cycling exercise test to exhaustion

Disposable face mask

EXPERIMENTAL

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

Other: Progressive cycling exercise test to exhaustion

Cloth face mask

EXPERIMENTAL

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

Other: Progressive cycling exercise test to exhaustion

Interventions

Progressive step cycling exercise test to exhaustion

Cloth face maskDisposable face maskNo face mask

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Experienced with cycling

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N5B2, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Philip Chilibeck, Ph.D.

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The individual who will statistically analyze the data will be blinded to condition
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 9, 2020

First Posted

September 21, 2020

Study Start

September 14, 2020

Primary Completion

October 15, 2020

Study Completion

October 15, 2020

Last Updated

October 20, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations