NCT04874766

Brief Summary

There is concern that wearing a face mask during COVID will affect oxygen uptake, especially during intense exercise. COVID transmission is especially prevalent in sports such as hockey, where there is close contact between players and arena ventilation is poor. This study will assess the effect of wearing a surgical face mask on simulated hockey performance and 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
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

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

April 23, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 6, 2021

Completed
22 days until next milestone

Study Start

First participant enrolled

May 28, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

October 25, 2021

Status Verified

October 1, 2021

Enrollment Period

2 months

First QC Date

April 23, 2021

Last Update Submit

October 19, 2021

Conditions

Hypoxemia

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in average power output

    Average power output in Watts during two 20 second Wingate tests

    Up to 40 seconds

Secondary Outcomes (6)

  • Change from baseline in peak power output

    Up to 40 seconds

  • Change from baseline in on-ice sprint testing distance

    Up to 12 minutes

  • Change from baseline in blood oxygen saturation

    Up to 40 minutes

  • Change from baseline in quadriceps tissue oxygenation index

    Up to 40 minutes

  • Change from baseline in rating of perceived exertion

    Up to 40 minutes

  • +1 more secondary outcomes

Study Arms (2)

Surgical face mask

EXPERIMENTAL

Simulated hockey period with 2x20s Wingate tests; progressive-intensity on-ice sprint test while wearing a surgical mask

Other: Wingate exercise test and on-ice testing while wearing a face mask

Sham face mask

SHAM COMPARATOR

Simulated hockey period with 2x20s Wingate tests; progressive-intensity on-ice sprint test while wearing a sham mask

Other: Wingate exercise test and on-ice testing while wearing a sham face mask

Interventions

Wingate exercise test and on-ice testing while wearing a face maskOTHER

Power output during 2 x 20s Wingate cycle tests and total distance during an on-ice skating test while wearing a face mask

Surgical face mask
Wingate exercise test and on-ice testing while wearing a sham face maskOTHER

Power output during 2 x 20s Wingate cycle tests and total distance during an on-ice skating test while wearing a face mask

Sham face mask

Eligibility Criteria

Age9 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Experience playing ice-hockey

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 KA, Butcher S, Ko JB, Absher A, Gordon J, Tkachuk C, Zello GA, Chilibeck PD. Wearing a Surgical Face Mask Has Minimal Effect on Performance and Physiological Measures during High-Intensity Exercise in Youth Ice-Hockey Players: A Randomized Cross-Over Trial. Int J Environ Res Public Health. 2021 Oct 14;18(20):10766. doi: 10.3390/ijerph182010766.

    PMID: 34682512DERIVED

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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The participant will be blinded by wearing a sham mask during the "no mask" condition (i.e. they will wear a surgical mask with the covering for the mouth and nose cut out). The individual who will statistically analyze the data will be blinded to conditions
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 23, 2021

First Posted

May 6, 2021

Study Start

May 28, 2021

Primary Completion

July 15, 2021

Study Completion

August 31, 2021

Last Updated

October 25, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)