HypoxemiaNCT04874766
The Effects of Wearing a Face Mask During Exercise in Youth Hockey Players During COVID-19
A study testing Wingate exercise test and on-ice testing while wearing a face mask in people with Hypoxemia, run by University of Saskatchewan at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxemia
- What is being tested?
- Wingate exercise test and on-ice testing while wearing a face mask
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 28 May 2021to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Experience playing ice-hockey
Who cannot join
- Contra-indications to exercise as identified by a screening questionnaire (the "Get Active Questionnaire")
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Wearing a Face Mask on Exercise Tolerance in Children's Hockey During the COVID-19 Pandemic
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.
Read the detailed description
The sport of ice hockey involves close contact between players in poorly ventilated arenas. This increases susceptibility for transmission of viruses, such as COVID-19. Face masks can reduce the risk of virus transmission; however, 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 a surgical face mask during exercise that simulates ice hockey play on exercise performance and blood and muscle oxygenation in boys and girls. Twelve boys and twelve girls (age 9-14y) who are experienced playing hockey, will take part in this randomized cross-over study that will assess exercise performance, blood oxygenation (i.e. pulse oximetry) and muscle oxygenation (with near infrared spectroscopy) during an exercise test on a cycle ergometer with workloads and work to rest intervals that simulates hockey performance. Participants will also be tested for repeated-sprint performance on ice while wearing full hockey equipment. The conditions include no mask (a "sham" mask) and a surgical mask. Outcome variables include power output during the cycle ergometer testing, skating distance during the on-ice test, rating of perceived exertion, blood oxygen saturation levels, and oxygenated, deoxygenated, and total hemoglobin at the quadriceps muscle.
- Conditions
- Hypoxemia
- Being tested
- Wingate exercise test and on-ice testing while wearing a face mask, Wingate exercise test and on-ice testing while wearing a sham face mask
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| Surgical face mask | Experimental | Simulated hockey period with 2x20s Wingate tests; progressive-intensity on-ice sprint test while wearing a surgical mask Receives: 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 Receives: Other: Wingate exercise test and on-ice testing while wearing a sham face mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in average power output
Average power output in Watts during two 20 second Wingate tests
Measured: Up to 40 seconds
Secondary outcomes (6)
Change from baseline in peak power output
Peak power output in Watts during two 20 second Wingate tests
Measured: Up to 40 seconds
Change from baseline in on-ice sprint testing distance
Distance in meters covered during a repeated 20-meter sprint test that progressively increases in speed
Measured: Up to 12 minutes
Change from baseline in blood oxygen saturation
Blood oxygen saturation (%) determined by pulse oximetry
Measured: Up to 40 minutes
Change from baseline in quadriceps tissue oxygenation index
Tissue oxygenation index (oxygenated hemoglobin/total hemoglobin) as measured by near infra-red spectroscopy
Measured: Up to 40 minutes
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
Measured: Up to 40 minutes
Change from baseline in heart rate
Heart rate (beats per minute)
Measured: Up to 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start28 May 2021
- Primary completion15 Jul 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypoxemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Saskatchewan Health Research Foundation
- Responsible party
- Principal investigator, Phil Chilibeck, University of Saskatchewan
- Investigators
- Philip Chilibeck, Ph.D., Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874766
- Sponsor's protocol ID
- 2701
- Status last verified
- Oct 2021
- First submitted
- 23 Apr 2021
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34682512
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Wearing a Face Mask on Exercise Tolerance in Children's Hockey During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04874766
- Acronym / sponsor ID
- 2701
- Conditions
- Hypoxemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Saskatchewan Health Research Foundation
- Study start
- 28 May 2021 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 6 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The sport of ice hockey involves close contact between players in poorly ventilated arenas. This increases susceptibility for transmission of viruses, such as COVID-19. Face masks can reduce the risk of virus transmission; however, 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 a surgical face mask during exercise that simulates ice hockey play on exercise performance and blood and muscle oxygenation in boys and girls. Twelve boys and twelve girls (age 9-14y) who are experienced playing hockey, will take part in this randomized cross-over study that will assess exercise performance, blood oxygenation (i.e. pulse oximetry) and muscle oxygenation (with near infrared spectroscopy) during an exercise test on a cycle ergometer with workloads and work to rest intervals that simulates hockey performance. Participants will also be tested for repeated-sprint performance on ice while wearing full hockey equipment. The conditions include no mask (a "sham" mask) and a surgical mask. Outcome variables include power output during the cycle ergometer testing, skating distance during the on-ice test, rating of perceived exertion, blood oxygen saturation levels, and oxygenated, deoxygenated, and total hemoglobin at the quadriceps muscle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical face mask | Experimental | Other: Wingate exercise test and on-ice testing while wearing a face maskSimulated hockey period with 2x20s Wingate tests; progressive-intensity on-ice sprint test while wearing a surgical mask |
| Sham face mask | Sham comparator | Other: Wingate exercise test and on-ice testing while wearing a sham face maskSimulated hockey period with 2x20s Wingate tests; progressive-intensity on-ice sprint test while wearing a sham mask |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Experience playing ice-hockey
Key exclusion criteria (1 listed)
- Contra-indications to exercise as identified by a screening questionnaire (the "Get Active Questionnaire")
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wingate exercise test and on-ice testing while wearing a face maskPower output during 2 x 20s Wingate cycle tests and total distance during an on-ice skating test while wearing a face mask | Other | Surgical face mask |
| Wingate exercise test and on-ice testing while wearing a sham face maskPower output during 2 x 20s Wingate cycle tests and total distance during an on-ice skating test while wearing a face mask | Other | Sham face mask |
Primary outcome
Change from baseline in average power output
Time frame: Up to 40 seconds
Average power output in Watts during two 20 second Wingate tests
6 secondary outcomes
Change from baseline in peak power output
Time frame: Up to 40 seconds
Change from baseline in on-ice sprint testing distance
Time frame: Up to 12 minutes
Change from baseline in blood oxygen saturation
Time frame: Up to 40 minutes
Change from baseline in quadriceps tissue oxygenation index
Time frame: Up to 40 minutes
Change from baseline in rating of perceived exertion
Time frame: Up to 40 minutes
Change from baseline in heart rate
Time frame: Up to 40 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Derived from this study: PubMed 34682512Shaw 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Chilibeck, Ph.D. principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wingate exercise test and on-ice testing while wearing a face mask in people with Hypoxemia, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in average power output (time frame: Up to 40 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04874766, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.