Impact of Facemasks on Running During COVID-19 Pandemic

Study Overview
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Brief Summary
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Randomized crossover clinical trial in which a group of runners are ask to complete a 15 minutes standardized physical test on a treadmill. The same group of participants are randomized to the order in which they use a facemask (surgical mask, polyester reusable cloth mask) or no mask, while running. Each test, according to the type of mask or no mask, are held on different dates. Heart rate, oxygen saturation and shortness of breath are measured every 3 minutes during the test.

Detailed Description
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Between 15-20 recreational runners are included in a crossover trial to run under three different conditions the same 15-minutes treadmill running test. They Will run wtih surgical mask, polyester reusable cloth mask or without mask. The order in which they use or not the mask is randomized. Each test is done on a different day. Heart rate, oxygen saturation and shortness of breath are measured every 3 minutes during the test. The primary outcomes are the differences in heart rate, oxygen saturation and shortness of breath at the end of the test, between groups.

Official Title
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Running and Facemasks During COVID-19 Pandemic: a Randomized Crossover Trial

Conditions
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Shortness of Breath

Intervention / Treatment
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* Other: Surgical mask
* Other: Polyester reusable mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recreational runners. Age between 16-65 years. Workers or students from the health area. Exclusion Criteria: None.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Mask<br>Runners do not use mask while running | |
| Experimental: Surgical Mask<br>Runners use surgical mask while running | Other: Surgical mask<br>* Use of a surgical mask during test<br>|
| Experimental: Polyester Reusable Mask<br>Runners use polyester reusable mask while running | Other: Polyester reusable mask<br>* Use of a polyester reusable mask during test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shortness of breath in a visual analogue score (1-10) | The difference in the subjective sensation of shortness of breath between groups at the end of the test | At the end of the 15-minutes test | 
| Oxygen saturation | The difference in the measured oxygen saturation with pulse oxymetry between groups at the end of the test | At the end of the 15-minutes test | 
| Heart rate | The difference in the measured heart rate with pulse oxymetry between groups at the end of the test | At the end of the 15-minutes test | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxymetry, Shortness of Breath, Running, Masks, COVID-19