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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Mask | No Intervention | Runners do not use mask while running | |
| Surgical Mask | Experimental | Runners use surgical mask while running |
|
| Polyester Reusable Mask | Experimental | Runners use polyester reusable mask while running |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical mask | Other | Use of a surgical mask during test |
| |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan P Martinez, MD | Fundacion Clinica Valle del Lili | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundación Valle del Lili | Cali | Valle del Cauca Department | 760032 | Colombia |
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| ID | Term |
|---|---|
| D004417 | Dyspnea |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| Polyester reusable mask |
| Other |
Use of a polyester reusable mask during test |
|
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |