Impact of Facemasks on Running During COVID-19 Pandemic

Not Applicable

Completed

• Conditions: Shortness of Breath

• Registration Number: NCT04958863
• Lead Sponsor: Fundacion Clinica Valle del Lili

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-03-31
• Study Completion: 2021-06-30
• Study First Submitted: 2021-06-30
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-09
• Last Update Submitted: 2021-07-09
• Study First Posted: 2021-07-12
• Last Update Posted: 2021-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Recreational runners.
• Age between 16-65 years.
• Workers or students from the health area.

Exclusion Criteria

• None.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Trial Locations

Locations (1)

Fundación Valle del Lili; 🇨🇴 Cali, Valle, Colombia