Impact of Facemasks on Running During COVID-19 Pandemic

Shortness of Breath Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04958863
• Other study ID #: 1718
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2021
• Source: Fundacion Clinica Valle del Lili
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 30, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Recreational runners.

• Age between 16-65 years.

• Workers or students from the health area.

Exclusion Criteria:

• None.

Related Conditions & MeSH terms

• Dyspnea
• Shortness of Breath

Intervention

Other:
• Surgical mask
Use of a surgical mask during test
• Polyester reusable mask
Use of a polyester reusable mask during test

Locations

Country	Name	City	State
Colombia	Fundación Valle del Lili	Cali	Valle

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Clinica Valle del Lili

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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