Impact of Facemasks on Running During COVID-19 Pandemic

July 9, 2021 updated by: Juan Pablo Martinez, Fundacion Clinica Valle del Lili

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Valle
      • Cali, Valle, Colombia, 760032
        • Fundación Valle Del Lili

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shortness of breath in a visual analogue score (1-10)
Time Frame: 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
At the end of the 15-minutes test
Oxygen saturation
Time Frame: 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
At the end of the 15-minutes test
Heart rate
Time Frame: 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
At the end of the 15-minutes test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Clinica Valle del Lili

Investigators

  • Principal Investigator: Juan P Martinez, MD, Fundacion Clinica Valle del Lili

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

March 31, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

June 30, 2021

First Submitted That Met QC Criteria

July 9, 2021

First Posted (Actual)

July 12, 2021

Study Record Updates

Last Update Posted (Actual)

July 12, 2021

Last Update Submitted That Met QC Criteria

July 9, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1718

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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