Impact of Facemasks on Running During COVID-19 Pandemic

Sponsor
Fundacion Clinica Valle del Lili (Other)
Overall Status
Completed
CT.gov ID
NCT04958863
Collaborator
(none)
18
1
3
5.9
3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Surgical mask
  • Other: Polyester reusable mask
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Running and Facemasks During COVID-19 Pandemic: a Randomized Crossover Trial
Actual Study Start Date :
Jan 1, 2021
Actual Primary Completion Date :
Mar 31, 2021
Actual Study Completion Date :
Jun 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Recreational runners.

  • Age between 16-65 years.

  • Workers or students from the health area.

Exclusion Criteria:
  • None.

Contacts and Locations

Locations

Site City State Country Postal Code
1 FundaciĆ³n Valle del Lili Cali Valle Colombia 760032

Sponsors and Collaborators

  • Fundacion Clinica Valle del Lili

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Juan Pablo Martinez, Orthopaedic surgeon, Fundacion Clinica Valle del Lili
ClinicalTrials.gov Identifier:
NCT04958863
Other Study ID Numbers:
  • 1718
First Posted:
Jul 12, 2021
Last Update Posted:
Jul 12, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Juan Pablo Martinez, Orthopaedic surgeon, Fundacion Clinica Valle del Lili
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 12, 2021