Back to resultsImpact of Facemasks on Running During COVID-19 Pandemic
Primary Purpose
Shortness of Breath
Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Surgical mask
Polyester reusable mask
Sponsored by
About this trial
This is an interventional other trial for Shortness of Breath focused on measuring Oxymetry, Shortness of Breath, Running, Masks, COVID-19
Eligibility Criteria
Inclusion Criteria:
- Recreational runners.
- Age between 16-65 years.
- Workers or students from the health area.
Exclusion Criteria:
- None.
Sites / Locations
- Fundación Valle del Lili
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
No Mask
Surgical Mask
Polyester Reusable Mask
Arm Description
Runners do not use mask while running
Runners use surgical mask while running
Runners use polyester reusable mask while running
Outcomes
Primary Outcome Measures
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
Oxygen saturation
The difference in the measured oxygen saturation with pulse oxymetry between groups at the end of the test
Heart rate
The difference in the measured heart rate with pulse oxymetry between groups at the end of the test
Secondary Outcome Measures
Full Information
NCT ID
NCT04958863
First Posted
June 30, 2021
Last Updated
July 9, 2021
Sponsor
Fundacion Clinica Valle del Lili
1. Study Identification
Unique Protocol Identification Number
NCT04958863
Brief Title
Impact of Facemasks on Running During COVID-19 Pandemic
Official Title
Running and Facemasks During COVID-19 Pandemic: a Randomized Crossover Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacion Clinica Valle del Lili
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shortness of Breath
Keywords
Oxymetry, Shortness of Breath, Running, Masks, COVID-19
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No Mask
Arm Type
No Intervention
Arm Description
Runners do not use mask while running
Arm Title
Surgical Mask
Arm Type
Experimental
Arm Description
Runners use surgical mask while running
Arm Title
Polyester Reusable Mask
Arm Type
Experimental
Arm Description
Runners use polyester reusable mask while running
Intervention Type
Other
Intervention Name(s)
Surgical mask
Intervention Description
Use of a surgical mask during test
Intervention Type
Other
Intervention Name(s)
Polyester reusable mask
Intervention Description
Use of a polyester reusable mask during test
Primary Outcome Measure Information:
Title
Shortness of breath in a visual analogue score (1-10)
Description
The difference in the subjective sensation of shortness of breath between groups at the end of the test
Time Frame
At the end of the 15-minutes test
Title
Oxygen saturation
Description
The difference in the measured oxygen saturation with pulse oxymetry between groups at the end of the test
Time Frame
At the end of the 15-minutes test
Title
Heart rate
Description
The difference in the measured heart rate with pulse oxymetry between groups at the end of the test
Time Frame
At the end of the 15-minutes test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Recreational runners.
Age between 16-65 years.
Workers or students from the health area.
Exclusion Criteria:
None.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan P Martinez, MD
Organizational Affiliation
Fundacion Clinica Valle del Lili
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundación Valle del Lili
City
Cali
State/Province
Valle
ZIP/Postal Code
760032
Country
Colombia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Facemasks on Running During COVID-19 Pandemic
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