Running and Facemasks During COVID-19 Pandemic: a Randomized Crossover Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- Shortness of breath in a visual analogue score (1-10)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Recreational runners.
- •Age between 16-65 years.
- •Workers or students from the health area.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
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
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Juan Pablo Martinez
Orthopaedic surgeon
Fundacion Clinica Valle del Lili