Impact of Facemasks on Running During COVID-19 Pandemic
Running and Facemasks During COVID-19 Pandemic: a Randomized Crossover Trial
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedFirst Submitted
Initial submission to the registry
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedFirst Posted
Study publicly available on registry
July 12, 2021
CompletedJuly 12, 2021
July 1, 2021
3 months
June 30, 2021
July 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (3)
No Mask
NO INTERVENTIONRunners do not use mask while running
Surgical Mask
EXPERIMENTALRunners use surgical mask while running
Polyester Reusable Mask
EXPERIMENTALRunners use polyester reusable mask while running
Interventions
Eligibility Criteria
You may qualify if:
- Recreational runners.
- Age between 16-65 years.
- Workers or students from the health area.
You may not qualify if:
- None.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fundación Valle del Lili
Cali, Valle del Cauca Department, 760032, Colombia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juan P Martinez, MD
Fundacion Clinica Valle del Lili
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Orthopaedic surgeon
Study Record Dates
First Submitted
June 30, 2021
First Posted
July 12, 2021
Study Start
January 1, 2021
Primary Completion
March 31, 2021
Study Completion
June 30, 2021
Last Updated
July 12, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share