Shortness of BreathNCT04958863
Impact of Facemasks on Running During COVID-19 Pandemic
A study testing Surgical mask and Polyester reusable mask in people with Shortness of Breath, run by Fundacion Clinica Valle del Lili at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Shortness of Breath
- What is being tested?
- Surgical mask and Polyester reusable mask
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteColombia
- Study dates
- 1 Jan 2021to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Recreational runners.
- Age between 16-65 years.
- Workers or students from the health area.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Fundación Valle del Lili
Cali, Valle del Cauca Department, 760032
About this study
Official title: 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.
Read the 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.
- Conditions
- Shortness of Breath
- Being tested
- Surgical mask, Polyester reusable mask
- Keywords
- Oxymetry, Shortness of Breath, Running, Masks, COVID-19
- Medical subject headings
- Dyspnea, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical maskOther
Use of a surgical mask during test
Polyester reusable maskOther
Use of a polyester reusable mask during test
| Study group | Role | What they receive |
|---|---|---|
| No Mask | No intervention | Runners do not use mask while running |
| Surgical Mask | Experimental | Runners use surgical mask while running Receives: Other: Surgical mask |
| Polyester Reusable Mask | Experimental | Runners use polyester reusable mask while running Receives: Other: Polyester reusable mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: At the end of the 15-minutes test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start1 Jan 2021
- Primary completion31 Mar 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shortness of BreathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinica Valle del Lili
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Pablo Martinez, Fundacion Clinica Valle del Lili
- Investigators
- Juan P Martinez, MD, Principal investigator, Fundacion Clinica Valle del Lili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958863
- Sponsor's protocol ID
- 1718
- Status last verified
- Jul 2021
- First submitted
- 30 Jun 2021
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Running and Facemasks During COVID-19 Pandemic: a Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT04958863
- Acronym / sponsor ID
- 1718
- Conditions
- Shortness of Breath
- Keywords
- Oxymetry, Shortness of Breath, Running, Masks, COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Fundacion Clinica Valle del LiliUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Mask | No intervention | –Runners do not use mask while running |
| Surgical Mask | Experimental | Other: Surgical maskRunners use surgical mask while running |
| Polyester Reusable Mask | Experimental | Other: Polyester reusable maskRunners use polyester reusable mask while running |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Recreational runners.
- Age between 16-65 years.
- Workers or students from the health area.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical maskUse of a surgical mask during test | Other | Surgical Mask |
| Polyester reusable maskUse of a polyester reusable mask during test | Other | Polyester Reusable Mask |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan P Martinez, MD principal investigator
Fundacion Clinica Valle del Lili
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical mask and Polyester reusable mask in people with Shortness of Breath, run by Fundacion Clinica Valle del Lili at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shortness of breath in a visual analogue score (1-10) (time frame: At the end of the 15-minutes test). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2021.