Impact of Facemasks on Running During COVID-19 Pandemic

NCT ID: NCT04958863

Last Updated: 2021-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-06-30

Brief Summary

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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

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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

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Shortness of Breath

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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No Mask

Runners do not use mask while running

Group Type NO_INTERVENTION

No interventions assigned to this group

Surgical Mask

Runners use surgical mask while running

Group Type EXPERIMENTAL

Surgical mask

Intervention Type OTHER

Use of a surgical mask during test

Polyester Reusable Mask

Runners use polyester reusable mask while running

Group Type EXPERIMENTAL

Polyester reusable mask

Intervention Type OTHER

Use of a polyester reusable mask during test

Interventions

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Surgical mask

Use of a surgical mask during test

Intervention Type OTHER

Polyester reusable mask

Use of a polyester reusable mask during test

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Recreational runners.
* Age between 16-65 years.
* Workers or students from the health area.

Exclusion Criteria

* None.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundacion Clinica Valle del Lili

OTHER

Sponsor Role lead

Responsible Party

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Juan Pablo Martinez

Orthopaedic surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juan P Martinez, MD

Role: PRINCIPAL_INVESTIGATOR

Fundacion Clinica Valle del Lili

Locations

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Fundación Valle del Lili

Cali, Valle del Cauca Department, Colombia

Site Status

Countries

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Colombia

Other Identifiers

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1718

Identifier Type: -

Identifier Source: org_study_id

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