Exercising With a Surgical Mask in Both Athletic and Non-athletic Individuals

March 8, 2022 updated by: Şensu Dinçer

Exercising With a Surgical Mask is Safe But Decreases Performance in Both Athletic and Non-athletic Individuals

This study aimed to examine the impact of surgical masks on maximal and submaximal exercise in both athlete and non-athlete individuals.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

All participants will be informed about the procedure and, will sign an informed consent form. They will undergone a detailed physical examination before enrollment in the study. The study is conducted in 2-phases, in non-randomized, controlled design. Cardiopulmonary exercise tests (CPET) are going to be performed with and without a surgical mask with 48 hours in between.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34093
        • Şensu Dinçer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy athletes
  • healthy non-athletes

Exclusion Criteria:

  • any musculoskeletal, cardiac or respiratory problem

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: with surgical mask
all participants who were applied CPET with surgical mask
Diagnostic test: CPET with mask
A 3-layer surgical mask was placed on CPET device's mask and was fixed with a CPET tribune. In phase 2, as using this combined (surgical mask and device's mask) masks, CPETs were performed in all participants again, after 48 hours.
Active Comparator: without surgical mask
all participants who were applied CPET without surgical mask
Diagnostic test: CPET without mask
Regular cardiopulmonary exercise tests were applied to all participants in phase 1.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
maximum oxygen consumption (VO2max) change between CPET with surgical mask and without surgical mask
Time Frame: two CPET tests which will be carried out two days within 2 weeks
Cardiopulmonary exercise test (CPET) is a well known, gold standard test to measure VO2 max during exercise. The higher VO2 max value shows better endurance.VO₂ max is the maximum (max) rate (V) of oxygen (O₂) the body is able to use during exercise
two CPET tests which will be carried out two days within 2 weeks
max minute ventilation (VEmax) change between CPET with surgical mask and without surgical mask
Time Frame: two CPET tests which will be carried out two days within 2 weeks
VEmax is the maximum volume of gas inhaled (inhaled minute volume) or exhaled (exhaled minute volume) from a person's lungs per minute.
two CPET tests which will be carried out two days within 2 weeks
exercise test duration change between CPET with surgical mask and without surgical mask
Time Frame: two CPET tests which will be carried out two days within 2 weeks
CPET duration of a participant
two CPET tests which will be carried out two days within 2 weeks
end-tidal carbon dioxide pressure (pETCO2) change at the maximum and anaerobic levels of CPET
Time Frame: two CPET tests which will be carried out two days within 2 weeks
End-tidal carbon dioxide pressure (pETCO2) is the level of carbon dioxide that is released at the end of an exhaled breath.
two CPET tests which will be carried out two days within 2 weeks
End-tidal partial oxygen pressure (pETO2) change at the maximum and anaerobic levels of CPET
Time Frame: two CPET tests which will be carried out two days within 2 weeks
refers to PO2 of exhaled gas. It is measured at the end of exhalation and its units are mm Hg.
two CPET tests which will be carried out two days within 2 weeks
Tidal volume (TV) change at the maximum and anaerobic levels of CPET
Time Frame: two CPET tests which will be carried out two days within 2 weeks
TV that volume of air moved into or out of the lungs during quiet breathing
two CPET tests which will be carried out two days within 2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
minute ventilation at anerobic level (VEan) results of athlete and non-athlete comparison
Time Frame: 2 weeks
The VEan difference in between the changes in CPETs with and without masks of athletes and non-athletes
2 weeks
maximum minute ventilation (VEmax) results of athlete and non-athlete comparison
Time Frame: 2 weeks
The VEmax difference in between the changes in CPETs with and without masks of athletes and non-athletes
2 weeks
VO2max results of athlete and non-athlete comparison
Time Frame: 2 weeks
The VO2max difference in between the changes in CPETs with and without masks of athletes and non-athletes
2 weeks
VO2an results of athlete and non-athlete comparison
Time Frame: 2 weeks
The VO2an difference in between the changes in CPETs with and without masks of athletes and non-athletes
2 weeks
PETO2 results of athlete and non-athlete comparison
Time Frame: 2 weeks
The PETO2 difference in between the changes in CPETs with and without masks of athletes and non-athletes
2 weeks
PETCO2
Time Frame: 2 weeks
The PETCO2 difference in between the changes in CPETs with and without masks of athletes and non-athletes
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Şensu Dinçer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 16, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 7, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 7, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Exercising with a mask

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All individual participant data (IPD)that will underlie results

IPD Sharing Time Frame

starting 1 year after publication

IPD Sharing Access Criteria

IPD can be shared by researchers such as exercise physiologists, sports scientist and sport medicine physicians

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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