The Effect of Use of Medical Masks on Exercise Capacity and Leg Endurance in Youth

February 22, 2022 updated by: Meryem BEKTAŞ KARAKUŞ, Acibadem University

The Effect of Use of Medical Masks on Exercise Capacity and Lower Extremity Endurance in Youth

The use of masks has become an important part of life in outbreak conditions. In order to prevent the spread of the outbreak, many people in society may have to wear masks for hours during the day. As a mask type, the medical mask is frequently preferred in society. There are limited studies on how the use of medical masks affects the person wearing the mask while performing various activities that require different energy needs during the day. Therefore, this study aims to investigate how the use of medical mask affects exercise capacity and leg endurance with simple field tests.

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

Medical masks in use today are disposable and consist of three or four fine to very fine fibers. Medical masks are divided into three groups as type I, type II, and type IIR according to performance requirements. It is generally recommended for type I patients, type II, and type IIR healthcare professionals. The fact that many people in society use medical masks for hours in the current outbreak conditions and it is not known how long this situation will last suggests that the effects of the medical mask should be investigated further. This study was designed to investigate the effects use of a medical mask on exercise capacity and lower extremity endurance in young people. In the analysis using the G * Power 3.1.9.7 program, the sample size was calculated as 79 when the power ratio was at least 85% and the alpha error rate was 0.05. Participants included in the study will perform 3 field tests. Tests will be performed in the form of 30 seconds sit-to-stand test, incremental shuttle walk test (ISWT), and 6-minute walk test (6 MWT), respectively. Participants will come to the working place for 2 days to be evaluated. In this process, they will perform field tests one day with a medical mask and the other day without a mask. Whether the field tests to be performed on the first day will be with or without a medical mask will be decided through randomization. The tests to be made in the second visit will be carried out within 10 days with the time of the previous test, environmental conditions, and test sequence. The mask to be used in tests is a type I medical mask recommended for general public health in outbreak situations. The mask has three layers. During the study, the mask will be replaced with a new one at the end of each test. Also, mask-wearing comfort at rest, during daily living activities, and after ISWT will be evaluated with a 10-item scale. In the study, attention will be paid to precautions such as the researcher's use of a face shield and the protection of social distance in order to prevent the risk of contamination.

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.
79

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
    • İstanbul
      • Ataşehir, İstanbul, Turkey, 34750
        • Acıbadem Mehmet Ali Aydınlar University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

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 25 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Volunteering to participate in research
  • Not having any known acute/chronic diseases, especially respiratory, cardiac, and orthopedic pathologies
  • HES code suitability (The HES code provides information about the covid-19 status of the person and is compulsorily questioned at the entrance to the institution where the study will be conducted.)

Exclusion Criteria:

  • Presence of deformation in the face area that prevents the use of masks
  • Individuals allergic to mask material

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: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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: Study Group
Device: Medical mask
Participants will carry out field tests one day wearing a medical mask and the other day without a mask.
Other: Field tests
Participants will perform 6 MWT and ISWT tests to determine their exercise capacity, and a 30-second sit and stand test to determine lower extremity endurance.

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
6 Minutes Walking Distance (6 DWD)
Time Frame: Until the second field tests are completed, up to 10 days
6 MWD means the distance traveled in 6 MWT. Its unit is meters.
Until the second field tests are completed, up to 10 days
Distance traveled in ISWT
Time Frame: Until the second field tests are completed, up to 10 days
It means the distance traveled in ISWT. Its unit is meters.
Until the second field tests are completed, up to 10 days
30 seconds sit to stand test result
Time Frame: Until the second field tests are completed, up to 10 days
The result is the total number of stands within 30 seconds.
Until the second field tests are completed, up to 10 days

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
Mask comfort level
Time Frame: Until the second field tests are completed, up to 10 days
It is the evaluation of each of the 10 sensations that can occur with the use of a mask with visual analog scale (VAS).
Until the second field tests are completed, up to 10 days
Dyspnea VAS score
Time Frame: Until the second field tests are completed, up to 10 days
It will be evaluated using VAS.
Until the second field tests are completed, up to 10 days
Dispnea modified borg scale (MBS) score
Time Frame: Until the second field tests are completed, up to 10 days
It will be evaluated MBS.
Until the second field tests are completed, up to 10 days
Fatigue VAS score
Time Frame: Until the second field tests are completed, up to 10 days
It will be evaluated using VAS.
Until the second field tests are completed, up to 10 days
Fatigue MBS score
Time Frame: Until the second field tests are completed, up to 10 days
It will be evaluated using MBS.
Until the second field tests are completed, up to 10 days

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.
Acibadem University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Marmara University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Aysel Yıldız Özer, Assoc. prof., Marmara University
  • Study Director: Hızır Kurtel, Prof., Marmara University
  • Principal Investigator: Meryem Bektaş Karakuş, Acıbadem Mehmet Ali Aydınlar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
February 10, 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.
November 20, 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.
November 20, 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).
March 2, 2021

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 4, 2021

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 5, 2021

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.
February 23, 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.
February 22, 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.
February 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.
  • 09.2021.39

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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