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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

79

Phase

  • 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

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
Intervention / Treatment
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

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

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

Acibadem University

Collaborators

Marmara University

Investigators

  • 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)

February 10, 2021

Primary Completion (Actual)

November 20, 2021

Study Completion (Actual)

November 20, 2021

Study Registration Dates

First Submitted

March 2, 2021

First Submitted That Met QC Criteria

March 4, 2021

First Posted (Actual)

March 5, 2021

Study Record Updates

Last Update Posted (Actual)

February 23, 2022

Last Update Submitted That Met QC Criteria

February 22, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID 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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