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Clinical Trials/NCT04785378
NCT04785378CompletedNot Applicable

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

Acibadem University2 sites in 1 country79 target enrollmentStarted: February 10, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
79
Locations
2
Primary Endpoint
6 Minutes Walking Distance (6 DWD)

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 25 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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.

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.

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.

Secondary Outcomes

  • Fatigue VAS score(Until the second field tests are completed, up to 10 days)
  • Dispnea modified borg scale (MBS) score(Until the second field tests are completed, up to 10 days)
  • Mask comfort level(Until the second field tests are completed, up to 10 days)
  • Dyspnea VAS score(Until the second field tests are completed, up to 10 days)
  • Fatigue MBS score(Until the second field tests are completed, up to 10 days)

Investigators

Sponsor
Acibadem University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Meryem BEKTAŞ KARAKUŞ

Research Assistant

Acibadem University

Study Sites (2)

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