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

Sponsor
Acibadem University (Other)
Overall Status
Completed
CT.gov ID
NCT04785378
Collaborator
Marmara University (Other)
79
1
1
9.3
8.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Medical mask
  • Other: Field tests
N/A

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
Actual Enrollment :
79 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
The Effect of Use of Medical Masks on Exercise Capacity and Lower Extremity Endurance in Youth
Actual Study Start Date :
Feb 10, 2021
Actual Primary Completion Date :
Nov 20, 2021
Actual Study Completion Date :
Nov 20, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 6 Minutes Walking Distance (6 DWD) [Until the second field tests are completed, up to 10 days]

    6 MWD means the distance traveled in 6 MWT. Its unit is meters.

  2. Distance traveled in ISWT [Until the second field tests are completed, up to 10 days]

    It means the distance traveled in ISWT. Its unit is meters.

  3. 30 seconds sit to stand test result [Until the second field tests are completed, up to 10 days]

    The result is the total number of stands within 30 seconds.

Secondary Outcome Measures

  1. Mask comfort level [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).

  2. Dyspnea VAS score [Until the second field tests are completed, up to 10 days]

    It will be evaluated using VAS.

  3. Dispnea modified borg scale (MBS) score [Until the second field tests are completed, up to 10 days]

    It will be evaluated MBS.

  4. Fatigue VAS score [Until the second field tests are completed, up to 10 days]

    It will be evaluated using VAS.

  5. Fatigue MBS score [Until the second field tests are completed, up to 10 days]

    It will be evaluated using MBS.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 25 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Acıbadem Mehmet Ali Aydınlar University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation Ataşehir İstanbul Turkey 34750

Sponsors and Collaborators

  • Acibadem University
  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Meryem BEKTAŞ KARAKUŞ, Research Assistant, Acibadem University
ClinicalTrials.gov Identifier:
NCT04785378
Other Study ID Numbers:
  • 09.2021.39
First Posted:
Mar 5, 2021
Last Update Posted:
Feb 23, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Meryem BEKTAŞ KARAKUŞ, Research Assistant, Acibadem University

Study Results

No Results Posted as of Feb 23, 2022