Clinical trial NCT04785378: The Effect of Use of Medical Masks on Exercise Capacity and Leg Endurance in Youth
Official title: The Effect of Use of Medical Masks on Exercise Capacity and Lower Extremity Endurance in Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Young People
Keywords: exercise capacity
medical mask
lower extremity endurance
youth
Lead sponsor: Acibadem University
Sponsor class: OTHER
Collaborators: name: Marmara University
First posted: 2021-03-05
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: 6 Minutes Walking Distance (6 DWD)
timeFrame: Until the second field tests are completed, up to 10 days
measure: Distance traveled in ISWT
timeFrame: Until the second field tests are completed, up to 10 days
measure: 30 seconds sit to stand test result
timeFrame: Until the second field tests are completed, up to 10 days
Secondary outcomes:
measure: Mask comfort level
timeFrame: Until the second field tests are completed, up to 10 days
measure: Dyspnea VAS score
timeFrame: Until the second field tests are completed, up to 10 days
measure: Dispnea modified borg scale (MBS) score
timeFrame: Until the second field tests are completed, up to 10 days
measure: Fatigue VAS score
timeFrame: Until the second field tests are completed, up to 10 days
measure: Fatigue MBS score
timeFrame: Until the second field tests are completed, up to 10 days
Other outcomes:
Locations:
city: Ataşehir
country: Turkey
facility: Acıbadem Mehmet Ali Aydınlar University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
state: İstanbul
Study officials:
affiliation: Marmara University
name: Aysel Yıldız Özer, Assoc. prof.
role: STUDY_DIRECTOR
affiliation: Marmara University
name: Hızır Kurtel, Prof.
role: STUDY_DIRECTOR
affiliation: Acıbadem Mehmet Ali Aydınlar University
name: Meryem Bektaş Karakuş
role: PRINCIPAL_INVESTIGATOR
References:
citation: ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
citation: Epstein D, Korytny A, Isenberg Y, Marcusohn E, Zukermann R, Bishop B, Minha S, Raz A, Miller A. Return to training in the COVID-19 era: The physiological effects of face masks during exercise. Scand J Med Sci Sports. 2021 Jan;31(1):70-75. doi: 10.1111/sms.13832. Epub 2020 Sep 30.
citation: Fikenzer S, Uhe T, Lavall D, Rudolph U, Falz R, Busse M, Hepp P, Laufs U. Effects of surgical and FFP2/N95 face masks on cardiopulmonary exercise capacity. Clin Res Cardiol. 2020 Dec;109(12):1522-1530. doi: 10.1007/s00392-020-01704-y. Epub 2020 Jul 6.
citation: Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.
citation: Li Y, Tokura H, Guo YP, Wong AS, Wong T, Chung J, Newton E. Effects of wearing N95 and surgical facemasks on heart rate, thermal stress and subjective sensations. Int Arch Occup Environ Health. 2005 Jul;78(6):501-9. doi: 10.1007/s00420-004-0584-4. Epub 2005 May 26.
citation: Person E, Lemercier C, Royer A, Reychler G. [Effect of a surgical mask on six minute walking distance]. Rev Mal Respir. 2018 Mar;35(3):264-268. doi: 10.1016/j.rmr.2017.01.010. Epub 2018 Feb 1. French.
citation: Shaw K, Butcher S, Ko J, Zello GA, Chilibeck PD. Wearing of Cloth or Disposable Surgical Face Masks has no Effect on Vigorous Exercise Performance in Healthy Individuals. Int J Environ Res Public Health. 2020 Nov 3;17(21):8110. doi: 10.3390/ijerph17218110.