NCT04785378

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2021

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 2, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2021

Completed
Last Updated

February 23, 2022

Status Verified

February 1, 2022

Enrollment Period

9 months

First QC Date

March 2, 2021

Last Update Submit

February 22, 2022

Conditions

Healthy Young People

Keywords

exercise capacitymedical masklower extremity enduranceyouth

Outcome Measures

Primary Outcomes (3)

  • 6 Minutes Walking Distance (6 DWD)

    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

    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

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

    Until the second field tests are completed, up to 10 days

Secondary Outcomes (5)

  • 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

  • Dispnea modified borg scale (MBS) score

    Until the second field tests are completed, up to 10 days

  • Fatigue 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

Study Arms (1)

Study Group

EXPERIMENTAL
Device: Medical maskOther: Field tests

Interventions

Medical maskDEVICE

Participants will carry out field tests one day wearing a medical mask and the other day without a mask.

Study Group
Field testsOTHER

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.

Study Group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acıbadem Mehmet Ali Aydınlar University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Ataşehir, Istanbul, 34750, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

    PMID: 12091180BACKGROUND

  • 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.

    PMID: 32969531BACKGROUND

  • 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.

    PMID: 32632523BACKGROUND

  • 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.

    PMID: 25359355BACKGROUND

  • 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.

    PMID: 15918037BACKGROUND

  • 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.

    PMID: 29395560BACKGROUND

  • 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.

    PMID: 33153145BACKGROUND

Study Officials

  • Aysel Yıldız Özer, Assoc. prof.

    Marmara University

    STUDY DIRECTOR

  • Hızır Kurtel, Prof.

    Marmara University

    STUDY DIRECTOR

  • Meryem Bektaş Karakuş

    Acıbadem Mehmet Ali Aydınlar University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

March 2, 2021

First Posted

March 5, 2021

Study Start

February 10, 2021

Primary Completion

November 20, 2021

Study Completion

November 20, 2021

Last Updated

February 23, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)