Healthy Young PeopleNCT04785378
The Effect of Use of Medical Masks on Exercise Capacity and Leg Endurance in Youth
A study testing Medical mask and Field tests in people with Healthy Young People, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Young People
- What is being tested?
- Medical mask and Field tests
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2021to 20 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.)
Who cannot join
- Presence of deformation in the face area that prevents the use of masks
- Individuals allergic to mask material
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acıbadem Mehmet Ali Aydınlar University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Ataşehir, Istanbul, 34750
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Young People
- Being tested
- Medical mask, Field tests
- Keywords
- exercise capacity, medical mask, lower extremity endurance, youth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical maskDevice
Participants will carry out field tests one day wearing a medical mask and the other day without a mask.
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 | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Not described Receives: Device: Medical mask; Other: Field tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minutes Walking Distance (6 DWD)
6 MWD means the distance traveled in 6 MWT. Its unit is meters.
Measured: 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.
Measured: 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.
Measured: Until the second field tests are completed, up to 10 days
Secondary outcomes (5)
Mask comfort level
It is the evaluation of each of the 10 sensations that can occur with the use of a mask with visual analog scale (VAS).
Measured: Until the second field tests are completed, up to 10 days
Dyspnea VAS score
It will be evaluated using VAS.
Measured: Until the second field tests are completed, up to 10 days
Dispnea modified borg scale (MBS) score
It will be evaluated MBS.
Measured: Until the second field tests are completed, up to 10 days
Fatigue VAS score
It will be evaluated using VAS.
Measured: Until the second field tests are completed, up to 10 days
Fatigue MBS score
It will be evaluated using MBS.
Measured: Until the second field tests are completed, up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start10 Feb 2021
- Primary completion20 Nov 2021
- Study completion20 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Healthy Young PeopleStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Collaborators
- Marmara University
- Responsible party
- Principal investigator, Meryem BEKTAŞ KARAKUŞ, Acibadem University
- Investigators
- Aysel Yıldız Özer, Assoc. prof., Study director, Marmara UniversityHızır Kurtel, Prof., Study director, Marmara UniversityMeryem Bektaş Karakuş, Principal investigator, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785378
- Sponsor's protocol ID
- 09.2021.39
- Status last verified
- Feb 2022
- First submitted
- 2 Mar 2021
- Last updated
- 23 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12091180Epstein 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.
PubMed 32969531Fikenzer 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.
PubMed 32632523Holland 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.
PubMed 25359355Li 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.
PubMed 15918037Person 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.
PubMed 29395560Shaw 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.
PubMed 33153145
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Use of Medical Masks on Exercise Capacity and Lower Extremity Endurance in Youth
- ClinicalTrials.gov ID
- NCT04785378
- Acronym / sponsor ID
- 09.2021.39
- Conditions
- Healthy Young People
- Keywords
- exercise capacity, medical mask, lower extremity endurance, youth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Collaborators
- Marmara University
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 20 Nov 2021 (actual)
- Study completion
- 20 Nov 2021 (actual)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Device: Medical mask, Other: Field tests |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.)
Key exclusion criteria (2 listed)
- Presence of deformation in the face area that prevents the use of masks
- Individuals allergic to mask material
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical maskParticipants will carry out field tests one day wearing a medical mask and the other day without a mask. | Device | Study Group |
| Field testsParticipants 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. | Other | Study Group |
Primary outcome
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.
5 secondary outcomes
Mask comfort level
Time frame: 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
Dispnea modified borg scale (MBS) score
Time frame: 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
Fatigue MBS score
Time frame: Until the second field tests are completed, up to 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Background: PubMed 12091180ATS 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.
- Background: PubMed 32969531Epstein 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.
- Background: PubMed 32632523Fikenzer 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.
- Background: PubMed 25359355Holland 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.
- Background: PubMed 15918037Li 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.
- Background: PubMed 29395560Person 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.
- Background: PubMed 33153145Shaw 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aysel Yıldız Özer, Assoc. prof. study director
Marmara University
Hızır Kurtel, Prof. study director
Marmara University
Meryem Bektaş Karakuş principal investigator
Acibadem University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical mask and Field tests in people with Healthy Young People, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Minutes Walking Distance (6 DWD) (time frame: Until the second field tests are completed, up to 10 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04785378, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2022.