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The Impact of Wearing Surgical and N-95 Masks During Maximal Exercise on Physiological, Perceptual, and Performance Responses in Healthy Men

Protocol summary

Study aim
Investigating the Impact of Wearing Surgical and N-95 Masks During the Shuttle Run Test on Physiological, Perceptual, and Performance Responses in Healthy Men
Design
Fifteen healthy young men completed the shuttle run test in three phases: without a mask, with a surgical mask, and with an N-95 mask, with one-week intervals between each phase. After each test, physiological variables, perceptual variables, and performance variables were measured.
Settings and conduct
The maximal exercise test, consisting of the 20-meter shuttle run test, was conducted one week after the familiarization phase and on separate days under three conditions: without a mask, with a surgical mask, and with an N-95 mask. Each condition was performed with one-week intervals, ensuring similar environmental and temporal conditions.
Participants/Inclusion and exclusion criteria
To select participants, an open call was made, inviting eligible individuals to participate in the study. Initially, 27 individuals expressed their willingness to participate. From this group, 15 participants were selected based on the inclusion criteria. The inclusion criteria included: age between 20-30 years, a body mass index (BMI) of 20-25 kg/m², absence of cardiovascular, metabolic, respiratory, and inflammatory diseases, as well as no regular participation in physical activities or smoking within 6 months prior to the study.
Intervention groups
The maximal exercise test included the 20-meter shuttle run test conducted under three conditions: without a mask, with a surgical mask, and with an N-95 mask.
Main outcome variables
Oxygen saturation, blood lactate concentration, rate of perceived exertion, maximum oxygen consumption, and the duration of the shuttle run test in healthy men were measured under both mask and no-mask conditions.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240906062961N1
Registration date: 2024-10-04, 1403/07/13
Registration timing: retrospective

Last update: 2024-10-04, 1403/07/13
Update count: 0
Registration date
2024-10-04, 1403/07/13
Registrant information
Name
Laleh Bagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3338 7358
Email address
lalehbagheri91@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-31, 1401/06/09
Expected recruitment end date
2022-10-01, 1401/07/09
Actual recruitment start date
2022-08-31, 1401/06/09
Actual recruitment end date
2022-10-01, 1401/07/09
Trial completion date
2022-10-02, 1401/07/10
Scientific title
The Impact of Wearing Surgical and N-95 Masks During Maximal Exercise on Physiological, Perceptual, and Performance Responses in Healthy Men
Public title
The Impact of Surgical and N95 Mask Use During Maximal Exercise
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20-30 years Body mass index 20-25 kg/m2 The absence of cardiovascular, metabolic, respiratory, and inflammatory diseases Lack of regular participation in physical activities No smoking for 6 months prior to the study
Exclusion criteria:
Existence of cardiovascular, metabolic, respiratory, inflammatory diseases Regular participation in sports activities Smoking in 6 months before the research
Age
From 20 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Actual sample size reached: 15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad University
Street address
Azad University Shaherkord Branch- Rahmatieh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733395
Approval date
2022-11-27, 1401/09/06
Ethics committee reference number
IR.IAU.SHK.REC.1401.096

Health conditions studied

1

Description of health condition studied
exercise in Covid-19
ICD-10 code
Y93.A9
ICD-10 code description
Activity, other involving cardiorespiratory exercise

Primary outcomes

1

Description
Physiological variables (heart rate, blood lactate concentration, and oxygen saturation), perceptual variables (feelings of comfort/discomfort and rate of perceived exertion), and performance variables (maximum oxygen consumption and duration of the shuttle run test) were assessed.
Timepoint
The shuttle run test was conducted in three phases: without a mask, with a surgical mask, and with an N-95 mask, with one-week intervals between each phase.
Method of measurement
Heart rate and oxygen saturation were measured before the start of the test and immediately after the shuttle run test using a portable finger pulse oximeter (Beurer model 80PO). Blood lactate concentration was assessed before the test and immediately after the shuttle run test. Capillary blood samples (approximately 1 microliter) were taken from the fingertips using a portable analyzer (Lactate Plus, Nova Biomedical, Waltham, Massachusetts).Perceptual variables, including the rate of perceived exertion, were evaluated using the Borg scale, which ranges from 6 to 20, where 6 indicates "no effort" and 20 indicates "maximum effort." Participants were asked to assess their level of effort at baseline and immediately after completing the shuttle run test during each trial.The comfort/discomfort scale required participants to indicate their level of comfort and discomfort using a visual analog scale from 0 to 10, with 0 meaning "not at all," 5 meaning "mild," and 10 meaning "severe." This scale included ten sections addressing breath resistance, feelings of tightness, discomfort, moisture, heat, odor, fatigue, itchiness, saltiness, and overall discomfort.Immediately after assessing the rate of perceived exertion following the shuttle run test with surgical and N-95 masks, participants were asked to share their thoughts on exercising with a mask during the trials.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group: One week before the start of the study, participants visited the university laboratory. Initially, resting heart rate, height, and weight were measured. Then, the participants were familiarized with the procedure of the shuttle run test, both with and without masks, as well as how to complete the Borg rate of perceived exertion questionnaire and the comfort/discomfort questionnaire. In this study, the maximal exercise test included the 20-meter shuttle run test, which was conducted one week after the familiarization phase and on separate days under three conditions: without a mask, with a surgical mask, and with an N-95 mask. Each condition was performed with one-week intervals, ensuring similar environmental and temporal conditions.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University Shahrekord Branch
Full name of responsible person
Akram Jafari
Street address
Chaharmahal and Bakhtiari Province, Shahr Kord،
City
Shahrekord
Province
South Khorasan
Postal code
8813733395
Phone
+98 38 3336 1024
Email
Shahrekord@iauece.ir
Web page address
Https://shahrekord.iau.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Akram Jafari
Street address
Chaharmahal and Bakhtiari Province, Shahrekord، Rahmatiyeh، 9W22+G7P
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733395
Phone
+98 38 3336 1024
Email
Shahrekord@iauece.ir
Web page address
Https://shahrekord.iau.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Akram Jafari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Chaharmahal and Bakhtiari Province, Shahrekord، Rahmatiyeh، 9W22+G7P
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733395
Phone
38333361024
Email
jafari.akm@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Akram Jafari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Chaharmahal and Bakhtiari Province, Shahr Kord، Rahmatiyeh، 9W22+G7P
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733395
Phone
+98 38 3336 1024
Email
Jafari.akm@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Akram Jafari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Chaharmahal and Bakhtiari Province, Shahr Kord، Rahmatiyeh، 9W22+G7P
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733395
Phone
+98 38 3336 1024
Email
Jafari.akm@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The results of the study included measurements such as oxygen saturation, blood lactate concentration, rate of perceived exertion, maximum oxygen consumption, and the duration of the shuttle run test. Additionally, factors such as feelings of moisture, heat, shortness of breath, and fatigue, as well as the average height and body mass index (BMI) of the participants, were also recorded.
When the data will become available and for how long
Six months after the publication of the results
To whom data/document is available
Researchers people
Under which criteria data/document could be used
For guidance and use in their subsequent research.
From where data/document is obtainable
Jafari.akm@gmail.com
What processes are involved for a request to access data/document
A week after receiving the email
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