Mask Usage ConditionNCT06634238
Acute Mask Effects on Walk Distance and Vital Signs
An observational study of Mask Usage Condition, run by Nagihan Acet.
Trial summary
The goal of this prospective observational study is to investigate the acute effects of mask use on walking distance and vital signs in healthy individuals aged 18-24 years. The main questions it aims to answer are: Does wearing a mask affect walking distance during the Incremental Shuttle Walk Test (ISWT)? How does… Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Mask Usage Condition
- What is being tested?
- Incremental shuttle walk test
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2024to 1 Mar 2025
- Phase
- Observational
- 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 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population consists of healthy volunteers, aged between 18 and 24 years, with a body mass index (BMI) of less than 30 kg/m². All participants are free from any known chronic or acute diseases, do not take prescription medications (except for oral contraception), and have no history of drug, alcohol, or cigarette use. Additionally, participants with blood pressure greater than 160/100 mmHg or those with known pregnancy status are excluded from the study.
Who may be able to join
- Individuals aged 18-24 years.
- Body mass index of less than 30 kg/m².
- No known diseases
Who cannot join
- Individuals with a self-reported history of chronic or acute disease/dysfunction that contraindicates or limits participation in exercise testing.
- Individuals taking prescription medications other than oral contraception.
- Those with known pregnancy status.
- Individuals who use drugs, cigarettes, or alcohol.
- Individuals with blood pressure greater than ≥160/100 mmHg.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: INVESTIGATION of the ACUTE EFFECT of MASK USE on WALKING DISTANCE and VITAL SIGNS DURING the INCREMENTAL SHUTTLE WALK TEST in HEALTHY INDIVIDUALS
The goal of this prospective observational study is to investigate the acute effects of mask use on walking distance and vital signs in healthy individuals aged 18-24 years. The main questions it aims to answer are:
Does wearing a mask affect walking distance during the Incremental Shuttle Walk Test (ISWT)? How does mask use influence heart rate, oxygen saturation, blood pressure, and respiratory rate during the test? Researchers will compare participants performing the ISWT with a mask to those performing it without a mask to determine any differences in walking distance and vital signs.
Read more
Participants will:
Complete the ISWT twice: once with a mask and once without a mask, on separate days.
Have their heart rate, oxygen saturation, respiratory rate, blood pressure, and dyspnea perception measured before and after each test.
Read the detailed description
The incremental shuttle walk test (ISWT) is an exercise test used to evaluate maximum exercise capacity in different chronic diseases. ISWT consists of 12 levels, each lasting 1 minute, where the participant walks back and forth along a 10-meter course. The test involves progressively increasing the pace as the individual moves between two cones placed 9 meters apart. The speed of walking is controlled by an audio signal. Initially, the speed is set at 0.50 m/s and is incremented by 0.17 m/s every minute until reaching a final speed of 2.37 m/s at level 12. The test concludes when the participant is hindered by shortness of breath or reaches a heart rate of 85% of their predicted maximum, or if they cannot sustain the required speed and fail to complete a shuttle for two consecutive attempts. The main result is determined by the distance traveled, which is calculated based on the number of shuttles completed.
The coronavirus pandemic has altered the manner in which routine tests are conducted. Since the beginning of the pandemic, wearing masks in public places has been mandatory, necessitating the use of masks during clinical tests.
There are a limited number of studies on the effects of mask use on the results of exercise tests. In a study investigating the effects of mask use on the results of the 6-minute walk test, no significant difference was found in terms of walking distance, while no significant difference was found in terms of dyspnea perception between the two groups. Similar results were found in another study on this subject.
To the best of our knowledge, there is no study in the literature examining the effect of mask use on the results of the ISWT. The aim of this study is to determine whether there are differences in walking distance, maximal heart rate, oxygen saturation, perception of dyspnea, and respiratory rate between healthy individuals undergoing the ISWT with and without masks.
Individuals aged 18-24 years with a body mass index of less than 30 kg/m² and no known diseases will be included in the study. Individuals who self-report a history of chronic or acute disease/dysfunction that contraindicates or limits participation in exercise testing, those taking prescription medications other than oral contraception, those with known pregnancy status, those using drugs, cigarettes, or alcohol, and those with blood pressure greater than or equal to 160/100 mmHg will be excluded from the study.
Participants will be recommended to wear comfortable clothing and appropriate shoes for the test. To minimize variability, each participant will perform the Incremental Shuttle Walk Test (ISWT) twice, once with a mask and once without a mask, at the same time of day on separate days. Walking distance, respiratory frequency, heart rate, dyspnea perception, and blood pressure will be measured at rest, immediately after the test, and one minute after the test.
Heart rate will be evaluated using a heart rate monitor (Polar FT 100), oxygen saturation will be measured with a portable pulse oximeter, blood pressure will be taken with a sphygmomanometer, respiratory frequency will be measured by counting the number of breaths per minute, and dyspnea perception will be assessed using the Modified Borg Scale.
The Modified Borg Scale is frequently used to evaluate the severity of dyspnea on exertion and at rest. It is a 10-point scale that defines the severity of dyspnea and is known to be a reliable scale for determining dyspnea severity and is related to respiratory function tests.
Statistical analysis will be performed using IBM Statistics SPSS v21.0 (IBM Corp., Armonk, NY, USA). Variables will be assessed using histograms and the Shapiro-Wilk test. For the primary and secondary outcomes, changes in ISWT with and without a mask, the Mann-Whitney U test will be used. Significance will be set at p < 0.05.
- Conditions
- Mask Usage Condition
- Being tested
- Incremental shuttle walk test
- Keywords
- Mask, vital signs, shuttle walk test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incremental shuttle walk testOther
Participants were recommended to wear comfortable clothing and appropriate shoes for the test. To minimize variability, one masked and one unmasked ISWT was performed on the same participant at the same time of day, one day apart
| Study group | Role | What they receive |
|---|---|---|
| Masked Group | Participants who performed the Incremental Shuttle Walk Test (ISWT) while wearing a face mask. Receives: Other: Incremental shuttle walk test | |
| Unmasked Group | Participants who performed the Incremental Shuttle Walk Test (ISWT) without wearing a face mask. Receives: Other: Incremental shuttle walk test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Heart rate will be evaluated using a heart rate monitor (Polar FT 100).
Measured: Before the test and immediately after the test
Oxygen saturation
Oxygen saturation will be evaluated with a portable pulse oximeter.
Measured: Before the test and immediately after the test
Blood pressure
Blood pressure will be evaluated by sphygmomanometer.
Measured: Before the test and immediately after the test
Respiratory frequency
Respiratory frequency will be evaluated by counting the number of breaths in a minute, and dyspnea perception was evaluated using the Modified Borg Scale.
Measured: Before the test and immediately after the test
Dyspnea perception
Dyspnea perception will be evaluated using the Modified Borg Scale.
Measured: Before the test and immediately after the test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start15 Oct 2024 (estimated)
- Primary completion15 Feb 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
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 Mask Usage ConditionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nagihan Acet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nagihan Acet, Atılım University
- Investigators
- Murat Esmer, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634238
- Sponsor's protocol ID
- GAZİ UNIVERSİTY
- Status last verified
- Oct 2024
- First submitted
- 8 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Singh SJ, Morgan MD, Scott S, Walters D, Hardman AE. Development of a shuttle walking test of disability in patients with chronic airways obstruction. Thorax. 1992 Dec;47(12):1019-24. doi: 10.1136/thx.47.12.1019.
PubMed 1494764Probst VS, Hernandes NA, Teixeira DC, Felcar JM, Mesquita RB, Goncalves CG, Hayashi D, Singh S, Pitta F. Reference values for the incremental shuttle walking test. Respir Med. 2012 Feb;106(2):243-8. doi: 10.1016/j.rmed.2011.07.023. Epub 2011 Aug 23.
PubMed 21865021Parreira VF, Janaudis-Ferreira T, Evans RA, Mathur S, Goldstein RS, Brooks D. Measurement properties of the incremental shuttle walk test. a systematic review. Chest. 2014 Jun;145(6):1357-1369. doi: 10.1378/chest.13-2071.
PubMed 24384555Burdon JG, Juniper EF, Killian KJ, Hargreave FE, Campbell EJ. The perception of breathlessness in asthma. Am Rev Respir Dis. 1982 Nov;126(5):825-8. doi: 10.1164/arrd.1982.126.5.825.
PubMed 7149447Grant S, Aitchison T, Henderson E, Christie J, Zare S, McMurray J, Dargie H. A comparison of the reproducibility and the sensitivity to change of visual analogue scales, Borg scales, and Likert scales in normal subjects during submaximal exercise. Chest. 1999 Nov;116(5):1208-17. doi: 10.1378/chest.116.5.1208.
PubMed 10559077Wu G, Sanderson B, Bittner V. The 6-minute walk test: how important is the learning effect? Am Heart J. 2003 Jul;146(1):129-33. doi: 10.1016/S0002-8703(03)00119-4.
PubMed 12851620Goncalves CG, Mesquita R, Hayashi D, Merli MF, Vidotto LS, Fernandes KB, Probst VS. Does the Incremental Shuttle Walking Test require maximal effort in healthy subjects of different ages? Physiotherapy. 2015 Jun;101(2):141-6. doi: 10.1016/j.physio.2014.11.002. Epub 2014 Nov 11.
PubMed 25700634
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INVESTIGATION of the ACUTE EFFECT of MASK USE on WALKING DISTANCE and VITAL SIGNS DURING the INCREMENTAL SHUTTLE WALK TEST in HEALTHY INDIVIDUALS
- ClinicalTrials.gov ID
- NCT06634238
- Acronym / sponsor ID
- GAZİ UNIVERSİTY
- Conditions
- Mask Usage Condition
- Keywords
- Mask, vital signs, shuttle walk test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nagihan AcetUniversity, hospital or other
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 15 Feb 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 9 Oct 2024 (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 goal of this prospective observational study is to investigate the acute effects of mask use on walking distance and vital signs in healthy individuals aged 18-24 years. The main questions it aims to answer are:
Does wearing a mask affect walking distance during the Incremental Shuttle Walk Test (ISWT)? How does mask use influence heart rate, oxygen saturation, blood pressure, and respiratory rate during the test? Researchers will compare participants performing the ISWT with a mask to those performing it without a mask to determine any differences in walking distance and vital signs.
Participants will:
Complete the ISWT twice: once with a mask and once without a mask, on separate days.
Have their heart rate, oxygen saturation, respiratory rate, blood pressure, and dyspnea perception measured before and after each test.
Detailed description
The incremental shuttle walk test (ISWT) is an exercise test used to evaluate maximum exercise capacity in different chronic diseases. ISWT consists of 12 levels, each lasting 1 minute, where the participant walks back and forth along a 10-meter course. The test involves progressively increasing the pace as the individual moves between two cones placed 9 meters apart. The speed of walking is controlled by an audio signal. Initially, the speed is set at 0.50 m/s and is incremented by 0.17 m/s every minute until reaching a final speed of 2.37 m/s at level 12. The test concludes when the participant is hindered by shortness of breath or reaches a heart rate of 85% of their predicted maximum, or if they cannot sustain the required speed and fail to complete a shuttle for two consecutive attempts. The main result is determined by the distance traveled, which is calculated based on the number of shuttles completed.
The coronavirus pandemic has altered the manner in which routine tests are conducted. Since the beginning of the pandemic, wearing masks in public places has been mandatory, necessitating the use of masks during clinical tests.
There are a limited number of studies on the effects of mask use on the results of exercise tests. In a study investigating the effects of mask use on the results of the 6-minute walk test, no significant difference was found in terms of walking distance, while no significant difference was found in terms of dyspnea perception between the two groups. Similar results were found in another study on this subject.
To the best of our knowledge, there is no study in the literature examining the effect of mask use on the results of the ISWT. The aim of this study is to determine whether there are differences in walking distance, maximal heart rate, oxygen saturation, perception of dyspnea, and respiratory rate between healthy individuals undergoing the ISWT with and without masks.
Individuals aged 18-24 years with a body mass index of less than 30 kg/m² and no known diseases will be included in the study. Individuals who self-report a history of chronic or acute disease/dysfunction that contraindicates or limits participation in exercise testing, those taking prescription medications other than oral contraception, those with known pregnancy status, those using drugs, cigarettes, or alcohol, and those with blood pressure greater than or equal to 160/100 mmHg will be excluded from the study.
Participants will be recommended to wear comfortable clothing and appropriate shoes for the test. To minimize variability, each participant will perform the Incremental Shuttle Walk Test (ISWT) twice, once with a mask and once without a mask, at the same time of day on separate days. Walking distance, respiratory frequency, heart rate, dyspnea perception, and blood pressure will be measured at rest, immediately after the test, and one minute after the test.
Heart rate will be evaluated using a heart rate monitor (Polar FT 100), oxygen saturation will be measured with a portable pulse oximeter, blood pressure will be taken with a sphygmomanometer, respiratory frequency will be measured by counting the number of breaths per minute, and dyspnea perception will be assessed using the Modified Borg Scale.
The Modified Borg Scale is frequently used to evaluate the severity of dyspnea on exertion and at rest. It is a 10-point scale that defines the severity of dyspnea and is known to be a reliable scale for determining dyspnea severity and is related to respiratory function tests.
Statistical analysis will be performed using IBM Statistics SPSS v21.0 (IBM Corp., Armonk, NY, USA). Variables will be assessed using histograms and the Shapiro-Wilk test. For the primary and secondary outcomes, changes in ISWT with and without a mask, the Mann-Whitney U test will be used. Significance will be set at p < 0.05.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Masked Group | – | Other: Incremental shuttle walk testParticipants who performed the Incremental Shuttle Walk Test (ISWT) while wearing a face mask. |
| Unmasked Group | – | Other: Incremental shuttle walk testParticipants who performed the Incremental Shuttle Walk Test (ISWT) without wearing a face mask. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population consists of healthy volunteers, aged between 18 and 24 years, with a body mass index (BMI) of less than 30 kg/m². All participants are free from any known chronic or acute diseases, do not take prescription medications (except for oral contraception), and have no history of drug, alcohol, or cigarette use. Additionally, participants with blood pressure greater than 160/100 mmHg or those with known pregnancy status are excluded from the study.
Key inclusion criteria (3 listed)
- Individuals aged 18-24 years.
- Body mass index of less than 30 kg/m².
- No known diseases
Key exclusion criteria (5 listed)
- Individuals with a self-reported history of chronic or acute disease/dysfunction that contraindicates or limits participation in exercise testing.
- Individuals taking prescription medications other than oral contraception.
- Those with known pregnancy status.
- Individuals who use drugs, cigarettes, or alcohol.
- Individuals with blood pressure greater than ≥160/100 mmHg.
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 |
|---|---|---|
| Incremental shuttle walk testParticipants were recommended to wear comfortable clothing and appropriate shoes for the test. To minimize variability, one masked and one unmasked ISWT was performed on the same participant at the same time of day, one day apart | Other | Masked Group, Unmasked Group |
Primary outcome
Heart rate
Time frame: Before the test and immediately after the test
Heart rate will be evaluated using a heart rate monitor (Polar FT 100).
Oxygen saturation
Time frame: Before the test and immediately after the test
Oxygen saturation will be evaluated with a portable pulse oximeter.
Blood pressure
Time frame: Before the test and immediately after the test
Blood pressure will be evaluated by sphygmomanometer.
Respiratory frequency
Time frame: Before the test and immediately after the test
Respiratory frequency will be evaluated by counting the number of breaths in a minute, and dyspnea perception was evaluated using the Modified Borg Scale.
Dyspnea perception
Time frame: Before the test and immediately after the test
Dyspnea perception will be evaluated using the Modified Borg Scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Background: PubMed 1494764Singh SJ, Morgan MD, Scott S, Walters D, Hardman AE. Development of a shuttle walking test of disability in patients with chronic airways obstruction. Thorax. 1992 Dec;47(12):1019-24. doi: 10.1136/thx.47.12.1019.
- Background: PubMed 21865021Probst VS, Hernandes NA, Teixeira DC, Felcar JM, Mesquita RB, Goncalves CG, Hayashi D, Singh S, Pitta F. Reference values for the incremental shuttle walking test. Respir Med. 2012 Feb;106(2):243-8. doi: 10.1016/j.rmed.2011.07.023. Epub 2011 Aug 23.
- Background: PubMed 24384555Parreira VF, Janaudis-Ferreira T, Evans RA, Mathur S, Goldstein RS, Brooks D. Measurement properties of the incremental shuttle walk test. a systematic review. Chest. 2014 Jun;145(6):1357-1369. doi: 10.1378/chest.13-2071.
- Background: PubMed 7149447Burdon JG, Juniper EF, Killian KJ, Hargreave FE, Campbell EJ. The perception of breathlessness in asthma. Am Rev Respir Dis. 1982 Nov;126(5):825-8. doi: 10.1164/arrd.1982.126.5.825.
- Background: PubMed 10559077Grant S, Aitchison T, Henderson E, Christie J, Zare S, McMurray J, Dargie H. A comparison of the reproducibility and the sensitivity to change of visual analogue scales, Borg scales, and Likert scales in normal subjects during submaximal exercise. Chest. 1999 Nov;116(5):1208-17. doi: 10.1378/chest.116.5.1208.
- Background: PubMed 12851620Wu G, Sanderson B, Bittner V. The 6-minute walk test: how important is the learning effect? Am Heart J. 2003 Jul;146(1):129-33. doi: 10.1016/S0002-8703(03)00119-4.
- Background: PubMed 25700634Goncalves CG, Mesquita R, Hayashi D, Merli MF, Vidotto LS, Fernandes KB, Probst VS. Does the Incremental Shuttle Walking Test require maximal effort in healthy subjects of different ages? Physiotherapy. 2015 Jun;101(2):141-6. doi: 10.1016/j.physio.2014.11.002. Epub 2014 Nov 11.
- Individual participant dataSharing planned: Undecided
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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.
Murat Esmer principal investigator
Gazi University
Questions about this trial
What is this clinical trial studying?
An observational study of Mask Usage Condition, run by Nagihan Acet.
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 5 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: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nagihan Acet, Phd. (05322052605 ext. +90, nagihan.acet@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: Before the test and immediately after the test). The study lists 5 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 NCT06634238, 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 15 Oct 2024.