Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634238
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Acute Mask Effects on Walk Distance and Vital Signs
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 050 ms and is incremented by 017 ms every minute until reaching a final speed of 237 ms 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 kgm² and no known diseases will be included in the study Individuals who self-report a history of chronic or acute diseasedysfunction 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 160100 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 v210 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 005
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 kgm² and no known diseases will be included in the study Individuals who self-report a history of chronic or acute diseasedysfunction 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 160100 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 v210 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 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None