Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04789603
Status:
UNKNOWN
Last Update Posted:
2021-05-11
First Post:
2021-03-04
Brief Title:
Effects of Using Mask During the 6-minute Walking Test in Times of COVID-19
Sponsor:
Universitat Internacional de Catalunya
Organization:
Universitat Internacional de Catalunya
Study Overview
Official Title:
Effects of Using the Surgical Mask and FFp2 in the Distance Walked Heart Rate Oxygenometry and Tone of the Accessory Inspiratory Muscles During the 6-minute Walking Test
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Since the beginning of the pandemic caused by SARC-CoV 2 more than 81 million cases have been diagnosed and caused around 17 million deaths Currently a drug is being sought for the treatment of coronavirus The worldwide effort to create an effective and safe COVID-19 vaccine is beginning to yield results Several vaccines now have been authorized around the globe many more remain in development Nonetheless in the absence of effective pharmacological treatment and given the viruss transmission capacity different alternatives have been proposed to stop the transmission of the virus Therefore these preventive measures against transmission are expected to remain in force for some time
The transmission of the virus occurs from person-to-person different studies conclude that transmission occurs by aerosols from respiratory droplets The optimal distance between people to stop person-to-person transmission is uncertain For this reason and given that there is no effective drug transmission prevention is of great importance especially for pandemic mitigation in community settings
The World Health Organization WHO established simple precautions to prevent the spread of the virus such as physical distancing wearing a mask keeping rooms well ventilated avoiding crowds cleaning your hands and coughing into a bent elbow or tissue For this reason the use of the mask has been proposed in several countries being mandatory in many of them for use in the health environment and daily use
The WHO recommends different types of masks depending on the person where it will be used or the population incidence in the area Wearing a medical surgical mask is recommended for people over 60 those who have underlying medical conditions feel unwell andor look after an ill family member For health workers respirator masks such as FFP2 FFP3 N95 N99 should be used in settings where procedures are generating aerosols
The use of a mask could imply an inspiratory and expiratory restraint and generate a feeling of discomfort in many people It is responsible for an increase in the inspiratory and expiratory pressures generated This feeling of discomfort and the increment of pressures causes shallow and forced breathing and increases the respiratory accessory musculature activation
Person et al observed that the subjects who used a mask felt dyspnea clinically and significantly higher than those who did not use it However to our knowledge no study has analyzed the parameters of physical effort respiratory parameters self-perceived dyspnea and muscle activation using different types of masks in healthy subjects For this reason the present study hypothesis is that there are no changes between wearing and not-wearing a mask surgical or N-95 in the effort and ventilatory parameters even though there may be an increase in the tone of the cervical muscles or the perception of dyspnea using a face mask
This study aims to observe the effect that the surgical mask and the N-95 mask have in the distance walked in the oxygenometry in the heart rate in the sensation of dyspnea and the tone of the inspiratory accessory muscles during the 6 minutes walking test
Procedure After verifying that the subjects meet the inclusion criteria and sign the consent they will be given a registration number An investigator will observe the number in a random list and included the participant in one of the three groups without a mask with a surgical mask and with N95 mask This researcher will make an initial registration of demographic data gender age weight height cardiorespiratory pathology smoker number of cigarettes per day a sport performed hours of daily sport and days of sport per week Before the test all the subjects will have to remain for 30 minutes without a mask breathing normally This phase will be called the resting phase Subsequently the subjects will go to the area where the 6MWT will be carried out Each one of them will be performed the test according to the group to which they will be assigned An investigator blinded to the subsequent assessment will encourage the participants to take the 6MWT according to the recommendations mentioned above After performing the 6MWT all subjects will go to the assessment area All the subjects will wear a surgical mask so that the researcher can not know to which group they have been assigned Besides this researcher will not have access to the registration number or the 6-minute walking test area
At the end of each resting phase SpO2 and baseline HR will be recorded After every 6MWT the HR SpO2 and self-perceived dyspnea will be recorded The muscle tone will also be assessed with the MyotonPRO in middle scalene and SCM
Subjects will have the option of retaking the test going through all the phases mentioned above
The transmission of the virus occurs from person-to-person different studies conclude that transmission occurs by aerosols from respiratory droplets The optimal distance between people to stop person-to-person transmission is uncertain For this reason and given that there is no effective drug transmission prevention is of great importance especially for pandemic mitigation in community settings
The World Health Organization WHO established simple precautions to prevent the spread of the virus such as physical distancing wearing a mask keeping rooms well ventilated avoiding crowds cleaning your hands and coughing into a bent elbow or tissue For this reason the use of the mask has been proposed in several countries being mandatory in many of them for use in the health environment and daily use
The WHO recommends different types of masks depending on the person where it will be used or the population incidence in the area Wearing a medical surgical mask is recommended for people over 60 those who have underlying medical conditions feel unwell andor look after an ill family member For health workers respirator masks such as FFP2 FFP3 N95 N99 should be used in settings where procedures are generating aerosols
The use of a mask could imply an inspiratory and expiratory restraint and generate a feeling of discomfort in many people It is responsible for an increase in the inspiratory and expiratory pressures generated This feeling of discomfort and the increment of pressures causes shallow and forced breathing and increases the respiratory accessory musculature activation
Person et al observed that the subjects who used a mask felt dyspnea clinically and significantly higher than those who did not use it However to our knowledge no study has analyzed the parameters of physical effort respiratory parameters self-perceived dyspnea and muscle activation using different types of masks in healthy subjects For this reason the present study hypothesis is that there are no changes between wearing and not-wearing a mask surgical or N-95 in the effort and ventilatory parameters even though there may be an increase in the tone of the cervical muscles or the perception of dyspnea using a face mask
This study aims to observe the effect that the surgical mask and the N-95 mask have in the distance walked in the oxygenometry in the heart rate in the sensation of dyspnea and the tone of the inspiratory accessory muscles during the 6 minutes walking test
Procedure After verifying that the subjects meet the inclusion criteria and sign the consent they will be given a registration number An investigator will observe the number in a random list and included the participant in one of the three groups without a mask with a surgical mask and with N95 mask This researcher will make an initial registration of demographic data gender age weight height cardiorespiratory pathology smoker number of cigarettes per day a sport performed hours of daily sport and days of sport per week Before the test all the subjects will have to remain for 30 minutes without a mask breathing normally This phase will be called the resting phase Subsequently the subjects will go to the area where the 6MWT will be carried out Each one of them will be performed the test according to the group to which they will be assigned An investigator blinded to the subsequent assessment will encourage the participants to take the 6MWT according to the recommendations mentioned above After performing the 6MWT all subjects will go to the assessment area All the subjects will wear a surgical mask so that the researcher can not know to which group they have been assigned Besides this researcher will not have access to the registration number or the 6-minute walking test area
At the end of each resting phase SpO2 and baseline HR will be recorded After every 6MWT the HR SpO2 and self-perceived dyspnea will be recorded The muscle tone will also be assessed with the MyotonPRO in middle scalene and SCM
Subjects will have the option of retaking the test going through all the phases mentioned above
Detailed Description:
Since the beginning of the pandemic caused by SARC-CoV 2 more than 81 million cases have been diagnosed and caused around 17 million deaths Currently a drug is being sought for the treatment of coronavirus The worldwide effort to create an effective and safe COVID-19 vaccine is beginning to yield results Several vaccines now have been authorized around the globe many more remain in development Nonetheless in the absence of effective pharmacological treatment and given the viruss transmission capacity different alternatives have been proposed to stop the transmission of the virus Therefore these preventive measures against transmission are expected to remain in force for some time
The transmission of the virus occurs from person-to-person different studies conclude that transmission occurs by aerosols from respiratory droplets The optimal distance between people to stop person-to-person transmission is uncertain For this reason and given that there is no effective drug transmission prevention is of great importance especially for pandemic mitigation in community settings
The World Health Organization WHO established simple precautions to prevent the spread of the virus such as physical distancing wearing a mask keeping rooms well ventilated avoiding crowds cleaning your hands and coughing into a bent elbow or tissue For this reason the use of the mask has been proposed in several countries being mandatory in many of them for use in the health environment and daily use
The WHO recommends different types of masks depending on the person where it will be used or the population incidence in the area Wearing a medical surgical mask is recommended for people over 60 those who have underlying medical conditions feel unwell andor look after an ill family member For health workers respirator masks such as FFP2 FFP3 N95 N99 should be used in settings where procedures are generating aerosols
The use of a mask could imply an inspiratory and expiratory restraint and generate a feeling of discomfort in many people It is responsible for an increase in the inspiratory and expiratory pressures generated This feeling of discomfort and the increment of pressures causes shallow and forced breathing and increases the respiratory accessory musculature activation
Person et al observed that the subjects who used a mask felt dyspnea clinically and significantly higher than those who did not use it However to our knowledge no study has analyzed the parameters of physical effort respiratory parameters self-perceived dyspnea and muscle activation using different types of masks in healthy subjects For this reason the present study hypothesis is that there are no changes between wearing and not-wearing a mask surgical or N-95 in the effort and ventilatory parameters even though there may be an increase in the tone of the cervical muscles or the perception of dyspnea using a face mask
This study aims to observe the effect that the surgical mask and the N-95 mask have in the distance walked in the oxygenometry in the heart rate in the sensation of dyspnea and the tone of the inspiratory accessory muscles during the 6 minutes walking test
Procedure After verifying that the subjects meet the inclusion criteria and sign the consent they will be given a registration number An investigator will observe the number in a random list and included the participant in one of the three groups without a mask with a surgical mask and with N95 mask This researcher will make an initial registration of demographic data gender age weight height cardiorespiratory pathology smoker number of cigarettes per day a sport performed hours of daily sport and days of sport per week Before the test all the subjects will have to remain for 30 minutes without a mask breathing normally This phase will be called the resting phase Subsequently the subjects will go to the area where the 6MWT will be carried out Each one of them will be performed the test according to the group to which they will be assigned An investigator blinded to the subsequent assessment will encourage the participants to take the 6MWT according to the recommendations mentioned above After performing the 6MWT all subjects will go to the assessment area All the subjects will wear a surgical mask so that the researcher can not know to which group they have been assigned Besides this researcher will not have access to the registration number or the 6-minute walking test area
At the end of each resting phase SpO2 and baseline HR will be recorded After every 6MWT the HR SpO2 and self-perceived dyspnea will be recorded The muscle tone will also be assessed with the MyotonPRO in middle scalene and SCM
Subjects will have the option of retaking the test going through all the phases mentioned above
The transmission of the virus occurs from person-to-person different studies conclude that transmission occurs by aerosols from respiratory droplets The optimal distance between people to stop person-to-person transmission is uncertain For this reason and given that there is no effective drug transmission prevention is of great importance especially for pandemic mitigation in community settings
The World Health Organization WHO established simple precautions to prevent the spread of the virus such as physical distancing wearing a mask keeping rooms well ventilated avoiding crowds cleaning your hands and coughing into a bent elbow or tissue For this reason the use of the mask has been proposed in several countries being mandatory in many of them for use in the health environment and daily use
The WHO recommends different types of masks depending on the person where it will be used or the population incidence in the area Wearing a medical surgical mask is recommended for people over 60 those who have underlying medical conditions feel unwell andor look after an ill family member For health workers respirator masks such as FFP2 FFP3 N95 N99 should be used in settings where procedures are generating aerosols
The use of a mask could imply an inspiratory and expiratory restraint and generate a feeling of discomfort in many people It is responsible for an increase in the inspiratory and expiratory pressures generated This feeling of discomfort and the increment of pressures causes shallow and forced breathing and increases the respiratory accessory musculature activation
Person et al observed that the subjects who used a mask felt dyspnea clinically and significantly higher than those who did not use it However to our knowledge no study has analyzed the parameters of physical effort respiratory parameters self-perceived dyspnea and muscle activation using different types of masks in healthy subjects For this reason the present study hypothesis is that there are no changes between wearing and not-wearing a mask surgical or N-95 in the effort and ventilatory parameters even though there may be an increase in the tone of the cervical muscles or the perception of dyspnea using a face mask
This study aims to observe the effect that the surgical mask and the N-95 mask have in the distance walked in the oxygenometry in the heart rate in the sensation of dyspnea and the tone of the inspiratory accessory muscles during the 6 minutes walking test
Procedure After verifying that the subjects meet the inclusion criteria and sign the consent they will be given a registration number An investigator will observe the number in a random list and included the participant in one of the three groups without a mask with a surgical mask and with N95 mask This researcher will make an initial registration of demographic data gender age weight height cardiorespiratory pathology smoker number of cigarettes per day a sport performed hours of daily sport and days of sport per week Before the test all the subjects will have to remain for 30 minutes without a mask breathing normally This phase will be called the resting phase Subsequently the subjects will go to the area where the 6MWT will be carried out Each one of them will be performed the test according to the group to which they will be assigned An investigator blinded to the subsequent assessment will encourage the participants to take the 6MWT according to the recommendations mentioned above After performing the 6MWT all subjects will go to the assessment area All the subjects will wear a surgical mask so that the researcher can not know to which group they have been assigned Besides this researcher will not have access to the registration number or the 6-minute walking test area
At the end of each resting phase SpO2 and baseline HR will be recorded After every 6MWT the HR SpO2 and self-perceived dyspnea will be recorded The muscle tone will also be assessed with the MyotonPRO in middle scalene and SCM
Subjects will have the option of retaking the test going through all the phases mentioned above
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None