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Effects of Using Mask During the 6-minute Walking Test in Times of COVID-19

Primary Purpose

Pulmonary Disease, Covid19, Physical Disability

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
6-min-walk surgical mask
6-min-walk Fpp2
6-min-walk without mask
Sponsored by
Universitat Internacional de Catalunya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pulmonary Disease focused on measuring covid-19, muscle tone, mask

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age> 18 years
  • Being able to perform the 6 min-walk-test-

Exclusion Criteria:

  • Cardiac-respiratory diseases
  • Red flags.

Sites / Locations

  • Universitat Internacional de Catalunya
  • Universitat Internacional de CatalunyaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Without Mask Group

Surgical Mask

Fpp2 Mask

Arm Description

Patients who will perform the 6-min walk test without mask

Patients who will perform the 6-min walk test with surgical mask

Patients who will perform the 6-min walk test with Fpp2 mask

Outcomes

Primary Outcome Measures

6 minutes walk test (minutes)
The volunteers had to walk as fast as possible without running for 6 minutes. Each minute, the subjects will be encouraged to continue at the same pace and not stop

Secondary Outcome Measures

Dyspnea using the visual analogue scale (VAS) (cms)
Dyspnea sensation in the visual analogue scale (0 to 100 cms).
Heart Rate (b/min)
With a pulse oximeter (b/min).
Transcutaneous oxygen saturation (% of saturation)
With a pulse oximeter (SpO2).
Frequency Muscle tone with MyotonePRO device (Hz)
The Myoton PRO device will be used to register the respiratory accessory muscle tone. This handheld device was designed to assess the muscle and its characteristics. A brief mechanical impulse on the skin generates a natural oscillation of the tissues that cushion it.
Dynamic Stiffness Muscle tone with MyotonePRO device (N/m)
The Myoton PRO device will be used to register the respiratory accessory muscle tone. This handheld device was designed to assess the muscle and its characteristics. A brief mechanical impulse on the skin generates a natural oscillation of the tissues that cushion it.
Muscle viscoelasticy with MyotonePRO device (ms)
The Myoton PRO device will be used to register the respiratory accessory muscle tone. This handheld device was designed to assess the muscle and its characteristics. A brief mechanical impulse on the skin generates a natural oscillation of the tissues that cushion it.

Full Information

First Posted
March 4, 2021
Last Updated
May 10, 2021
Sponsor
Universitat Internacional de Catalunya
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1. Study Identification

Unique Protocol Identification Number
NCT04789603
Brief Title
Effects of Using Mask During the 6-minute Walking Test in Times of COVID-19
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 10, 2021 (Anticipated)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat Internacional de Catalunya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Since the beginning of the pandemic caused by SARC-CoV 2, more than 81 million cases have been diagnosed and caused around 1,7 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 virus's 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, and/or 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 1,7 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 virus's 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, and/or 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Covid19, Physical Disability
Keywords
covid-19, muscle tone, mask

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Masking Description
For randomization a computer software (www.random.org) will be used.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Without Mask Group
Arm Type
Active Comparator
Arm Description
Patients who will perform the 6-min walk test without mask
Arm Title
Surgical Mask
Arm Type
Active Comparator
Arm Description
Patients who will perform the 6-min walk test with surgical mask
Arm Title
Fpp2 Mask
Arm Type
Experimental
Arm Description
Patients who will perform the 6-min walk test with Fpp2 mask
Intervention Type
Other
Intervention Name(s)
6-min-walk surgical mask
Intervention Description
To walk as fast as possible without running for 6 minutes with surgical mask
Intervention Type
Other
Intervention Name(s)
6-min-walk Fpp2
Intervention Description
To walk as fast as possible without running for 6 minutes with Fpp2 mask
Intervention Type
Other
Intervention Name(s)
6-min-walk without mask
Intervention Description
To walk as fast as possible without running for 6 minutes without mask
Primary Outcome Measure Information:
Title
6 minutes walk test (minutes)
Description
The volunteers had to walk as fast as possible without running for 6 minutes. Each minute, the subjects will be encouraged to continue at the same pace and not stop
Time Frame
Change between baseline (immediately before intervention) and post intervention (immediately after intervention)
Secondary Outcome Measure Information:
Title
Dyspnea using the visual analogue scale (VAS) (cms)
Description
Dyspnea sensation in the visual analogue scale (0 to 100 cms).
Time Frame
Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Title
Heart Rate (b/min)
Description
With a pulse oximeter (b/min).
Time Frame
Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Title
Transcutaneous oxygen saturation (% of saturation)
Description
With a pulse oximeter (SpO2).
Time Frame
Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Title
Frequency Muscle tone with MyotonePRO device (Hz)
Description
The Myoton PRO device will be used to register the respiratory accessory muscle tone. This handheld device was designed to assess the muscle and its characteristics. A brief mechanical impulse on the skin generates a natural oscillation of the tissues that cushion it.
Time Frame
Change between baseline and post intervention (1 month), after 3 months and after 6 months
Title
Dynamic Stiffness Muscle tone with MyotonePRO device (N/m)
Description
The Myoton PRO device will be used to register the respiratory accessory muscle tone. This handheld device was designed to assess the muscle and its characteristics. A brief mechanical impulse on the skin generates a natural oscillation of the tissues that cushion it.
Time Frame
Change between baseline and post intervention (1 month), after 3 months and after 6 months
Title
Muscle viscoelasticy with MyotonePRO device (ms)
Description
The Myoton PRO device will be used to register the respiratory accessory muscle tone. This handheld device was designed to assess the muscle and its characteristics. A brief mechanical impulse on the skin generates a natural oscillation of the tissues that cushion it.
Time Frame
Change between baseline and post intervention (1 month), after 3 months and after 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age> 18 years Being able to perform the 6 min-walk-test- Exclusion Criteria: Cardiac-respiratory diseases Red flags.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacobo Rodríguez-Sanz, PhD
Phone
+34636136789
Email
jrodriguezs@uic.es
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos López-de-Celis, PhD
Phone
+34606806767
Email
carlesldc@uic.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Pérez-Bellmunt, PhD
Organizational Affiliation
Universitat Internacional de Catalunya
Official's Role
Study Director
Facility Information:
Facility Name
Universitat Internacional de Catalunya
City
Sant Cugat Del Vallès
State/Province
Barcelona
ZIP/Postal Code
08195
Country
Spain
Individual Site Status
Completed
Facility Name
Universitat Internacional de Catalunya
City
Sant Cugat Del Vallès
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Albert Pérez-Bellmunt, Dr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Using Mask During the 6-minute Walking Test in Times of COVID-19

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