Acid-Base ImbalanceNCT05270538
Cardiorespiratory and Acid-basic Imbalance Caused by Use of Mask
A study testing Mask Zero Seam Virus Bac-Off Lupo® 98% Polyamide and 2% Elastane in people with Acid-Base Imbalance and Respiration Disorders, run by Universidade do Vale do Sapucai at 2 sites in Brazil.
Trial summary
The study aims to evaluate whether the use of polypropylene and elastane Lupo ® masks can be considered as a significant causal agent in cases of respiratory and acid-base imbalances. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Acid-Base Imbalance, Respiration Disorders
- What is being tested?
- Mask Zero Seam Virus Bac-Off Lupo® 98% Polyamide and 2% Elastane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 2 sitesBrazil
- Study dates
- 12 Nov 2020to 12 Jan 2022
- Phase
- Interventional
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy medical students who practice physical activity regularly, at least 3 times a week.
Who cannot join
- people who do not accept to participate in the study, refusing to sign the free and informed consent form.
- Sedentary people
- people with major cardiorespiratory diseases or comorbidity
- people tested positive for Covid-19 or other respiratory-infectious diseases in less that 15 days
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Univas
Pouso Alegre, Minas Gerais, 13140-564
Univás
Pouso Alegre, Minas Gerais, 37550000
About this study
Official title: Cardiorespiratory and Acid-basic Imbalance Caused by Use of Face Mask, During Physical Exercices
The study aims to evaluate whether the use of polypropylene and elastane Lupo ® masks can be considered as a significant causal agent in cases of respiratory and acid-base imbalances. For this, gas parameters such as lactate, bicarbonate, Sat02, pH, Sat02, P02 and PC02 of people before and after the practice of aerobic physical exercises will be measured. The control group will perform the exercise without wearing a mask and the study group will perform the exercise using a mask.
Read the detailed description
The experimental phase was carried out at the Armação Atlética academy accredited by the Medical School of Pouso Alegre, following all sanitary recommendations in relation to covid-19.
The aerobic exercise performed by the participants consisted of 15 minutes of running on the treadmill without inclination, interspersing the speeds 10 km/h and 12km/h.
The evaluated clinical parameters of blood pressure, heart rate, pulse , O2 saturation and biochemical analyses of lactate, (partial oxygen pressure) PO2, (partial pressure of CO2 (carbon dioxide) PC02,(hydrogenic potential) pH ,- were collected just before exercise and shortly after that - with maximum interval between measurements of 2 minutes- through physical examination of the cardiovascular apparatus using littmann classic stetoscope iii®,Multilaser® sphygmomanometer and digital oximeter; and arterial blood collection for blood gas analysis.
The blood gas parameters were obtained before and after exercise from blood sample collection by arterial puncture of the Radial Artery performed by the nurses responsible for the blood gas service of the Samuel Libânio Clinic hospital in order to avoid errors regarding the technique. After collection, the samples were kept in a heparinized container and under cooling in an appropriate thermal box and were sent within 20 minutes to the laboratory to be analyzed by blood gas analysis.Such measures avoided the formation of microclots in the samples and the dissipation of blood gases to be analyzed as Co2 and O2 thus bypassing such possible random bias. The blood gas samples obtained were sent to the Hcsl Clinical Analysis laboratory where they underwent gas run in werfen's GEM Premier 3500® apparatus.
To perform the study, we defined a control group and study group based on the use of random sampling software that gave numbers to each participant, distributing them between the two groups. The control group will perform the exercise, without using a mask, while the study group will perform the exercise using Masks Zero Mask Sewing Virus Bac-Off Lupo® for the duration of the exercise.The specific use of this trademark mask made of 98% Polyamide and 2% Elastane ensures that there will be no variations within the study group regarding the composition of the mask, which could result in variable degrees of seals and, therefore, confounding bias to the study.
As an additional safety measure, especially for participants who have to perform the exercise without mask, since they can reinfect themselves, mobile transparent polymer plates for both groups will be temporarily installed around the treadmill. The appliance will be sanitized after each participant used it, with alcohol 70.
After performing the exercise, participants must complete the socio-demographic form sent via Forms in order to characterize such group regarding gender, weight age of participants.
The data acquired through the experiment received static treatments such as a. Classificationtest Signed by Wilcoxon by the statistician of the University of Vale do Sapucaí- Univás).
- Conditions
- Acid-Base Imbalance, Respiration Disorders
- Being tested
- Mask Zero Seam Virus Bac-Off Lupo® 98% Polyamide and 2% Elastane
- Keywords
- Masks, Acid-Base Imbalance, physiology
- Medical subject headings
- Acid-Base Imbalance, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mask Zero Seam Virus Bac-Off Lupo® 98% Polyamide and 2% ElastaneDevice
The 26 participants allocated as G2 had to perform the physical exercise using the Zero Sewing Virus Bac-Off Virus® 98% Polyamide and 2% Elastane, in order to totally seal the nose and mouth.
| Study group | Role | What they receive |
|---|---|---|
| comparison of clinical and gasometric parameters between the study group and the control group | Active comparator | To carry out the study, we defined a control group and a study group distributing them between the two groups. The control group will perform the exercise, without using a mask, while the study group will perform the exercise using Masks Zero Mask Sewing Virus Bac-Off Lupo® for the duration of the exercise.
The exercise consisted of 15 minutes of treadmill without inclination interspersing every 2 minutes at speeds 10 Km/h and 12 Km/h, being by definition of a dynamic aerobic exercise of intensity 4 of 5 in the Borg scale- classification of the intensity of physical exercise. Physical activity was performed in water deprivation and fasting at least 30 minutes before the start of activated. Receives: Device: Mask Zero Seam Virus Bac-Off Lupo® 98% Polyamide and 2% Elastane |
What is being measured
The primary outcome is the main question the study is designed to answer.
variation of lactate
arterial puncture for blood gas analysis
Measured: This variation of blood parameter was obtained through the blood gas analysis to which the participants were submitted just before the beginning of the physical exercise - with a maximum time interval of 2 minutes- and later comparing these
variation of pH
arterial puncture for blood gas analysis
Measured: This variation of blood parameter was obtained through the blood gas analysis to which the participants were submitted just before the beginning of the physical exercise - with a maximum time interval of 2 minutes- and later comparing these
variation of P02
arterial puncture for blood gas analysis
Measured: This variation of blood parameter was obtained through the blood gas analysis to which the participants were submitted just before the beginning of the physical exercise - with a maximum time interval of 2 minutes- and later comparing these
variation of PC02
arterial puncture for blood gas analysis
Measured: This variation of blood parameter was obtained through the blood gas analysis to which the participants were submitted just before the beginning of the physical exercise - with a maximum time interval of 2 minutes- and later comparing these
variation of Sat02
arterial puncture for blood gas analysis
Measured: This variation of blood parameter was obtained through the blood gas analysis to which the participants were submitted just before the beginning of the physical exercise - with a maximum time interval of 2 minutes- and later comparing these
variation of bicarbonate
arterial puncture for blood gas analysis
Measured: This variation of blood parameter was obtained through the blood gas analysis to which the participants were submitted just before the beginning of the physical exercise - with a maximum time interval of 2 minutes- and later comparing these
heart rate (bpm)
physical examination of the cardiovascular system
Measured: This variation of blood parameter was obtained through the blood gas analysis to which the participants were submitted just before the beginning of the physical exercise - with a maximum time interval of 2 minutes- and later comparing these
blood pressure
physical examination of the cardiovascular system
Measured: This variation of blood parameter was obtained through the blood gas analysis to which the participants were submitted just before the beginning of the physical exercise - with a maximum time interval of 2 minutes- and later comparing these
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start12 Nov 2020
- Primary completion12 Nov 2021
- Study completion12 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Acid-Base ImbalanceStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Of the 57 participants, 26 are allocated as G1 (46.5%) and 31 as G2 (53.5%) After the collection of blood gases and cardiovascular parameters- Systolic Blood Pressure, Diastolic Blood Pressure, Heart Rate and O2 Saturation - before and after physical exercise, all participants answered a socio-demographic questionnaire informing their weight, height and gender, in addition to completing the Informed Consent Form on the experiment
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Vale do Sapucai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Dias da Silva Neto, Universidade do Vale do Sapucai
- Investigators
- Antonio Brandão, PhD, Principal investigator, Universidade do Vale do Sapucai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270538
- Sponsor's protocol ID
- 5.026.897
- Status last verified
- Feb 2022
- First submitted
- 15 Feb 2022
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brum PC, Da Silva GJ, Moreira ED, Ida F, Negrao CE, Krieger EM. Exercise training increases baroreceptor gain sensitivity in normal and hypertensive rats. Hypertension. 2000 Dec;36(6):1018-22. doi: 10.1161/01.hyp.36.6.1018.
PubMed 11116118Gava NS, Veras-Silva AS, Negrao CE, Krieger EM. Low-intensity exercise training attenuates cardiac beta-adrenergic tone during exercise in spontaneously hypertensive rats. Hypertension. 1995 Dec;26(6 Pt 2):1129-33. doi: 10.1161/01.hyp.26.6.1129.
PubMed 7498982Negrao CE, Moreira ED, Brum PC, Denadai ML, Krieger EM. Vagal and sympathetic control of heart rate during exercise by sedentary and exercise-trained rats. Braz J Med Biol Res. 1992;25(10):1045-52.
PubMed 1342828Medeiros A, Oliveira EM, Gianolla R, Casarini DE, Negrao CE, Brum PC. Swimming training increases cardiac vagal activity and induces cardiac hypertrophy in rats. Braz J Med Biol Res. 2004 Dec;37(12):1909-17. doi: 10.1590/s0100-879x2004001200018. Epub 2004 Nov 17.
PubMed 15558199Seccareccia F, Menotti A. Physical activity, physical fitness and mortality in a sample of middle aged men followed-up 25 years. J Sports Med Phys Fitness. 1992 Jun;32(2):206-13.
PubMed 1434592Forjaz CL, Tinucci T, Ortega KC, Santaella DF, Mion D Jr, Negrao CE. Factors affecting post-exercise hypotension in normotensive and hypertensive humans. Blood Press Monit. 2000 Oct-Dec;5(5-6):255-62. doi: 10.1097/00126097-200010000-00002.
PubMed 11153048Forjaz CL, Cardoso CG Jr, Rezk CC, Santaella DF, Tinucci T. Postexercise hypotension and hemodynamics: the role of exercise intensity. J Sports Med Phys Fitness. 2004 Mar;44(1):54-62.
PubMed 15181391Porcari JP, Probst L, Forrester K, Doberstein S, Foster C, Cress ML, Schmidt K. Effect of Wearing the Elevation Training Mask on Aerobic Capacity, Lung Function, and Hematological Variables. J Sports Sci Med. 2016 May 23;15(2):379-86. eCollection 2016 Jun.
PubMed 27274679Reis JF, Millet GP, Malatesta D, Roels B, Borrani F, Vleck VE, Alves FB. Are oxygen uptake kinetics modified when using a respiratory snorkel? Int J Sports Physiol Perform. 2010 Sep;5(3):292-300. doi: 10.1123/ijspp.5.3.292.
PubMed 20861520Ngomane AY, Fernandes B, Guimaraes GV, Ciolac EG. Hypotensive Effect of Heated Water-based Exercise in Older Individuals with Hypertension. Int J Sports Med. 2019 Apr;40(4):283-291. doi: 10.1055/a-0828-8017. Epub 2019 Feb 21.
PubMed 30791079Teodoro CL, Gaspari AF, Berton R, Barbieri JF, Silva M, A A Castano L, Guimaraes P, Moraes AC. Familiarization With Airflow-Restriction Mask During Resistance Exercise: Effect on Tolerance and Total Volume. J Strength Cond Res. 2019 Jul;33(7):1762-1765. doi: 10.1519/JSC.0000000000002828.
PubMed 30204655Kellum JA. Disorders of acid-base balance. Crit Care Med. 2007 Nov;35(11):2630-6. doi: 10.1097/01.CCM.0000286399.21008.64.
PubMed 17893626MacIntyre CR, Zhang Y, Chughtai AA, Seale H, Zhang D, Chu Y, Zhang H, Rahman B, Wang Q. Cluster randomised controlled trial to examine medical mask use as source control for people with respiratory illness. BMJ Open. 2016 Dec 30;6(12):e012330. doi: 10.1136/bmjopen-2016-012330.
PubMed 28039289Eikenberry SE, Mancuso M, Iboi E, Phan T, Eikenberry K, Kuang Y, Kostelich E, Gumel AB. To mask or not to mask: Modeling the potential for face mask use by the general public to curtail the COVID-19 pandemic. Infect Dis Model. 2020 Apr 21;5:293-308. doi: 10.1016/j.idm.2020.04.001. eCollection 2020.
PubMed 32355904
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiorespiratory and Acid-basic Imbalance Caused by Use of Face Mask, During Physical Exercices
- ClinicalTrials.gov ID
- NCT05270538
- Acronym / sponsor ID
- 5.026.897
- Conditions
- Acid-Base Imbalance, Respiration Disorders
- Keywords
- Masks, Acid-Base Imbalance, physiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Universidade do Vale do SapucaiUniversity, hospital or other
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- 12 Nov 2021 (actual)
- Study completion
- 12 Jan 2022 (actual)
- First posted
- 8 Mar 2022 (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 study aims to evaluate whether the use of polypropylene and elastane Lupo ® masks can be considered as a significant causal agent in cases of respiratory and acid-base imbalances. For this, gas parameters such as lactate, bicarbonate, Sat02, pH, Sat02, P02 and PC02 of people before and after the practice of aerobic physical exercises will be measured. The control group will perform the exercise without wearing a mask and the study group will perform the exercise using a mask.
Detailed description
The experimental phase was carried out at the Armação Atlética academy accredited by the Medical School of Pouso Alegre, following all sanitary recommendations in relation to covid-19.
The aerobic exercise performed by the participants consisted of 15 minutes of running on the treadmill without inclination, interspersing the speeds 10 km/h and 12km/h.
The evaluated clinical parameters of blood pressure, heart rate, pulse , O2 saturation and biochemical analyses of lactate, (partial oxygen pressure) PO2, (partial pressure of CO2 (carbon dioxide) PC02,(hydrogenic potential) pH ,- were collected just before exercise and shortly after that - with maximum interval between measurements of 2 minutes- through physical examination of the cardiovascular apparatus using littmann classic stetoscope iii®,Multilaser® sphygmomanometer and digital oximeter; and arterial blood collection for blood gas analysis.
The blood gas parameters were obtained before and after exercise from blood sample collection by arterial puncture of the Radial Artery performed by the nurses responsible for the blood gas service of the Samuel Libânio Clinic hospital in order to avoid errors regarding the technique. After collection, the samples were kept in a heparinized container and under cooling in an appropriate thermal box and were sent within 20 minutes to the laboratory to be analyzed by blood gas analysis.Such measures avoided the formation of microclots in the samples and the dissipation of blood gases to be analyzed as Co2 and O2 thus bypassing such possible random bias. The blood gas samples obtained were sent to the Hcsl Clinical Analysis laboratory where they underwent gas run in werfen's GEM Premier 3500® apparatus.
To perform the study, we defined a control group and study group based on the use of random sampling software that gave numbers to each participant, distributing them between the two groups. The control group will perform the exercise, without using a mask, while the study group will perform the exercise using Masks Zero Mask Sewing Virus Bac-Off Lupo® for the duration of the exercise.The specific use of this trademark mask made of 98% Polyamide and 2% Elastane ensures that there will be no variations within the study group regarding the composition of the mask, which could result in variable degrees of seals and, therefore, confounding bias to the study.
As an additional safety measure, especially for participants who have to perform the exercise without mask, since they can reinfect themselves, mobile transparent polymer plates for both groups will be temporarily installed around the treadmill. The appliance will be sanitized after each participant used it, with alcohol 70.
After performing the exercise, participants must complete the socio-demographic form sent via Forms in order to characterize such group regarding gender, weight age of participants.
The data acquired through the experiment received static treatments such as a. Classificationtest Signed by Wilcoxon by the statistician of the University of Vale do Sapucaí- Univás).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Of the 57 participants, 26 are allocated as G1 (46.5%) and 31 as G2 (53.5%) After the collection of blood gases and cardiovascular parameters- Systolic Blood Pressure, Diastolic Blood Pressure, Heart Rate and O2 Saturation - before and after physical exercise, all participants answered a socio-demographic questionnaire informing their weight, height and gender, in addition to completing the Informed Consent Form on the experiment
| Arm | Type | Receives |
|---|---|---|
| comparison of clinical and gasometric parameters between the study group and the control group | Active comparator | Device: Mask Zero Seam Virus Bac-Off Lupo® 98% Polyamide and 2% ElastaneTo carry out the study, we defined a control group and a study group distributing them between the two groups. The control group will perform the exercise, without using a mask, while the study group will perform the exercise using Masks Zero Mask Sewing Virus Bac-Off Lupo® for the duration of the exercise. The exercise consisted of 15 minutes of treadmill without inclination interspersing every 2 minutes at speeds 10 Km/h and 12 Km/h, being by definition of a dynamic aerobic exercise of intensity 4 of 5 in the Borg scale- classification of the intensity of physical exercise. Physical activity was performed in water deprivation and fasting at least 30 minutes before the start of activated. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy medical students who practice physical activity regularly, at least 3 times a week.
Key exclusion criteria (4 listed)
- people who do not accept to participate in the study, refusing to sign the free and informed consent form.
- Sedentary people
- people with major cardiorespiratory diseases or comorbidity
- people tested positive for Covid-19 or other respiratory-infectious diseases in less that 15 days
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 |
|---|---|---|
| Mask Zero Seam Virus Bac-Off Lupo® 98% Polyamide and 2% ElastaneThe 26 participants allocated as G2 had to perform the physical exercise using the Zero Sewing Virus Bac-Off Virus® 98% Polyamide and 2% Elastane, in order to totally seal the nose and mouth. | Device | comparison of clinical and gasometric parameters between the study group and the control group |
Primary outcome
variation of lactate
Time frame: This variation of blood parameter was obtained through the blood gas analysis to which the participants were submitted just before the beginning of the physical exercise - with a maximum time interval of 2 minutes- and later comparing these
arterial puncture for blood gas analysis
variation of pH
Time frame: This variation of blood parameter was obtained through the blood gas analysis to which the participants were submitted just before the beginning of the physical exercise - with a maximum time interval of 2 minutes- and later comparing these
arterial puncture for blood gas analysis
variation of P02
Time frame: This variation of blood parameter was obtained through the blood gas analysis to which the participants were submitted just before the beginning of the physical exercise - with a maximum time interval of 2 minutes- and later comparing these
arterial puncture for blood gas analysis
variation of PC02
Time frame: This variation of blood parameter was obtained through the blood gas analysis to which the participants were submitted just before the beginning of the physical exercise - with a maximum time interval of 2 minutes- and later comparing these
arterial puncture for blood gas analysis
variation of Sat02
Time frame: This variation of blood parameter was obtained through the blood gas analysis to which the participants were submitted just before the beginning of the physical exercise - with a maximum time interval of 2 minutes- and later comparing these
arterial puncture for blood gas analysis
variation of bicarbonate
Time frame: This variation of blood parameter was obtained through the blood gas analysis to which the participants were submitted just before the beginning of the physical exercise - with a maximum time interval of 2 minutes- and later comparing these
arterial puncture for blood gas analysis
heart rate (bpm)
Time frame: This variation of blood parameter was obtained through the blood gas analysis to which the participants were submitted just before the beginning of the physical exercise - with a maximum time interval of 2 minutes- and later comparing these
physical examination of the cardiovascular system
blood pressure
Time frame: This variation of blood parameter was obtained through the blood gas analysis to which the participants were submitted just before the beginning of the physical exercise - with a maximum time interval of 2 minutes- and later comparing these
physical examination of the cardiovascular system
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Background: PubMed 11116118Brum PC, Da Silva GJ, Moreira ED, Ida F, Negrao CE, Krieger EM. Exercise training increases baroreceptor gain sensitivity in normal and hypertensive rats. Hypertension. 2000 Dec;36(6):1018-22. doi: 10.1161/01.hyp.36.6.1018.
- Background: PubMed 7498982Gava NS, Veras-Silva AS, Negrao CE, Krieger EM. Low-intensity exercise training attenuates cardiac beta-adrenergic tone during exercise in spontaneously hypertensive rats. Hypertension. 1995 Dec;26(6 Pt 2):1129-33. doi: 10.1161/01.hyp.26.6.1129.
- Background: PubMed 1342828Negrao CE, Moreira ED, Brum PC, Denadai ML, Krieger EM. Vagal and sympathetic control of heart rate during exercise by sedentary and exercise-trained rats. Braz J Med Biol Res. 1992;25(10):1045-52.
- Background: PubMed 15558199Medeiros A, Oliveira EM, Gianolla R, Casarini DE, Negrao CE, Brum PC. Swimming training increases cardiac vagal activity and induces cardiac hypertrophy in rats. Braz J Med Biol Res. 2004 Dec;37(12):1909-17. doi: 10.1590/s0100-879x2004001200018. Epub 2004 Nov 17.
- Background: PubMed 1434592Seccareccia F, Menotti A. Physical activity, physical fitness and mortality in a sample of middle aged men followed-up 25 years. J Sports Med Phys Fitness. 1992 Jun;32(2):206-13.
- Background: PubMed 11153048Forjaz CL, Tinucci T, Ortega KC, Santaella DF, Mion D Jr, Negrao CE. Factors affecting post-exercise hypotension in normotensive and hypertensive humans. Blood Press Monit. 2000 Oct-Dec;5(5-6):255-62. doi: 10.1097/00126097-200010000-00002.
- Background: PubMed 15181391Forjaz CL, Cardoso CG Jr, Rezk CC, Santaella DF, Tinucci T. Postexercise hypotension and hemodynamics: the role of exercise intensity. J Sports Med Phys Fitness. 2004 Mar;44(1):54-62.
- Background: PubMed 27274679Porcari JP, Probst L, Forrester K, Doberstein S, Foster C, Cress ML, Schmidt K. Effect of Wearing the Elevation Training Mask on Aerobic Capacity, Lung Function, and Hematological Variables. J Sports Sci Med. 2016 May 23;15(2):379-86. eCollection 2016 Jun.
- Background: PubMed 20861520Reis JF, Millet GP, Malatesta D, Roels B, Borrani F, Vleck VE, Alves FB. Are oxygen uptake kinetics modified when using a respiratory snorkel? Int J Sports Physiol Perform. 2010 Sep;5(3):292-300. doi: 10.1123/ijspp.5.3.292.
- Background: PubMed 30791079Ngomane AY, Fernandes B, Guimaraes GV, Ciolac EG. Hypotensive Effect of Heated Water-based Exercise in Older Individuals with Hypertension. Int J Sports Med. 2019 Apr;40(4):283-291. doi: 10.1055/a-0828-8017. Epub 2019 Feb 21.
- Background: PubMed 30204655Teodoro CL, Gaspari AF, Berton R, Barbieri JF, Silva M, A A Castano L, Guimaraes P, Moraes AC. Familiarization With Airflow-Restriction Mask During Resistance Exercise: Effect on Tolerance and Total Volume. J Strength Cond Res. 2019 Jul;33(7):1762-1765. doi: 10.1519/JSC.0000000000002828.
- Background: PubMed 17893626Kellum JA. Disorders of acid-base balance. Crit Care Med. 2007 Nov;35(11):2630-6. doi: 10.1097/01.CCM.0000286399.21008.64.
- Individual participant dataSharing planned: No
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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.
Antonio Brandão, PhD principal investigator
Universidade do Vale do Sapucai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mask Zero Seam Virus Bac-Off Lupo® 98% Polyamide and 2% Elastane in people with Acid-Base Imbalance and Respiration Disorders, run by Universidade do Vale do Sapucai at 2 sites in Brazil.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
variation of lactate (time frame: This variation of blood parameter was obtained through the blood gas analysis to which the participants were submitted just before the beginning of the physical exercise - with a maximum time interval of 2 minutes- and later comparing these). The study lists 8 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 NCT05270538, which also lists 14 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 8 Mar 2022.