Cardiorespiratory and Acid-basic Imbalance Caused by Use of Mask

NCT05270538 | Completed

• 1 other identifier: 5.026.897
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Acid-Base Imbalance; Respiration Disorders

Keywords

Masks; Acid-Base Imbalance; physiology

Outcome Measures

Primary Outcomes (8)

• variation of lactate

  arterial puncture for blood gas analysis

  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

  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

  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

  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

  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

  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

  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

  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

Study Arms (1)

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.

Device: Mask Zero Seam Virus Bac-Off Lupo® 98% Polyamide and 2% Elastane

Interventions

Mask Zero Seam Virus Bac-Off Lupo® 98% Polyamide and 2% Elastane DEVICE

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.

comparison of clinical and gasometric parameters between the study group and the control group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy medical students who practice physical activity regularly, at least 3 times a week.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade do Vale do Sapucai: lead

Study Sites (2)

Univas

Pouso Alegre, Minas Gerais, 13140-564, Brazil

Location

Univás

Pouso Alegre, Minas Gerais, 37550000, Brazil

Location

Related Publications (14)

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  PMID: 11116118 BACKGROUND

• Gava 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.

  PMID: 7498982 BACKGROUND

• Negrao 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.

  PMID: 1342828 BACKGROUND

• Medeiros 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.

  PMID: 15558199 BACKGROUND

• Seccareccia 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.

  PMID: 1434592 BACKGROUND

• Forjaz 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.

  PMID: 11153048 BACKGROUND

• Forjaz 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.

  PMID: 15181391 BACKGROUND

• Porcari 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.

  PMID: 27274679 BACKGROUND

• Reis 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.

  PMID: 20861520 BACKGROUND

• Ngomane 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.

  PMID: 30791079 BACKGROUND

• Teodoro 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.

  PMID: 30204655 BACKGROUND

• Kellum JA. Disorders of acid-base balance. Crit Care Med. 2007 Nov;35(11):2630-6. doi: 10.1097/01.CCM.0000286399.21008.64.

  PMID: 17893626 BACKGROUND

• MacIntyre 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.

  PMID: 28039289 BACKGROUND

• Eikenberry 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.

  PMID: 32355904 BACKGROUND

MeSH Terms

Conditions

Acid-Base Imbalance; Respiration Disorders

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Respiratory Tract Diseases

Study Officials

• Antonio Brandão, PhD

  Universidade do Vale do Sapucai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Control group (G1) and study group (G2) were defined from the use of random sampling software that gave numbers to each participant, distributing them between the two groups - participants who removed odd numbers were assigned to G1 while participants who removed even numbers to G2.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd

Model Details: 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

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 8, 2022
• Study Start: November 12, 2020
• Primary Completion: November 12, 2021
• Study Completion: January 12, 2022
• Last Updated: March 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)