Comparison of Hemodynamic and Respiratory Parameters During Physical Activity

Study Overview
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Brief Summary
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The COVID-19 pandemic has completely changed societal activity, including physical activity. Recommendations for wearing masks vary from country to country, region to region, and may be mandatory or optional in indoor or outdoor environments. During physical activities, the latest ministerial recommendations are that wearing a mask is not mandatory even in case of close distance of less than one meter and in case of physical contact (ministerial recommendations of September 19, 2020), even in regions where wearing a mask is mandatory outdoors. This is based on elements not explained by the Ministry of Sports and partly on elements showing a limitation of respiratory capacities during exercise tests with gas exchange measurements. Indeed, subjects with FFP2 masks have their maximal capacity to effort and VO2max decreased as well as the respiratory capacities whether at rest or during effort in comparison with subjects without mask and to a lesser degree with surgical masks. However, the FFP2 mask is not recommended by the medical or sports authorities, and surgical or general public masks are recommended. Moreover, during leisure time physical activities, it is not frequent that the subjects need to be at their maximum physical capacity. This moderate loss of physical capacity at the peak of the effort is for most amateur athletes not relevant in their practice. In addition, airborne transmission of COVID-19 has been shown in several studies: in a choir, on a commercial airplane, on a bus, and close contact is a secondary source of contamination. There is concern that physical activity in non-open environments is becoming a source of COVID-19 contamination. In studies in non-open environments (bus, church, airplane), the degree of contamination in a so-called confined atmosphere varies between 35 and 85%. In Miller's study, in a church choir with a distance of 0.75 m between choristers and 1.4 m between each row, after 2.5 hours of rehearsal including breaks and buffet, without wearing a mask and with social distancing, hand washing with a hydro-alcoholic solution and reduction of contacts, the contamination with a single patient was 85% on a total of 61 choristers. One can imagine what the degree of contamination would be during a physical activity in a gymnasium without wearing a mask, even with hand and foot washing and floor decontamination. Currently, all sports activities are stopped but they will start again sooner or later. Before the recontainment, according to the directives of the Ministry of Sports, the wearing of masks was not compulsory and it was not recommended in outdoor activities (golf...) and in gymnasiums including activities with contact (judo, dance...). Many people are reluctant to wear a mask during sports activities: discomfort, fear of loss of performance, hypoxia... However, it seems essential to us to determine, during a physical activity, what are the cardiac and respiratory consequences of wearing a surgical or general public mask, before resuming sports activities in a few weeks or months. It seems important to us to determine the degree of deterioration of the cardiac and pulmonary physical capacities during physical leisure activities which concern more than 99% of the leisure activities as opposed to the sports activities practised by professionals, this to enlighten the practitioners and the ministerial authorities on the possible non-deterioration of the physical capacities with the effort and the absence of deleterious effect of the wearing of a mask.

Official Title
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Comparison of Hemodynamic and Respiratory Parameters During Physical Activity Without Mask, With Surgical Mask and General Public

Conditions
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Cardiovascular Check-up

Intervention / Treatment
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* Other: Mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Athletic person coming to the GHPSJ for a cardiovascular check-up Person whose age is ≥ 18 years old Person practicing a sport for more than 1 year Regularly practicing sports (> 2 hours weekly) Person affiliated with a health insurance plan French-speaking person Person who has given free, informed and written consent Exclusion Criteria: Pregnant or breastfeeding women Persons under guardianship or trusteeship Person deprived of liberty Person symptomatic of a disease Person with a history of heart or lung disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stress test with masks<br>Within the framework of this research, an additional stress test is performed. This stress test, consisting of 3 periods, will follow a cardiovascular assessment requested as part of a health check-up, a license application, for risk factor assessment. | Other: Mask<br>* The sequence of mask wearing will be done by drawing lots, in double blind. Only the nurse will be informed of the mask sequence. The doctor will take measurements without seeing the type of mask placed between the athlete's face and the VO2 mask. The patient will not know which mask will be applied. He will have been informed that he will test three masks (a so-called high-tech mask which will in fact be without a mask, a surgical mask and a general public mask). When the mask is put on, the athlete's eyes will be closed, the sequence without a mask, presented to the subject as a high-tech mask, will be done with a mask that will be put on like a surgical mask or a mask for the general public, except that it will be hollowed out in its center. The effort tests will be done on a carpet with a filter called COVID on the VO2 masks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peak VO2 | The peak VO 2 will be measured during cardiac stress test for each mask at 1 month, to compare the 3 masks. | Month 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparaison of Modification of cardiac parameters between 3 masks | This outome corresponds to the evaluation of modification of cardiac parameters: heart rate, blood pressure between the 3 masks. | Month 1 | 
| Comparaison of Changes in lung parameters between 3 masks | This ouctome corresponds to the evaluation of modification of lung parameters: respiratory rate, exhaled volumes, power reached at maximum effort between the 3 masks. | Month 1 | 
| Degree of discomfort felt | This ouctome correspond to lickert's scale. Questionnaire: Are you satisfied with the mask you have just worn? Responses: Totally agree/Agree/Somewhat agree/Somewhat disagree/Disagree | Month 1 |