Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04805489
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2021-03-12
Brief Title:
Comparison of Hemodynamic and Respiratory Parameters During Physical Activity
Sponsor:
Fondation Hôpital Saint-Joseph
Organization:
Fondation Hôpital Saint-Joseph
Study Overview
Official Title:
Comparison of Hemodynamic and Respiratory Parameters During Physical Activity Without Mask With Surgical Mask and General Public
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
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:
PAM
Brief Summary:
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 Millers study in a church choir with a distance of 075 m between choristers and 14 m between each row after 25 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
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 Millers study in a church choir with a distance of 075 m between choristers and 14 m between each row after 25 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
Detailed Description:
None
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