Comparison of Hemodynamic and Respiratory Parameters During Physical Activity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-26

Study Completion Date

2023-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Facemask on Cardiorespiratory Performance

NCT04963049

Facemask Impact on Cardiorespiratory Performance

COMPLETED NA

Effects of a Face Mask on Oxygenation During Exercise

NCT04557605

Hypoxemia

COMPLETED NA

Physical Activity and the Risk of COVID-19 Infection and Mortality

NCT04631861

Covid19

COMPLETED

Effect of Physical Activity Pattern on Cardiometabolic Health

NCT05838508

Life Style

RECRUITING NA

Feasibility and Safety of High-intensity Exercise Training in Patients Surviving COVID-19

NCT04549337

COVID-19

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Check-up

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

stress test with masks

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.

Group Type EXPERIMENTAL

Mask

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mask

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No