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Cardiovascular Check-upPAMNCT04805489

Comparison of Hemodynamic and Respiratory Parameters During Physical Activity

A study testing Mask in people with Cardiovascular Check-up, run by Fondation Hôpital Saint-Joseph at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiovascular Check-up
What is being tested?
Mask
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteFrance
Study dates
26 Mar 2021to 30 Apr 2023
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site
  • Groupe Hospitalier Paris Saint-Joseph

    Paris, Groupe Hospitalier Paris Saint-Joseph, 75014

Other trials in France

About this study

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

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.

Read more

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.

Being tested
Mask

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MaskOther

    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.

Study groups in NCT04805489
Study groupRoleWhat they receive
stress test with masksExperimentalWithin 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.
Receives: Other: Mask

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. peak VO2

    The peak VO 2 will be measured during cardiac stress test for each mask at 1 month, to compare the 3 masks.

    Measured: Month 1

Secondary outcomes (3)
  1. 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.

    Measured: Month 1

  2. 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.

    Measured: Month 1

  3. 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

    Measured: Month 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2021
  2. Study start26 Mar 2021
  3. Primary completion18 Oct 2021
  4. Study completion30 Apr 2023

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04805489
Sponsor's protocol ID
PAM
Acronym
PAM
Status last verified
Sep 2023
First submitted
12 Mar 2021
Last updated
13 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Fikenzer S, Uhe T, Lavall D, Rudolph U, Falz R, Busse M, Hepp P, Laufs U. Effects of surgical and FFP2/N95 face masks on cardiopulmonary exercise capacity. Clin Res Cardiol. 2020 Dec;109(12):1522-1530. doi: 10.1007/s00392-020-01704-y. Epub 2020 Jul 6.

    PubMed 32632523
  • Miller SL, Nazaroff WW, Jimenez JL, Boerstra A, Buonanno G, Dancer SJ, Kurnitski J, Marr LC, Morawska L, Noakes C. Transmission of SARS-CoV-2 by inhalation of respiratory aerosol in the Skagit Valley Chorale superspreading event. Indoor Air. 2021 Mar;31(2):314-323. doi: 10.1111/ina.12751. Epub 2020 Oct 13.

    PubMed 32979298
  • Moser MR, Bender TR, Margolis HS, Noble GR, Kendal AP, Ritter DG. An outbreak of influenza aboard a commercial airliner. Am J Epidemiol. 1979 Jul;110(1):1-6. doi: 10.1093/oxfordjournals.aje.a112781.

    PubMed 463858
  • Shen Y, Li C, Dong H, Wang Z, Martinez L, Sun Z, Handel A, Chen Z, Chen E, Ebell MH, Wang F, Yi B, Wang H, Wang X, Wang A, Chen B, Qi Y, Liang L, Li Y, Ling F, Chen J, Xu G. Community Outbreak Investigation of SARS-CoV-2 Transmission Among Bus Riders in Eastern China. JAMA Intern Med. 2020 Dec 1;180(12):1665-1671. doi: 10.1001/jamainternmed.2020.5225.

    PubMed 32870239

Questions about this trial

What is this clinical trial studying?

A study testing Mask in people with Cardiovascular Check-up, run by Fondation Hôpital Saint-Joseph at 1 site in France.

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 7 inclusion and 5 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 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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?

peak VO2 (time frame: Month 1). 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 NCT04805489, which also lists 4 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 13 Sep 2023.

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