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.
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
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.
- Conditions
- Cardiovascular Check-up
- 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 group | Role | What they receive |
|---|---|---|
| stress test with masks | Experimental | 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. Receives: Other: Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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.
- First posted18 Mar 2021
- Study start26 Mar 2021
- Primary completion18 Oct 2021
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Check-upStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Duc, MD, Principal investigator, Fondation Hôpital Saint-Joseph
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 32632523Miller 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 32979298Moser 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 463858Shen 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hemodynamic and Respiratory Parameters During Physical Activity Without Mask, With Surgical Mask and General Public
- ClinicalTrials.gov ID
- NCT04805489
- Acronym / sponsor ID
- PAM / PAM
- Conditions
- Cardiovascular Check-up
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 18 Oct 2021 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stress test with masks | Experimental | Other: MaskWithin 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MaskThe 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. | Other | stress test with masks |
Primary outcome
peak VO2
Time frame: Month 1
The peak VO 2 will be measured during cardiac stress test for each mask at 1 month, to compare the 3 masks.
3 secondary outcomes
Comparaison of Modification of cardiac parameters between 3 masks
Time frame: Month 1
Comparaison of Changes in lung parameters between 3 masks
Time frame: Month 1
Degree of discomfort felt
Time frame: Month 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Results publication: PubMed 32632523Fikenzer 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.
- Results publication: PubMed 32979298Miller 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.
- Results publication: PubMed 463858Moser 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.
- Results publication: PubMed 32870239Shen 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.
Related trials for Cardiovascular Check-up
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
Not yet recruitingObservational study
Cardiovascular Pre-participation Screening in Children and Adolescents
Sudden Cardiac Death, Cardiac Arrhythmias
RecruitingObservational study
Hyperpolarized 13C Pyruvate-MRI and FDG-PET in a Single Exam for the Prognosis of Ischemic Cardiomyopathy
Coronary Artery Disease, Coronary Artery Bypass Graft (CABG)
Active, not recruiting
Impact of Neurochecks on Sleep in Critically Ill Adults
Cerebral Aneurysm
RecruitingObservational study
Examining Relationships Between Musculoskeletal Function Measurements of Movement Efficiency and Nervous System Function After Chronic Stroke
Stroke, Osteopathic Medicine
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Duc, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
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.