HealthyNCT05282472
Exercising With a Surgical Mask in Both Athletic and Non-athletic Individuals
A study testing CPET without mask and CPET with mask in people with Healthy, run by Şensu Dinçer at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to examine the impact of surgical masks on maximal and submaximal exercise in both athlete and non-athlete individuals. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CPET without mask and CPET with mask
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Apr 2021to 7 May 2021
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy athletes
- healthy non-athletes
Who cannot join
- any musculoskeletal, cardiac or respiratory problem
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercising With a Surgical Mask is Safe But Decreases Performance in Both Athletic and Non-athletic Individuals
This study aimed to examine the impact of surgical masks on maximal and submaximal exercise in both athlete and non-athlete individuals.
Read the detailed description
All participants will be informed about the procedure and, will sign an informed consent form. They will undergone a detailed physical examination before enrollment in the study. The study is conducted in 2-phases, in non-randomized, controlled design. Cardiopulmonary exercise tests (CPET) are going to be performed with and without a surgical mask with 48 hours in between.
- Conditions
- Healthy
- Being tested
- CPET without mask, CPET with mask
- Keywords
- surgical mask, Cardiopulmonary exercise test, COVID-19 (coronovirus-19 disease), exercise
- Medical subject headings
- COVID-19, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPET without maskDiagnostic test
Regular cardiopulmonary exercise tests were applied to all participants in phase 1.
CPET with maskDiagnostic test
A 3-layer surgical mask was placed on CPET device's mask and was fixed with a CPET tribune. In phase 2, as using this combined (surgical mask and device's mask) masks, CPETs were performed in all participants again, after 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| with surgical mask | Experimental | all participants who were applied CPET with surgical mask Receives: Diagnostic Test: CPET with mask |
| without surgical mask | Active comparator | all participants who were applied CPET without surgical mask Receives: Diagnostic Test: CPET without mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum oxygen consumption (VO2max) change between CPET with surgical mask and without surgical mask
Cardiopulmonary exercise test (CPET) is a well known, gold standard test to measure VO2 max during exercise. The higher VO2 max value shows better endurance.VO₂ max is the maximum (max) rate (V) of oxygen (O₂) the body is able to use during exercise
Measured: two CPET tests which will be carried out two days within 2 weeks
max minute ventilation (VEmax) change between CPET with surgical mask and without surgical mask
VEmax is the maximum volume of gas inhaled (inhaled minute volume) or exhaled (exhaled minute volume) from a person's lungs per minute.
Measured: two CPET tests which will be carried out two days within 2 weeks
exercise test duration change between CPET with surgical mask and without surgical mask
CPET duration of a participant
Measured: two CPET tests which will be carried out two days within 2 weeks
end-tidal carbon dioxide pressure (pETCO2) change at the maximum and anaerobic levels of CPET
End-tidal carbon dioxide pressure (pETCO2) is the level of carbon dioxide that is released at the end of an exhaled breath.
Measured: two CPET tests which will be carried out two days within 2 weeks
End-tidal partial oxygen pressure (pETO2) change at the maximum and anaerobic levels of CPET
refers to PO2 of exhaled gas. It is measured at the end of exhalation and its units are mm Hg.
Measured: two CPET tests which will be carried out two days within 2 weeks
Tidal volume (TV) change at the maximum and anaerobic levels of CPET
TV that volume of air moved into or out of the lungs during quiet breathing
Measured: two CPET tests which will be carried out two days within 2 weeks
Secondary outcomes (6)
minute ventilation at anerobic level (VEan) results of athlete and non-athlete comparison
The VEan difference in between the changes in CPETs with and without masks of athletes and non-athletes
Measured: 2 weeks
maximum minute ventilation (VEmax) results of athlete and non-athlete comparison
The VEmax difference in between the changes in CPETs with and without masks of athletes and non-athletes
Measured: 2 weeks
VO2max results of athlete and non-athlete comparison
The VO2max difference in between the changes in CPETs with and without masks of athletes and non-athletes
Measured: 2 weeks
VO2an results of athlete and non-athlete comparison
The VO2an difference in between the changes in CPETs with and without masks of athletes and non-athletes
Measured: 2 weeks
PETO2 results of athlete and non-athlete comparison
The PETO2 difference in between the changes in CPETs with and without masks of athletes and non-athletes
Measured: 2 weeks
PETCO2
The PETCO2 difference in between the changes in CPETs with and without masks of athletes and non-athletes
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start16 Apr 2021
- Primary completion7 May 2021
- Study completion7 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- A prospective, crossover designed study was conducted in 2 phases. Cardiopulmonary exercise test was performed with and without surgical mask in all participants in between 48 hours. The participant group was further divided into two groups as athlete and non-athlete. In first step, parameters were compared between the CPET tests performed with and without surgical masks. In second step, athletes' and non-athletes' parameters were compared during CPET tests performed with surgical mask.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Şensu Dinçer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Şensu Dinçer, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282472
- Sponsor's protocol ID
- Exercising with a mask
- Status last verified
- Mar 2022
- First submitted
- 3 Feb 2022
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (IPD)that will underlie results
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercising With a Surgical Mask is Safe But Decreases Performance in Both Athletic and Non-athletic Individuals
- ClinicalTrials.gov ID
- NCT05282472
- Acronym / sponsor ID
- Exercising with a mask
- Conditions
- Healthy
- Keywords
- surgical mask, Cardiopulmonary exercise test, COVID-19 (coronovirus-19 disease), exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Şensu DinçerUniversity, hospital or other
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- 7 May 2021 (actual)
- Study completion
- 7 May 2021 (actual)
- First posted
- 16 Mar 2022 (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.
This study aimed to examine the impact of surgical masks on maximal and submaximal exercise in both athlete and non-athlete individuals.
Detailed description
All participants will be informed about the procedure and, will sign an informed consent form. They will undergone a detailed physical examination before enrollment in the study. The study is conducted in 2-phases, in non-randomized, controlled design. Cardiopulmonary exercise tests (CPET) are going to be performed with and without a surgical mask with 48 hours in between.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, crossover designed study was conducted in 2 phases. Cardiopulmonary exercise test was performed with and without surgical mask in all participants in between 48 hours. The participant group was further divided into two groups as athlete and non-athlete. In first step, parameters were compared between the CPET tests performed with and without surgical masks. In second step, athletes' and non-athletes' parameters were compared during CPET tests performed with surgical mask.
| Arm | Type | Receives |
|---|---|---|
| with surgical mask | Experimental | Diagnostic Test: CPET with maskall participants who were applied CPET with surgical mask |
| without surgical mask | Active comparator | Diagnostic Test: CPET without maskall participants who were applied CPET without surgical mask |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy athletes
- healthy non-athletes
Key exclusion criteria (1 listed)
- any musculoskeletal, cardiac or respiratory problem
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 |
|---|---|---|
| CPET without maskRegular cardiopulmonary exercise tests were applied to all participants in phase 1. | Diagnostic test | without surgical mask |
| CPET with maskA 3-layer surgical mask was placed on CPET device's mask and was fixed with a CPET tribune. In phase 2, as using this combined (surgical mask and device's mask) masks, CPETs were performed in all participants again, after 48 hours. | Diagnostic test | with surgical mask |
Primary outcome
maximum oxygen consumption (VO2max) change between CPET with surgical mask and without surgical mask
Time frame: two CPET tests which will be carried out two days within 2 weeks
Cardiopulmonary exercise test (CPET) is a well known, gold standard test to measure VO2 max during exercise. The higher VO2 max value shows better endurance.VO₂ max is the maximum (max) rate (V) of oxygen (O₂) the body is able to use during exercise
max minute ventilation (VEmax) change between CPET with surgical mask and without surgical mask
Time frame: two CPET tests which will be carried out two days within 2 weeks
VEmax is the maximum volume of gas inhaled (inhaled minute volume) or exhaled (exhaled minute volume) from a person's lungs per minute.
exercise test duration change between CPET with surgical mask and without surgical mask
Time frame: two CPET tests which will be carried out two days within 2 weeks
CPET duration of a participant
end-tidal carbon dioxide pressure (pETCO2) change at the maximum and anaerobic levels of CPET
Time frame: two CPET tests which will be carried out two days within 2 weeks
End-tidal carbon dioxide pressure (pETCO2) is the level of carbon dioxide that is released at the end of an exhaled breath.
End-tidal partial oxygen pressure (pETO2) change at the maximum and anaerobic levels of CPET
Time frame: two CPET tests which will be carried out two days within 2 weeks
refers to PO2 of exhaled gas. It is measured at the end of exhalation and its units are mm Hg.
Tidal volume (TV) change at the maximum and anaerobic levels of CPET
Time frame: two CPET tests which will be carried out two days within 2 weeks
TV that volume of air moved into or out of the lungs during quiet breathing
6 secondary outcomes
minute ventilation at anerobic level (VEan) results of athlete and non-athlete comparison
Time frame: 2 weeks
maximum minute ventilation (VEmax) results of athlete and non-athlete comparison
Time frame: 2 weeks
VO2max results of athlete and non-athlete comparison
Time frame: 2 weeks
VO2an results of athlete and non-athlete comparison
Time frame: 2 weeks
PETO2 results of athlete and non-athlete comparison
Time frame: 2 weeks
PETCO2
Time frame: 2 weeks
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 16 Mar 2022.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD)that will underlie results
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPET without mask and CPET with mask in people with Healthy, run by Şensu Dinçer at 1 site in Turkey (Türkiye).
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 2 inclusion and 1 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 16 Mar 2022. 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 Turkey (Türkiye). 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?
maximum oxygen consumption (VO2max) change between CPET with surgical mask and without surgical mask (time frame: two CPET tests which will be carried out two days within 2 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2022.