Exercising With a Surgical Mask in Both Athletic and Non-athletic Individuals

Study Overview
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Brief Summary
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This study aimed to examine the impact of surgical masks on maximal and submaximal exercise in both athlete and non-athlete individuals.

Detailed Description
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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.

Official Title
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Exercising With a Surgical Mask is Safe But Decreases Performance in Both Athletic and Non-athletic Individuals

Conditions
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Healthy

Intervention / Treatment
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* Diagnostic Test: CPET without mask
* Diagnostic Test: CPET with mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy athletes healthy non-athletes Exclusion Criteria: any musculoskeletal, cardiac or respiratory problem

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: with surgical mask<br>all participants who were applied CPET with surgical mask | Diagnostic Test: CPET with mask<br>* 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.<br>|
| Active Comparator: without surgical mask<br>all participants who were applied CPET without surgical mask | Diagnostic Test: CPET without mask<br>* Regular cardiopulmonary exercise tests were applied to all participants in phase 1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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 | 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. | 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. | 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 | two CPET tests which will be carried out two days within 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 2 weeks | 
| PETCO2 | The PETCO2 difference in between the changes in CPETs with and without masks of athletes and non-athletes | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgical mask, Cardiopulmonary exercise test, COVID-19 (coronovirus-19 disease), exercise