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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Diagnostic test: CPET with mask; Diagnostic test: CPET without mask

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34093
    • Şensu Dinçer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy athletes
• healthy non-athletes

Exclusion Criteria:

• any musculoskeletal, cardiac or respiratory problem

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: with surgical mask; all participants who were applied CPET with surgical mask	Diagnostic test: CPET with mask; 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.
Active Comparator: without surgical mask; all participants who were applied CPET without surgical mask	Diagnostic test: CPET without mask; Regular cardiopulmonary exercise tests were applied to all participants in phase 1.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Şensu Dinçer

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2021
• Primary Completion (Actual): May 7, 2021
• Study Completion (Actual): May 7, 2021

Study Registration Dates

• First Submitted: February 3, 2022
• First Submitted That Met QC Criteria: March 8, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): March 16, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: exercise; Cardiopulmonary exercise test; surgical mask; COVID-19 (coronovirus-19 disease)
• Other Study ID Numbers: Exercising with a mask

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All individual participant data (IPD)that will underlie results
• IPD Sharing Time Frame: starting 1 year after publication
• IPD Sharing Access Criteria: IPD can be shared by researchers such as exercise physiologists, sports scientist and sport medicine physicians
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No