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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05282472
• Other study ID #: Exercising with a mask
• Status: Completed
• Phase: N/A
• Start date: April 16, 2021
• Est. completion date: May 7, 2021

Study information

• Verified date: March 2022
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 7, 2021
• Est. primary completion date: May 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• healthy athletes

• healthy non-athletes

Exclusion Criteria:

• any musculoskeletal, cardiac or respiratory problem

Related Conditions & MeSH terms

• Healthy

Intervention

Diagnostic Test:
• CPET without mask
Regular cardiopulmonary exercise tests were applied to all participants in phase 1.
• 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.

Locations

Country	Name	City	State
Turkey	Sensu Dinçer	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sensu Dinçer

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	PETCO2	The PETCO2 difference in between the changes in CPETs with and without masks of athletes and non-athletes	2 weeks