Clinical trial NCT05282472: Exercising With a Surgical Mask in Both Athletic and Non-athletic Individuals
Official title: Exercising With a Surgical Mask is Safe But Decreases Performance in Both Athletic and Non-athletic Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: surgical mask
Cardiopulmonary exercise test
COVID-19 (coronovirus-19 disease)
exercise
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: SCREENING

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* healthy athletes
* healthy non-athletes

Exclusion Criteria:

* any musculoskeletal, cardiac or respiratory problem

Primary outcomes:
measure: maximum oxygen consumption (VO2max) change between CPET with surgical mask and without surgical mask
timeFrame: two CPET tests which will be carried out two days within 2 weeks
measure: max minute ventilation (VEmax) change between CPET with surgical mask and without surgical mask
timeFrame: two CPET tests which will be carried out two days within 2 weeks
measure: exercise test duration change between CPET with surgical mask and without surgical mask
timeFrame: two CPET tests which will be carried out two days within 2 weeks
measure: end-tidal carbon dioxide pressure (pETCO2) change at the maximum and anaerobic levels of CPET
timeFrame: two CPET tests which will be carried out two days within 2 weeks
measure: End-tidal partial oxygen pressure (pETO2) change at the maximum and anaerobic levels of CPET
timeFrame: two CPET tests which will be carried out two days within 2 weeks
measure: Tidal volume (TV) change at the maximum and anaerobic levels of CPET
timeFrame: two CPET tests which will be carried out two days within 2 weeks
Secondary outcomes:
measure: minute ventilation at anerobic level (VEan) results of athlete and non-athlete comparison
timeFrame: 2 weeks
measure: maximum minute ventilation (VEmax) results of athlete and non-athlete comparison
timeFrame: 2 weeks
measure: VO2max results of athlete and non-athlete comparison
timeFrame: 2 weeks
measure: VO2an results of athlete and non-athlete comparison
timeFrame: 2 weeks
measure: PETO2 results of athlete and non-athlete comparison
timeFrame: 2 weeks
measure: PETCO2
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Şensu Dinçer
Study officials:
References: