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

NCT05282472 | Completed

• 1 other identifier: Exercising with a mask
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

surgical mask; Cardiopulmonary exercise test; COVID-19 (coronovirus-19 disease); exercise

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• minute ventilation at anerobic level (VEan) results of athlete and non-athlete comparison

  2 weeks

• maximum minute ventilation (VEmax) results of athlete and non-athlete comparison

  2 weeks

• VO2max results of athlete and non-athlete comparison

  2 weeks

• VO2an results of athlete and non-athlete comparison

  2 weeks

• PETO2 results of athlete and non-athlete comparison

  2 weeks

Study Arms (2)

with surgical mask

EXPERIMENTAL

all participants who were applied CPET with surgical mask

Diagnostic Test: CPET with mask

without surgical mask

ACTIVE COMPARATOR

all participants who were applied CPET without surgical mask

Diagnostic Test: CPET without mask

Interventions

CPET without mask DIAGNOSTIC_TEST

Regular cardiopulmonary exercise tests were applied to all participants in phase 1.

without surgical mask

CPET with mask DIAGNOSTIC_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.

with surgical mask

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy athletes
• healthy non-athletes

You may not qualify if:

• any musculoskeletal, cardiac or respiratory problem

Sponsors & Collaborators

• Şensu Dinçer: lead

Study Sites (1)

Şensu Dinçer

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19; Motor Activity

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: medical doctor

Model Details: 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.

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: March 16, 2022
• Study Start: April 16, 2021
• Primary Completion: May 7, 2021
• Study Completion: May 7, 2021
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: starting 1 year after publication
• Access Criteria: IPD can be shared by researchers such as exercise physiologists, sports scientist and sport medicine physicians

Locations

TU (1)