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Completed

NCT Number: NCT05282472

Exercising With a Surgical Mask 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.

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Key information

Conditions

Healthy Behavior COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Motor Activity Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Şensu Dinçer

Istanbul, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy athletes
  • healthy non-athletes

Exclusion criteria

  • any musculoskeletal, cardiac or respiratory problem

Treatment and study plan

CPET without mask

Diagnostic Test

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

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.

Primary outcomes

  1. maximum oxygen consumption (VO2max) change between CPET with surgical mask and without surgical mask

    Time frame: two CPET tests which will be carried out two days within 2 weeks

    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

  2. max minute ventilation (VEmax) change between CPET with surgical mask and without surgical mask

    Time frame: two CPET tests which will be carried out two days within 2 weeks

    VEmax is the maximum volume of gas inhaled (inhaled minute volume) or exhaled (exhaled minute volume) from a person's lungs per minute.

  3. exercise test duration change between CPET with surgical mask and without surgical mask

    Time frame: two CPET tests which will be carried out two days within 2 weeks

    CPET duration of a participant

  4. end-tidal carbon dioxide pressure (pETCO2) change at the maximum and anaerobic levels of CPET

    Time frame: two CPET tests which will be carried out two days within 2 weeks

    End-tidal carbon dioxide pressure (pETCO2) is the level of carbon dioxide that is released at the end of an exhaled breath.

  5. End-tidal partial oxygen pressure (pETO2) change at the maximum and anaerobic levels of CPET

    Time frame: two CPET tests which will be carried out two days within 2 weeks

    refers to PO2 of exhaled gas. It is measured at the end of exhalation and its units are mm Hg.

  6. Tidal volume (TV) change at the maximum and anaerobic levels of CPET

    Time frame: two CPET tests which will be carried out two days within 2 weeks

    TV that volume of air moved into or out of the lungs during quiet breathing

Secondary outcomes

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

    Time frame: 2 weeks

    The VEan difference in between the changes in CPETs with and without masks of athletes and non-athletes

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

    Time frame: 2 weeks

    The VEmax difference in between the changes in CPETs with and without masks of athletes and non-athletes

  3. VO2max results of athlete and non-athlete comparison

    Time frame: 2 weeks

    The VO2max difference in between the changes in CPETs with and without masks of athletes and non-athletes

  4. VO2an results of athlete and non-athlete comparison

    Time frame: 2 weeks

    The VO2an difference in between the changes in CPETs with and without masks of athletes and non-athletes

  5. PETO2 results of athlete and non-athlete comparison

    Time frame: 2 weeks

    The PETO2 difference in between the changes in CPETs with and without masks of athletes and non-athletes

  6. PETCO2

    Time frame: 2 weeks

    The PETCO2 difference in between the changes in CPETs with and without masks of athletes and non-athletes

Sponsors and collaborators

Lead sponsor

Şensu Dinçer

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 16, 2022
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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