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Completed

NCT Number: NCT04498546

Mask Usage and Exercise During the COVİD-19 Pandemic

To determine the effect of using mask during exercise on exercise capacity and values measured before exercise (heart rate, blood pressure, peripheral oxygen saturation (SpO2), fatigue, severity of dyspnea, etc.). To investigate the haemodynamic effects (heart rate, blood pressure, peripheral oxygen saturation (SpO2), fatigue, dyspnea severity, etc.) of the mask, which entered daily life during the epidemic period and which requires long-term use, and examine the effect on hemodynamic stress.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

KTO Karatay University

Konya, Karatay, 42030, Turkey (Türkiye)

About this study

Surgical masks are frequently used after the necessity to use a mask in the community.The effects of technologically well-designed training masks used in athletes have been shown on hypoxia and heart rate responses during exercise, but there are no studies examining the exercise capacity and hemodynamic responses given to exercise in healthy normal individuals.This study is planned to evaluate the effects of the use of surgical masks that are widespread in the community due to pandemic on the exercise capacity and exercise responses (heart rate, blood pressure, peripheral oxygen saturation, fatigue).

Exercise tests will be carried out for each individual randomly, twice with a mask and without a mask. The materials used before and after each exercise test will be sterilized. During the exercise test, individual antibacterial filters will be used for each person.Bruce protocol will be used to determine exercise capacity.

Who can participate

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

Inclusion criteria

  • Volunteering to be included in the research,
  • Being between the ages of 18-65,
  • Having physical fitness to do exercise tests,
  • Having a cognitive function that will allow active participation in the exercise test.
  • No chronic illness.

Exclusion criteria

  • Not to volunteer to participate in the research,
  • Having any mental or physical condition that impedes performing exercise tests,
  • Having any of the symptoms of COVID-19,
  • Having been diagnosed with COVID-19 before,
  • Having a history of contact with COVID-19 patient
  • Having a cardiac, neurological, orthopedic and respiratory disease
  • Use of assistive devices while walking

Treatment and study plan

Primary outcomes

  1. Resting Heart Rate

    Time frame: baseline

    Resting Heart Rate beats/min

  2. Peak Heart Rate

    Time frame: During the procedure

    Peak Heart Rate beats/min

  3. Recovery Heart Rate

    Time frame: Immediately after the procedure

    Recovery Heart Rate beats/min

  4. Resting systolic blood pressure

    Time frame: baseline

    Resting systolic blood pressure mmHg

  5. Recovery systolic blood pressure

    Time frame: Immediately after the procedure

    Recovery systolic blood pressure mmHg

  6. Resting diastolic blood pressure

    Time frame: Baseline

    Resting diastolic blood pressure mmHg

  7. Recovery diastolic blood pressure

    Time frame: Immediately after the procedure

    Recovery diastolic blood pressure mmHg

  8. Peripheral oxygen saturation

    Time frame: Baseline

    To be measured by Pulse Oximeter (SpO2) To be measured by Pulse Oximeter (SpO2)

  9. Peripheral oxygen saturation

    Time frame: Immediately after the procedure

    To be measured by Pulse Oximeter (SpO2)

  10. VO2max

    Time frame: Baseline

    Maximal Oxygen Consumption (ml/kg/dk). Gas analyzer measuring breath to breath will be used.

Secondary outcomes

  1. Dyspnoea Severity

    Time frame: Baseline

    It will be measured with a 20-point borg scale. As the score increases, the severity of dyspnea increases

  2. Dyspnoea Severity

    Time frame: Immediately after the procedure

    It will be measured with a 20-point borg scale. As the score increases, the severity of dyspnea increases

Sponsors and collaborators

Lead sponsor

KTO Karatay University

Other

Registry information

Official study title

The Effects of Mask Usage on Exercise Capacity and Related Parameters During the COVİD-19 Pandemic

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 4, 2020
Registry last updated
Apr 7, 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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