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OpenTrials
Completed

NCT Number: NCT04785781

Effects of Face Masks on Cardiopulmonary Capacity in Healthy Individuals

The aim of our study is to compare the effects of face masks on cardiopulmonary capacity in young healthy individuals. The results of our study will show the effects of face masks commonly used during the pandemic period.

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Key information

Conditions

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

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University

Denizli, Turkey (Türkiye)

About this study

The aim of our study is to compare the effects of face masks on cardiopulmonary capacity in young healthy individuals. The results of our study will show the effects of face masks commonly used during the pandemic period.

The hypotheses we will test for this purpose; H1: face masks affect cardiopulmory capacity in healthy individuals H2: face masks affect heart rate in health individuals H3: face masks affect oxygen saturation in healthy individuals H4: face masks affect respiratory frequency in healthy individuals

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18 years old to 30
  • healthy young individuals

Exclusion criteria

  • having cardiovasculary conditions
  • having respiratory conditions
  • having inflammatory conditions
  • any contraindicated situations for cardiopulmonary tests

Treatment and study plan

without masks

Other

apply a bicycle ergometer test protocol to individuals without a mask

Surgical face mask (Vheal Med Co., Ltd., Istanbul, Turkey)

Other

apply a bicycle ergometer test protocol to individuals with a surgical mask

FFP2\N95 protective face mask (Musk protective technology, Gaziantep, Turkey)

Other

apply a bicycle ergometer test protocol to individuals with a FFP2\\N95 mask

Primary outcomes

  1. time to exhaustion

    Time frame: 5-10 minutes

    individuals perform cardiopulmonary capacity test with cycle ergometer till voluntary exhaustion

  2. Mask comfort/discomfort

    Time frame: 5-10 minutes

    Mask comfort/discomfort will be assesed by published questionnaire quantify the following ten domains of comfort/discomfort of wearing a mask: humidity, heat, breathing resistance, itchiness, tightness, saltiness, feeling unfit, odor, fatigue, and overall discomfort

Secondary outcomes

  1. heart rate

    Time frame: 1 minute

    heart rate before and after test

  2. oxygen saturation

    Time frame: 1 minute

    oxygen saturation via pulse oximeter before and after test

  3. respiratory frequency

    Time frame: 1 minute

    Respiratory rate measured within 1 minute before and after the test

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 8, 2021
Registry last updated
Mar 23, 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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