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Completed

NCT Number: NCT05401331

Effect of Mask Use on Hemodynamic Responses During Exertion

The use of masks is a necessity due to the current pandemic conditions. The aim of the study is to examine the effects of the use of masks during effort on dyspnea and fatigue with hemodynamic parameters.

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Key information

Conditions

COVID-19 Blood Pressure Coronaviridae Infections Coronavirus Infections Dyspnea Exercise Test Heart Rate Infections Lung Diseases Mask Nidovirales Infections Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory Virus Diseases

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences

Istanbul, 00034, Turkey (Türkiye)

About this study

The use of masks is a necessity due to the current pandemic conditions.There are studies on many parameters such as the effect of mask use on saturation (sp02), heart rate (HR) and blood pressure (BP). To determine whether there is a change in the performance of individuals in the masked and unmasked exercise test during exertion due to the scarcity of masked and unmasked maximal exercise tests and the insufficient measurement of the degree of fatigue felt, and to determine whether there is a change in the performance of individuals with and without mask, and to determine the hemodynamic responses in the body together with dyspnea and felt fatigue. This study will be conducted in order to examine the effect on

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Volunteering to work,
  • To be healthy,
  • 18-25 age range.

Exclusion criteria

  • Unstabil angina pectoris,
  • Atrial arrhythmia,
  • Uncontrollable asthma,
  • Pa02 < 50 mmHg,
  • PaCO2> 70mmHg,
  • Individuals with valve disease
  • Tachycardia, bradycardia,
  • Individuals with a resting systolic blood pressure of 200 mmHg
  • Smoking,
  • Presence of effective clinical conditions such as nasal deviation.

Treatment and study plan

Treadmilll

Device

Hemodynamic changes before and after treadmill use

Other names: Saturation device, Sphygmomanometer

mask

Other

mask

Primary outcomes

  1. Measurement of blood pressure changes due to mask use

    Time frame: The period in which each participant is evaluated by taking the outcome criterion is 30-60 minutes.

    Blood pressure reading with sphygmomanometer.

  2. Evaluation of dyspnea score

    Time frame: The period in which each participant is evaluated by taking the outcome criterion is 30-60 minutes.

    Dyspnea score was evaluated with the Modified Borg Scale. The Modified Borg Scale is a 0 to 10 numerical score used to measure dyspnea. 0 indicates minimum dyspnea and 10 indicates maximum dyspnea.

  3. Evaluation of the degree of perceived fatigue

    Time frame: The period in which each participant is evaluated by taking the outcome criterion is 30-60 minutes.

    The degree of perceived fatigue was evaluated with the Modified Borg Scale. The Modified Borg Scale was used to assess perceived difficulty. The Modified Borg Scale is a numerical score from 0 to 10. 0 means minimum difficulty and 10 means maximum difficulty.

  4. Measurement of oxygen saturation and heart rate changes due to mask use

    Time frame: The period in which each participant is evaluated by taking the outcome criterion is 30-60 minutes.

    Oxygen saturation and heart rate were recorded with a pulseoximetry device.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 2, 2022
Registry last updated
Aug 30, 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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