Effect of Mask Use on Hemodynamic Responses During Exertion

NCT05401331 — Not applicable, Completed, 52 participants, Saglik Bilimleri Universitesi

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Registry	NCT05401331
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, crossover, masking: none, screening
Enrollment	52 (Actual)
Sponsor	Saglik Bilimleri Universitesi (Other)
Conditions	COVID-19, Heart Rate, Blood Pressure, Exercise Test, Mask
Interventions	Treadmilll, mask (Device, other)
Dates	start 2022-04-01, primary completion 2022-05-01, completion 2022-06-10, first posted 2022-06-02, last updated 2022-08-30
Locations	1 site in Turkey (Türkiye)

-Summary

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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+Detailed description

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

+Arms and interventions

Arm	Type	Interventions	Description
Hemodynamic changes due to mask use	Other	Device: Treadmilll; Other: mask	Hemodynamic changes due to mask use
Hemodynamic responses when we do not use masks	Other	Device: Treadmilll	Hemodynamic responses when we do not use masks

Treadmilll (Device), also known as Saturation device, Sphygmomanometer: Hemodynamic changes before and after treadmill use
mask (Other): mask

+Outcome measures

Primary outcomes

Measurement of blood pressure changes due to mask use [The period in which each participant is evaluated by taking the outcome criterion is 30-60 minutes.]: Blood pressure reading with sphygmomanometer.
Evaluation of dyspnea score [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.
Evaluation of the degree of perceived fatigue [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.
Measurement of oxygen saturation and heart rate changes due to mask use [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.

+Eligibility

Sex: All, ages: 18 Years to 25 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
University of Health Sciences	Istanbul	Turkey (Türkiye)

+Investigators

Gülşah Karabıyık, Principal investigator, Saglik Bilimleri Universitesi
Ayşegül Tunç, Principal investigator, Saglik Bilimleri Universitesi
Zeynep Tanrıverdi, Principal investigator, Saglik Bilimleri Universitesi
Selen Öztürk, Principal investigator, Saglik Bilimleri Universitesi
Fulya Senem Karaahmetoğlu, Principal investigator, Saglik Bilimleri Universitesi
Halit Çınarka, Principal investigator, Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital