Effect of Mask Use on Hemodynamic Responses During Exertion

Study Overview
=================
Brief 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.

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

Official Title
-----------------
Effect of Mask Use on Hemodynamic Responses During Exertion

Conditions
-----------------
Mask, COVID-19, Heart Rate, Blood Pressure, Exercise Test

Intervention / Treatment
-----------------
* Device: Treadmilll
* Other: mask


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Hemodynamic changes due to mask use<br>Hemodynamic changes due to mask use | Device: Treadmilll<br>* Hemodynamic changes before and after treadmill use<br>* Other names: Sphygmomanometer;Other: mask<br>* mask<br>|
| Other: Hemodynamic responses when we do not use masks<br>Hemodynamic responses when we do not use masks | Device: Treadmilll<br>* Hemodynamic changes before and after treadmill use<br>* Other names: Sphygmomanometer;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of blood pressure changes due to mask use | Blood pressure reading with sphygmomanometer. | The period in which each participant is evaluated by taking the outcome criterion is 30-60 minutes. | 
| Evaluation of dyspnea score | 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. | The period in which each participant is evaluated by taking the outcome criterion is 30-60 minutes. | 
| Evaluation of the degree of perceived fatigue | 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. | The period in which each participant is evaluated by taking the outcome criterion is 30-60 minutes. | 
| Measurement of oxygen saturation and heart rate changes due to mask use | Oxygen saturation and heart rate were recorded with a pulseoximetry device. | The period in which each participant is evaluated by taking the outcome criterion is 30-60 minutes. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dyspnea, Mask, Oxygen Saturation, Blood Pressure, Heart Rate, Exercise Test, COVİD-19