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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Blood Pressure; Heart Rate; Exercise Test; Mask
• Intervention / Treatment: Device: Treadmilll; Other: mask

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

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 00034
    • University of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NON_RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Hemodynamic changes due to mask use	Device: Treadmilll; Hemodynamic changes before and after treadmill use; Other Names: Saturation device; Sphygmomanometer; Other: mask; mask
OTHER: Hemodynamic responses when we do not use masks	Device: Treadmilll; Hemodynamic changes before and after treadmill use; Other Names: Saturation device; 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.

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi
• Investigators: Principal Investigator: Gülşah Karabıyık, Saglik Bilimleri Universitesi; Principal Investigator: Ayşegül Tunç, Saglik Bilimleri Universitesi; Principal Investigator: Zeynep Tanrıverdi, Saglik Bilimleri Universitesi; Principal Investigator: Selen Öztürk, Saglik Bilimleri Universitesi; Principal Investigator: Fulya Senem Karaahmetoğlu, Saglik Bilimleri Universitesi; Principal Investigator: Halit Çınarka, Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2022
• Primary Completion (ACTUAL): May 1, 2022
• Study Completion (ACTUAL): June 10, 2022

Study Registration Dates

• First Submitted: April 11, 2022
• First Submitted That Met QC Criteria: May 28, 2022
• First Posted (ACTUAL): June 2, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 30, 2022
• Last Update Submitted That Met QC Criteria: August 25, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Blood Pressure; Dyspnea; Mask; Heart Rate; Exercise Test; Oxygen Saturation; COVİD-19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Mask and Hemodynamic Responses

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No