Effect of Mask Use on Hemodynamic Responses During Exertion

Not Applicable

Completed

• Conditions: COVID-19; Heart Rate; Blood Pressure; Exercise Test; Mask
• Interventions: Device: Treadmilll; Other: mask

• Registration Number: NCT05401331
• Lead Sponsor: Saglik Bilimleri Universitesi

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

Study Timeline

• Status Verified: 2022-02
• Study Start: 2022-04-01
• Study First Submitted: 2022-04-11
• Primary Completion: 2022-05-01
• Study First Submitted QC: 2022-05-28
• Study First Posted: 2022-06-02
• Study Completion: 2022-06-10
• Last Update Submitted: 2022-08-25
• Last Update Posted: 2022-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hemodynamic responses when we do not use masks	Treadmilll	Hemodynamic responses when we do not use masks
Hemodynamic changes due to mask use	mask	Hemodynamic changes due to mask use
Hemodynamic changes due to mask use	Treadmilll	Hemodynamic changes due to mask use

Primary Outcome Measures

Name	Time	Method
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 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.
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.
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.

Trial Locations

Locations (1)

University of Health Sciences; 🇹🇷 Istanbul, Turkey