Effect of Mask Use on Hemodynamic Responses During Exertion

COVID-19 Clinical Trial

Official title:

Effect of Mask Use on Hemodynamic Responses During Exertion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05401331
• Other study ID #: Mask and Hemodynamic Responses
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: June 10, 2022

Study information

• Verified date: February 2022
• Source: Saglik Bilimleri Universitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 10, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure
• COVID-19
• Exercise Test
• Heart Rate
• Mask

Intervention

Device:
• Treadmilll
Hemodynamic changes before and after treadmill use

Other:
• mask
mask

Locations

Country	Name	City	State
Turkey	University of Health Sciences	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.