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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05401331
Other study ID # Mask and Hemodynamic Responses
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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