Back to resultsEffect of Mask Use on Hemodynamic Responses During Exertion
Primary Purpose
COVID-19, Heart Rate, Blood Pressure
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Treadmilll
mask
Sponsored by
About this trial
This is an interventional screening trial for COVID-19 focused on measuring Dyspnea, Mask, Oxygen Saturation, Blood Pressure, Heart Rate, Exercise Test, COVİD-19
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.
Sites / Locations
- University of Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Hemodynamic changes due to mask use
Hemodynamic responses when we do not use masks
Arm Description
Hemodynamic changes due to mask use
Hemodynamic responses when we do not use masks
Outcomes
Primary Outcome Measures
Measurement of blood pressure changes due to mask use
Blood pressure reading with sphygmomanometer.
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.
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.
Measurement of oxygen saturation and heart rate changes due to mask use
Oxygen saturation and heart rate were recorded with a pulseoximetry device.
Secondary Outcome Measures
Full Information
NCT ID
NCT05401331
First Posted
April 11, 2022
Last Updated
August 25, 2022
Sponsor
Saglik Bilimleri Universitesi
1. Study Identification
Unique Protocol Identification Number
NCT05401331
Brief Title
Effect of Mask Use on Hemodynamic Responses During Exertion
Official Title
Effect of Mask Use on Hemodynamic Responses During Exertion
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
June 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saglik Bilimleri Universitesi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Heart Rate, Blood Pressure, Exercise Test, Mask
Keywords
Dyspnea, Mask, Oxygen Saturation, Blood Pressure, Heart Rate, Exercise Test, COVİD-19
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hemodynamic changes due to mask use
Arm Type
Other
Arm Description
Hemodynamic changes due to mask use
Arm Title
Hemodynamic responses when we do not use masks
Arm Type
Other
Arm Description
Hemodynamic responses when we do not use masks
Intervention Type
Device
Intervention Name(s)
Treadmilll
Other Intervention Name(s)
Saturation device, Sphygmomanometer
Intervention Description
Hemodynamic changes before and after treadmill use
Intervention Type
Other
Intervention Name(s)
mask
Intervention Description
mask
Primary Outcome Measure Information:
Title
Measurement of blood pressure changes due to mask use
Description
Blood pressure reading with sphygmomanometer.
Time Frame
The period in which each participant is evaluated by taking the outcome criterion is 30-60 minutes.
Title
Evaluation of dyspnea score
Description
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.
Time Frame
The period in which each participant is evaluated by taking the outcome criterion is 30-60 minutes.
Title
Evaluation of the degree of perceived fatigue
Description
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.
Time Frame
The period in which each participant is evaluated by taking the outcome criterion is 30-60 minutes.
Title
Measurement of oxygen saturation and heart rate changes due to mask use
Description
Oxygen saturation and heart rate were recorded with a pulseoximetry device.
Time Frame
The period in which each participant is evaluated by taking the outcome criterion is 30-60 minutes.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülşah Karabıyık
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ayşegül Tunç
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zeynep Tanrıverdi
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Selen Öztürk
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fulya Senem Karaahmetoğlu
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Halit Çınarka
Organizational Affiliation
Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Health Sciences
City
Istanbul
ZIP/Postal Code
00034
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Mask Use on Hemodynamic Responses During Exertion
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