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Effect of Mask Use on Hemodynamic Responses During Exertion

Sponsor
Saglik Bilimleri Universitesi (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05401331
Collaborator
(none)
52
Enrollment
1
Location
2
Arms
2
Anticipated Duration (Months)
25.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Treadmilll
  • Other: mask
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
52 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Effect of Mask Use on Hemodynamic Responses During Exertion
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Hemodynamic changes due to mask use

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

    Hemodynamic responses when we do not use masks

    Device: Treadmilll
    Hemodynamic changes before and after treadmill use
    Other Names:
  • Saturation device
  • Sphygmomanometer

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 25 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Health Sciences Istanbul Turkey 00034

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Saglik Bilimleri Universitesi
    ClinicalTrials.gov Identifier:
    NCT05401331
    Other Study ID Numbers:
    • Mask and Hemodynamic Responses
    First Posted:
    Jun 2, 2022
    Last Update Posted:
    Jun 2, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Saglik Bilimleri Universitesi
    Dyspnea
    Mask
    Oxygen Saturation
    Blood Pressure
    Heart Rate
    Exercise Test
    COVİD-19
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Jun 2, 2022