Effect of Mask Use on Hemodynamic Responses During Exertion

NCT05401331 | Completed

• 1 other identifier: Mask and Hemodynamic Responses
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Dyspnea; Mask; Oxygen Saturation; Blood Pressure; Heart Rate; Exercise Test; COVİD-19

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

Hemodynamic changes due to mask use

OTHER

Hemodynamic changes due to mask use

Device: Treadmilll; Other: mask

Hemodynamic responses when we do not use masks

OTHER

Hemodynamic responses when we do not use masks

Device: Treadmilll

Interventions

Treadmilll DEVICE

Hemodynamic changes before and after treadmill use

Also known as: Saturation device, Sphygmomanometer

Hemodynamic changes due to mask use; Hemodynamic responses when we do not use masks

mask OTHER

mask

Hemodynamic changes due to mask use

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Volunteering to work,
• To be healthy,
• age range.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

University of Health Sciences

Istanbul, 00034, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19; Dyspnea

Interventions

Sphygmomanometers; Masks

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Surgical Attire; Equipment and Supplies, Hospital; Protective Devices; Personal Protective Equipment; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: June 2, 2022
• Study Start: April 1, 2022
• Primary Completion: May 1, 2022
• Study Completion: June 10, 2022
• Last Updated: August 30, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)