Clinical Trials Logo

Clinical Trial Summary

The purpose of this study was to compare breathing pattern and involvement of individual breathing compartments (IBC) with and without filtering facepiece respirator (FFR) during rest and exercise.


Clinical Trial Description

The study involved 21 students majoring in physical education and sports. All subjects were physically active, engaging in approximately 260 minutes of physical activity per week, and they possessed a high level of fitness. Inclusion criteria required participants to be free from injury, capable of providing written consent, and within the age range of 19 to 26 years. Exclusion criteria included individuals who smoked or had chronic pulmonary or cardiac diseases. This research received approval from the Ethics Committee at the Faculty of Education, University of South Bohemia, Reference Number: 002/2018. All procedures conducted within the study adhered to the ethical standards outlined by the Institutional Research Committee and the principles of the Helsinki Declaration. Protocol: Participants were instructed to visit the laboratory on two occasions to complete two separate tests during each session, specifically the Opto-electronic plethysmography (OEP) test during resting in a standing position and the OEP test during a Graded Exercise Test (GXT). The time interval between the testing days was three days. Participants were randomly assigned to two groups using randomizer.org. The first group performed three tests while wearing a Face-Fit Respirator (FFR), while the second group performed the tests without the mask. During the second visit, participants switched to the opposite condition. The N95 respirator was employed in this study as the gold standard for protection against aerosol transmission, particularly during the COVID-19 pandemic. A new mask was used for each test. In the Standing Test (STD), participants were instructed to maintain a stationary standing position and engage in spontaneous, quiet breathing without speaking or altering their posture while OEP data was collected. The first two minutes were designated as an adaptation period, followed by data collection for an additional three minutes. In the context of the Graded Exercise Test (GXT), OEP data was collected during the final minute of each three-minute stage. Opto-Electronic Plethysmography: The analysis of breathing patterns and volumes of chest wall compartments was conducted using opto-electronic plethysmography (BTS Bioengineering, Milan, Italy). This device comprises eight cameras, with five positioned anteriorly and three posteriorly relative to the participant. Additionally, 89 reflective markers were affixed to the participant's chest, abdomen, and back to track movements of the trunk. This technique has previously demonstrated validity in both resting and maximal exercise conditions. The contributions of each breathing compartment (VRCp - pulmonary rib cage, VRCa - abdominal rib cage, VAb - abdomen) were determined by calculating the difference between end-inspiratory and end-expiratory volumes. The specific methodology for calculating chest wall kinematics using OEP has been detailed in prior research. Graded Exercise Tests: To complete this study, participants were required to undergo two maximal graded exercise tests (GXT) on separate days, one with the use of a Face-Fit Respirator (FFR) and one without. After three minutes of warm-up walking (2.7 km/h, 10% incline), participants performed the Bruce Protocol until exhaustion. The Bruce Protocol was conducted on a treadmill (Lode Valiant 2 Sport, Lode B.V., Groningen, Netherlands). All tests were conducted at the same time of day to mitigate the influence of circadian rhythms. Immediately following the completion of the test, participants provided ratings on the Modified Borg Dyspnea Scale, which ranges from 0 to 10, to assess breathlessness. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06053502
Study type Observational
Source University of South Bohemia
Contact
Status Completed
Phase
Start date January 2, 2023
Completion date August 26, 2023

See also
  Status Clinical Trial Phase
Completed NCT03946137 - Chest Therapy and Postural Education in Children With Cerebral Palsy N/A
Recruiting NCT06089226 - Parameters Related to Physical Activity Level in SCI
Completed NCT03931902 - The Comparison of Laryngeal Mask Airway and Endotracheal Tube in General Anesthesia for Premature Neonates N/A
Completed NCT03105739 - Timing of Withdrawal of the Laryngeal Mask Airway (LMA) in Children N/A
Recruiting NCT04100512 - Oscillating Positive Expiratory Pressure (OPEP) Therapy in Trauma Patients With Multiple Rib Fractures N/A
Enrolling by invitation NCT06360666 - Clinical Outcomes in Adult Patients Undergoing Laparoscopic Surgery Under Neuraxial Anesthesia
Recruiting NCT06149494 - RCT of Vapendavir in Patients With COPD and Human Rhinovirus/Enterovirus Upper Respiratory Infection Phase 2
Completed NCT03056885 - Inflammatory Local Response During OLV: Protective vs Conventional Ventilation Strategy N/A
Recruiting NCT05136781 - DEXAMETHASONE for Non-urgent Thoracic Surgery
Terminated NCT03665259 - Lower Inspiratory Oxygen Fraction for Preoxygenation N/A
Not yet recruiting NCT03255356 - Ventilation in Cardiac Surgery N/A
Terminated NCT03571646 - LIFEGUARD Study - Continuous Respiratory Monitoring on the General Ward N/A
Not yet recruiting NCT05363098 - The Cerebral-Respiratory Interaction During Spontaneous Breathing Ventilation in Neurosurgical Patients (CeRes-SB)
Recruiting NCT03969147 - Investigation of a Novel Oropharyngeal Airway: The ManMaxAirway N/A
Completed NCT03218215 - Monitoring Mechanical Assisted Cough N/A
Completed NCT03102619 - Wireless Assessment of Respiratory and Circulatory Distress; A Pilot Study N/A
Recruiting NCT05804175 - Advanced Prediction of Respiratory Depression Episode With the Linshom Continuous Predictive Respiratory Sensor
Recruiting NCT06301126 - Virtual Reality on Pulmonary Function After Upper Abdominal Surgeries N/A
Recruiting NCT05354466 - Perioperative Respiratory Adverse events_sugammadex N/A
Recruiting NCT05856136 - A Study to Investigate of the Effects of Opioid Exposure on the Ability of the Diaphragm Muscle Phase 4