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Respiratory Pattern Change in Runners by Respiratory Tract Restriction Using a Respirator

U

University of South Bohemia

Status

Completed

Conditions

Breathing Pattern

Treatments

Diagnostic Test: Bruce test

Study type

Interventional

Funder types

Other

Identifiers

NCT07032740
USouthBohemia

Details and patient eligibility

About

This study involves 20 race runners (10 girls and 10 boys) aged 16-26. The investigators looked at the effect of the respirator on their respiratory function and the involvement of individual breath sectors. The order of the tests was randomly divided, each taking a test with and without a respirator.

Full description

Participants in this study were race runners. The inclusion criteria required participants to be between 16 and 26 years of age, free from any injuries, and able to provide full written informed consent. Exclusion criteria included smoking or the presence of any chronic pulmonary or cardiac disease, ensuring that the study focused solely on a healthy, homogenous population of physically active individuals.

Ethical Approval Prior to the measurements, all participants signed an informed consent form. The research was carried out with the consent of the Ethics Committee, Faculty of Education, University of South Bohemia, Ref. No.: EK031/2023. All procedures performed in the study were in accordance with the ethical standards of the institutional research committee and with the Helsinki declaration.

Measures, Design and Procedures Participants visited the laboratory twice to complete GXT (graded exercise tests) with the use of OEP (pto-electronic plethysmography). The time period between testing days was 72 hours. Participants were randomly (randomizer.org) split into two groups. The first group performed tests using FFR and the second without the mask. On the second visit, participants crossed over to the other condition. The N95 respirator (Promedor24, Czech Republic) was used for the study as a gold standard in protecting against aerosol transfer during the COVID-19 pandemic. New masks were used for each test. During GXT, data from OEP were collected from the last minute of each three minute stage.

Opto-electronic plethysmography An analysis of the breathing pattern and chest wall compartment volumes was performed using opto-electronic plethysmography (BTS Bioengineering, Milan, Italy). The system involves eight cameras (five positioned anterior and three posterior to the participant) and 89 reflective markers which were placed on the subject's chest, abdomen and back in order to map the subject's trunk. This technique has been shown to be valid at rest and during maximal exercise.

The contributions of each breathing compartment (VRCp- pulmonary rib cage, VRCa- abdominal rib cage, VAb- abdomen) were determined using the difference between end-inspiratory and end-expiratory volume. The exact method of calculating chest wall kinematics with OEP has been described in prior work.

Graded Exercise Tests To complete this study, participants were asked to complete two maximal graded exercise tests (GXT) on separate days, with and without FFR. After three minutes of walking warm-up (2.7 km·h-1, 10% incline), participants completed a Bruce protocol to exhaustion (see Table 1). Bruce protocol was performed on a treadmill (Lode Valiant 2 Sport, Lode B.V., Groningen, Netherlands). All tests were carried out at the same time of day to minimize the effects of circadian rhythms.

Table 1. The number of participants in each stage of GXT. Stage Speed (km·h-1) Incline (%) Masked Unmasked

  1. 2.7 10 21 21
  2. 4.0 12 21 21
  3. 5.4 14 20 21
  4. 6.7 16 18 18
  5. 8.0 18 8 13
  6. 8.8 20 0 2

Enrollment

20 patients

Sex

All

Ages

16 to 26 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • age
  • regular running training at least six times a week
  • full limit for national championship

Exclusion criteria

  • smoking
  • presence of any chronic pulmonary or cardiac d

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

20 participants in 2 patient groups

With respirator
Experimental group
Description:
The group of runners performed a test with a respirator.
Treatment:
Diagnostic Test: Bruce test
Without respirator
Active Comparator group
Description:
The group runners performed a test without a respirator.
Treatment:
Diagnostic Test: Bruce test

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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