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

NCT ID: NCT07032740

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-15
• Study Completion Date: 2025-05-24

Brief Summary

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.

Detailed 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

Conditions

Breathing Pattern

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

With respirator

The group of runners performed a test with a respirator.

Group Type: EXPERIMENTAL

Bruce test

Intervention Type: DIAGNOSTIC_TEST

In the Bruce test, a breath pattern was obtained by means of an OEP (once with a respirator and once without a respirator).

Without respirator

The group runners performed a test without a respirator.

Group Type: ACTIVE_COMPARATOR

Bruce test

Intervention Type: DIAGNOSTIC_TEST

In the Bruce test, a breath pattern was obtained by means of an OEP (once with a respirator and once without a respirator).

Interventions

Bruce test

In the Bruce test, a breath pattern was obtained by means of an OEP (once with a respirator and once without a respirator).

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of South Bohemia

OTHER

Sponsor Role: lead

Responsible Party

Petr Bahensky

Head of Laboratory

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Marko

Role: STUDY_CHAIR

University of South Bohemia in České Budějovice

Locations

University of South Bohemia

České Budějovice, , Czechia

University of South Bohemia

České Budějovice, , Czechia

Countries

Czechia

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

USouthBohemia

Identifier Type: -

Identifier Source: org_study_id