Breathing PatternNCT07032740
Respiratory Pattern Change in Runners by Respiratory Tract Restriction Using a Respirator
A study testing Bruce test in people with Breathing Pattern, run by University of South Bohemia at 2 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Breathing Pattern
- What is being tested?
- Bruce test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesCzechia
- Study dates
- 15 Jan 2025to 24 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 26 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- age
- regular running training at least six times a week
- full limit for national championship
Who cannot join
- smoking
- presence of any chronic pulmonary or cardiac d
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites
University of South Bohemia
České Budějovice, 37001
University of South Bohemia
České Budějovice, 37005
About this study
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.
Read the 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
- 2.7 10 21 21
- 4.0 12 21 21
- 5.4 14 20 21
- 6.7 16 18 18
- 8.0 18 8 13
- 8.8 20 0 2
- Conditions
- Breathing Pattern
- Being tested
- Bruce test
- Keywords
- optoelectronic plethysmography, N95, graded exercise test, abdominal compartment, chest wall compartments, FFR, face mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bruce testDiagnostic test
In the Bruce test, a breath pattern was obtained by means of an OEP (once with a respirator and once without a respirator).
| Study group | Role | What they receive |
|---|---|---|
| With respirator | Experimental | The group of runners performed a test with a respirator. Receives: Diagnostic Test: Bruce test |
| Without respirator | Active comparator | The group runners performed a test without a respirator. Receives: Diagnostic Test: Bruce test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breathing pattern with and without using a respirator
Respiratory sector involvement ratio during Bruce test with using a respirator and without using a respirator
Measured: Day 1 - first test, day 4 (after 72 hours) - second test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start15 Jan 2025
- Primary completion10 May 2025
- Study completion24 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breathing PatternStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant underwent both tests, with and without respirators, in random order.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Bohemia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petr Bahensky, University of South Bohemia
- Investigators
- David Marko, Study chair, University of South Bohemia in České Budějovice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032740
- Sponsor's protocol ID
- USouthBohemia
- Status last verified
- Jun 2025
- First submitted
- 27 May 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data associated with the paper are not publicly available but are available from the corresponding author on reasonable request.
Publications
Bahensky P, Mrkvicka T, Marko D, Malatova R, Krajcigr M, Harbour E. Respiratory pattern change in female and male runners by respiratory tract restriction using a respirator. PLoS One. 2026 Jul 16;21(7):e0353784. doi: 10.1371/journal.pone.0353784. eCollection 2026.
PubMed 42461925
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Pattern Change in Runners by Respiratory Tract Restriction Using a Respirator
- ClinicalTrials.gov ID
- NCT07032740
- Acronym / sponsor ID
- USouthBohemia
- Conditions
- Breathing Pattern
- Keywords
- optoelectronic plethysmography, N95, graded exercise test, abdominal compartment, chest wall compartments, FFR, face mask
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of South BohemiaUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 10 May 2025 (actual)
- Study completion
- 24 May 2025 (actual)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 2.7 10 21 21
- 4.0 12 21 21
- 5.4 14 20 21
- 6.7 16 18 18
- 8.0 18 8 13
- 8.8 20 0 2
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Each participant underwent both tests, with and without respirators, in random order.
| Arm | Type | Receives |
|---|---|---|
| With respirator | Experimental | Diagnostic Test: Bruce testThe group of runners performed a test with a respirator. |
| Without respirator | Active comparator | Diagnostic Test: Bruce testThe group runners performed a test without a respirator. |
Who may qualify
- Ages
- 16 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- age
- regular running training at least six times a week
- full limit for national championship
Key exclusion criteria (2 listed)
- smoking
- presence of any chronic pulmonary or cardiac d
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bruce testIn the Bruce test, a breath pattern was obtained by means of an OEP (once with a respirator and once without a respirator). | Diagnostic test | With respirator, Without respirator |
Primary outcome
Breathing pattern with and without using a respirator
Time frame: Day 1 - first test, day 4 (after 72 hours) - second test
Respiratory sector involvement ratio during Bruce test with using a respirator and without using a respirator
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Derived from this study: PubMed 42461925Bahensky P, Mrkvicka T, Marko D, Malatova R, Krajcigr M, Harbour E. Respiratory pattern change in female and male runners by respiratory tract restriction using a respirator. PLoS One. 2026 Jul 16;21(7):e0353784. doi: 10.1371/journal.pone.0353784. eCollection 2026.
- Individual participant dataSharing planned: Yes. The data associated with the paper are not publicly available but are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Marko study chair
University of South Bohemia in České Budějovice
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bruce test in people with Breathing Pattern, run by University of South Bohemia at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breathing pattern with and without using a respirator (time frame: Day 1 - first test, day 4 (after 72 hours) - second test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07032740, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.