Respiratory FunctionNCT06175286
Effect of a Respiratory Training Program on Woodwind and Brass Players
A study testing POWERBreath Plus Medium Resistance training device in people with Respiratory Function, run by Aveiro University at 1 site in Portugal.
Trial summary
This project will study the effect of a respiratory training program on woodwind and brass players, using an inspiratory muscle training equipment. The goal is to understand whether it is possible to develop the inspiratory muscles of wind players through regular and planned training. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Function
- What is being tested?
- POWERBreath Plus Medium Resistance training device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Apr 2023to 30 Jun 2023
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or over
- 10 years of musical experience
Who cannot join
- lung disease
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Escola Superior de Saúde da Universidade de Aveiro
Aveiro, 3810
About this study
This project will study the effect of a respiratory training program on woodwind and brass players, using an inspiratory muscle training equipment. The goal is to understand whether it is possible to develop the inspiratory muscles of wind players through regular and planned training. Fourteen young wind players will be selected, in which 7 will be male and 7 will be female, playing different instruments. Inspiratory muscle training will be performed with the POWERBreath Plus Medium Resistance, and will consist of 30 maximal inspirations, twice a day, for 5 weeks.
Read the detailed description
This project will study the effect of a respiratory training program on woodwind and brass players, using an inspiratory muscle training equipment. The goal is to understand whether it is possible to develop the inspiratory muscles of wind players through regular and planned training. Fourteen young wind players will be selected, in which 7 will be male and 7 will be female, playing different instruments: transverse flute (1), oboe (2), saxophone (4), horn (4), trumpet (1), trombone (1) and tuba (1). Inspiratory muscle training will be performed with the POWERBreath Plus Medium Resistance, and will consist of 30 maximal inspirations, twice a day, for 5 weeks. The participants will be instructed on the use, handling and cleaning of the equipment. The participants will be instructed to use the equipment in a comfortable position, with a good posture, and will be instructed on how they should execute the inspiratory training: inhale to the maximum limit, with intensity, and exhale slowly and relaxed. An explanation will also be given about the calibration of the POWERbreathe, and the initial resistance level will be established based on the calculation of 50% of the Maximal Inspiratory Pressure of each participant, previously measured. Participants will also be instructed on how to increase the resistance level of POWERbreathe. The increase would be 1/4 of a level, whenever they no longer feel tired after a 30-inhalation workout. A questionnaire will be applied before, during and after the inspiratory training and they will be asked to record the daily use of the equipment in an online form, created for the purpose of recording its use by each participant. Assessment will be executed with the standard Borg Scale and the modified Borg scale. Surface electromyography (sEMG) of the right sternocleidomastoid, the right scalene muscles, the diaphragm and the right rectus abdominis will also be tested. Maximal inspiratory pressure and spirometry testing, specifically volume of forced vital capacity (FVC) or forced expiratory volume in one second (FEV1) and FEV1/FVC ratio will also be assessed.
- Conditions
- Respiratory Function
- Being tested
- POWERBreath Plus Medium Resistance training device
- Keywords
- Inspiratory muscle training, lung capacity, musicians
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POWERBreath Plus Medium Resistance training deviceOther
30 inspirations with the POWERBreath Plus Medium Resistance training device, twice per day for 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| POWERBreath | Experimental | Subjects will train with the POWERBreath twice per day, for 30 continous breaths Receives: Other: POWERBreath Plus Medium Resistance training device |
| Control | No intervention | Subjects will carry on with their normal daily life |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum inspiratory pressure
Maximal inspiratory pressure (MIP) is an important and non-invasive index of diaphragm strength and an independent predictor of all-cause mortality (units of measure: (cmH2O).
Measured: 5 weeks
subjective physical effort
subjective physical effort, assessed with the Borg scale (scale: 6-20; 6= "Very, very light"; 20= "Very, very hard")
Measured: 5 weeks
dyspnea
subjective respiratory effort, assessed with the modified Borg scale (scale: 0-10; 0= "Nothing at all"; 10= "Very, very strong")
Measured: 5 weeks
surface electromyography (sEMG)
sEMG od the scalene, sternocleidomastoid, diaphragm and abdominal muscle activity (units of measure: millivolts)
Measured: 5 weeks
spirometry: Forced expiratory volume in one second (VEF1)
to assess lung function: the assessment of the forced expiratory volume in the fisrt second of the expiratory effort (units of measure: milliliters)
Measured: 5 weeks
spirometry: volume of forced vital capacity (FVC)
to assess lung function: the assessment of the total forced vital capacity (units of measure: milliliters)
Measured: 5 weeks
spirometry: ratio between VEF1 and FVC
the ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs. The normal value for this ratio is above 0.75-85 %, though this is age dependent (units of measure: %).
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start1 Apr 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory FunctionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARIO ALEXANDRE GONÇALVES LOPES, Aveiro University
- Investigators
- Catarina Monteiro, Principal investigator, University of Aveiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175286
- Sponsor's protocol ID
- Musician respiratory training
- Status last verified
- Feb 2024
- First submitted
- 24 Nov 2023
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared upon fundamented request.
Publications
Drinkwater EJ, Klopper CJ. Quantifying the physical demands of a musical performance and their effects on performance quality. Med Probl Perform Art. 2010 Jun;25(2):66-71.
PubMed 20795334Arend M, Kivastik J, Maestu J. Maximal inspiratory pressure is influenced by intensity of the warm-up protocol. Respir Physiol Neurobiol. 2016 Aug;230:11-5. doi: 10.1016/j.resp.2016.05.002. Epub 2016 May 12.
PubMed 27181328
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Respiratory Training Program on Woodwind and Brass Players
- ClinicalTrials.gov ID
- NCT06175286
- Acronym / sponsor ID
- Musician respiratory training
- Conditions
- Respiratory Function
- Keywords
- Inspiratory muscle training, lung capacity, musicians
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 18 Dec 2023 (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 project will study the effect of a respiratory training program on woodwind and brass players, using an inspiratory muscle training equipment. The goal is to understand whether it is possible to develop the inspiratory muscles of wind players through regular and planned training. Fourteen young wind players will be selected, in which 7 will be male and 7 will be female, playing different instruments. Inspiratory muscle training will be performed with the POWERBreath Plus Medium Resistance, and will consist of 30 maximal inspirations, twice a day, for 5 weeks.
Detailed description
This project will study the effect of a respiratory training program on woodwind and brass players, using an inspiratory muscle training equipment. The goal is to understand whether it is possible to develop the inspiratory muscles of wind players through regular and planned training. Fourteen young wind players will be selected, in which 7 will be male and 7 will be female, playing different instruments: transverse flute (1), oboe (2), saxophone (4), horn (4), trumpet (1), trombone (1) and tuba (1). Inspiratory muscle training will be performed with the POWERBreath Plus Medium Resistance, and will consist of 30 maximal inspirations, twice a day, for 5 weeks. The participants will be instructed on the use, handling and cleaning of the equipment. The participants will be instructed to use the equipment in a comfortable position, with a good posture, and will be instructed on how they should execute the inspiratory training: inhale to the maximum limit, with intensity, and exhale slowly and relaxed. An explanation will also be given about the calibration of the POWERbreathe, and the initial resistance level will be established based on the calculation of 50% of the Maximal Inspiratory Pressure of each participant, previously measured. Participants will also be instructed on how to increase the resistance level of POWERbreathe. The increase would be 1/4 of a level, whenever they no longer feel tired after a 30-inhalation workout. A questionnaire will be applied before, during and after the inspiratory training and they will be asked to record the daily use of the equipment in an online form, created for the purpose of recording its use by each participant. Assessment will be executed with the standard Borg Scale and the modified Borg scale. Surface electromyography (sEMG) of the right sternocleidomastoid, the right scalene muscles, the diaphragm and the right rectus abdominis will also be tested. Maximal inspiratory pressure and spirometry testing, specifically volume of forced vital capacity (FVC) or forced expiratory volume in one second (FEV1) and FEV1/FVC ratio will also be assessed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POWERBreath | Experimental | Other: POWERBreath Plus Medium Resistance training deviceSubjects will train with the POWERBreath twice per day, for 30 continous breaths |
| Control | No intervention | –Subjects will carry on with their normal daily life |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or over
- 10 years of musical experience
Key exclusion criteria (1 listed)
- lung disease
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 |
|---|---|---|
| POWERBreath Plus Medium Resistance training device30 inspirations with the POWERBreath Plus Medium Resistance training device, twice per day for 5 weeks | Other | POWERBreath |
Primary outcome
maximum inspiratory pressure
Time frame: 5 weeks
Maximal inspiratory pressure (MIP) is an important and non-invasive index of diaphragm strength and an independent predictor of all-cause mortality (units of measure: (cmH2O).
subjective physical effort
Time frame: 5 weeks
subjective physical effort, assessed with the Borg scale (scale: 6-20; 6= "Very, very light"; 20= "Very, very hard")
dyspnea
Time frame: 5 weeks
subjective respiratory effort, assessed with the modified Borg scale (scale: 0-10; 0= "Nothing at all"; 10= "Very, very strong")
surface electromyography (sEMG)
Time frame: 5 weeks
sEMG od the scalene, sternocleidomastoid, diaphragm and abdominal muscle activity (units of measure: millivolts)
spirometry: Forced expiratory volume in one second (VEF1)
Time frame: 5 weeks
to assess lung function: the assessment of the forced expiratory volume in the fisrt second of the expiratory effort (units of measure: milliliters)
spirometry: volume of forced vital capacity (FVC)
Time frame: 5 weeks
to assess lung function: the assessment of the total forced vital capacity (units of measure: milliliters)
spirometry: ratio between VEF1 and FVC
Time frame: 5 weeks
the ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs. The normal value for this ratio is above 0.75-85 %, though this is age dependent (units of measure: %).
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 5 Feb 2024.
- Background: PubMed 20795334Drinkwater EJ, Klopper CJ. Quantifying the physical demands of a musical performance and their effects on performance quality. Med Probl Perform Art. 2010 Jun;25(2):66-71.
- Results publication: PubMed 27181328Arend M, Kivastik J, Maestu J. Maximal inspiratory pressure is influenced by intensity of the warm-up protocol. Respir Physiol Neurobiol. 2016 Aug;230:11-5. doi: 10.1016/j.resp.2016.05.002. Epub 2016 May 12.
- Individual participant dataSharing planned: No. Data will be shared upon fundamented 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.
Catarina Monteiro principal investigator
University of Aveiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POWERBreath Plus Medium Resistance training device in people with Respiratory Function, run by Aveiro University at 1 site in Portugal.
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 2 inclusion and 1 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 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. 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?
maximum inspiratory pressure (time frame: 5 weeks). The study lists 7 primary outcomes in all. 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 NCT06175286, which also lists 2 linked publications.
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 5 Feb 2024.