- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06175286
Effect of a Respiratory Training Program on Woodwind and Brass Players
February 2, 2024 updated by: MARIO ALEXANDRE GONÇALVES LOPES, Aveiro University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Aveiro, Portugal, 3810
- Escola Superior de Saúde da Universidade de Aveiro
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 18 years of age or over
- 10 years of musical experience
Exclusion Criteria:
- lung disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Subjects will carry on with their normal daily life
|
|
|
Experimental: POWERBreath
Subjects will train with the POWERBreath twice per day, for 30 continous breaths
|
30 inspirations with the POWERBreath Plus Medium Resistance training device, twice per day for 5 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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")
|
5 weeks
|
|
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).
|
5 weeks
|
|
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")
|
5 weeks
|
|
surface electromyography (sEMG)
Time Frame: 5 weeks
|
sEMG od the scalene, sternocleidomastoid, diaphragm and abdominal muscle activity (units of measure: millivolts)
|
5 weeks
|
|
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)
|
5 weeks
|
|
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)
|
5 weeks
|
|
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: %).
|
5 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Catarina Monteiro, University of Aveiro
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Arend 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2023
Primary Completion (Actual)
June 30, 2023
Study Completion (Actual)
June 30, 2023
Study Registration Dates
First Submitted
November 24, 2023
First Submitted That Met QC Criteria
December 5, 2023
First Posted (Actual)
December 18, 2023
Study Record Updates
Last Update Posted (Actual)
February 5, 2024
Last Update Submitted That Met QC Criteria
February 2, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- Musician respiratory training
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data will be shared upon fundamented request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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