Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615001317583
Ethics application status
Approved
Date submitted
8/09/2015
Date registered
2/12/2015
Date last updated
2/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Respiratory Muscle Training in saxophone players
Scientific title
In healthy saxophone players, does a respiratory muscle training program increase maximum inspiratory and expiratory pressure, peak inspiratory and expiratory flow, lung volumes, flow used while playing the saxophone and playing comfort?
Secondary ID [1] 287426 0
None
Universal Trial Number (UTN)
U1111-1174-0787
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
inspiratory and expiratory muscle training in healthy saxophone players 296137 0
Condition category
Condition code
Respiratory 296405 296405 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
6 week training program with a pressure threshold breathing device designed for a combination of inspiratory and expiratory muscle training. The device is a small handheld device which exerts a pressure against inspiration and expiration. The SHAM training (6 weeks) consisted of a training routine with resistance levels set at 15% of maximum inspiratory and expiratory pressures at baseline. 5 days a week a set of 40 breaths (4 times 10 breaths), two times daily, followed by 2 days of non activity. Inspiration to total lung capacity, exhalation to functional residual capacity. Adherence, time spend and exertion was monitored with a diary. This was followed immediately (no washout period) by a real training program (6 weeks) consisting of the same training routine, with resistance set at 60% of maximum inspiratory and maximum expiratory pressures measured after SHAM training.
Intervention code [1] 292785 0
Treatment: Devices
Comparator / control treatment
SHAM (resistance of respiratory threshold loaded breathing device at 15% of maximum inspiratory pressure and maximum expiratory pressure)
Control group
Placebo

Outcomes
Primary outcome [1] 296046 0
This is a composite primary outcome. Maximum inspiratory and expiratory pressures as assessed by spirometry.
Timepoint [1] 296046 0
Baseline, after SHAM training, after real training
Secondary outcome [1] 317348 0
Change of flow use during saxophone performance (measured using an adapted saxophone neck which enables flow measurements during saxophone performance).
Timepoint [1] 317348 0
Baseline, after SHAM training, after real training
Secondary outcome [2] 317349 0
Change in playing comfort (using a questionnaire designed specifically for this study).
Timepoint [2] 317349 0
Baseline, after SHAM training, after real training
Secondary outcome [3] 317350 0
Peak inspiratory and expiratory flows and lung volumes as assessed by spirometry.
Timepoint [3] 317350 0
Baseline, after SHAM training, after real training
Secondary outcome [4] 318939 0
The spectral centroid and RMS of the sound were determined through recording and analysis of the sound files.
Timepoint [4] 318939 0
Baseline, after SHAM, after real training

Eligibility
Key inclusion criteria
experienced saxophone players (at least 4 years of playing experience)
Minimum age
16 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
respiratory disease, smokers

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nonrandomised trial
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/11/2014
Actual
27/11/2014
Date of last participant enrolment
Anticipated
Actual
19/03/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
16
Recruitment outside Australia
Country [1] 7148 0
Belgium
State/province [1] 7148 0

Funding & Sponsors
Funding source category [1] 292002 0
Charities/Societies/Foundations
Name [1] 292002 0
Fonds voor Wetenschappelijk Onderzoek Vlaanderen
Country [1] 292002 0
Belgium
Primary sponsor type
Individual
Name
Koen Dries
Address
Koen Dries
Vrije Universiteit Brussel
Kuilstraat 3
2480 Dessel
Country
Belgium
Secondary sponsor category [1] 290665 0
Hospital
Name [1] 290665 0
UZ Brussel
Address [1] 290665 0
UZ Brussel
Laerbeeklaan 101
1090 Brussels
Country [1] 290665 0
Belgium
Secondary sponsor category [2] 290666 0
University
Name [2] 290666 0
Koninklijk Conservatorium Brussel
Address [2] 290666 0
Koninklijk Conservatorium Brussel
Regentschapsstraat 30
1000 Brussel
Country [2] 290666 0
Belgium
Secondary sponsor category [3] 290667 0
University
Name [3] 290667 0
University of Antwerp
Address [3] 290667 0
Universiteit Antwerpen
Campus Groenenborger
Groenenborgerlaan 171
G.U.342
2020 Antwerpen
Country [3] 290667 0
Belgium
Other collaborator category [1] 278617 0
Individual
Name [1] 278617 0
Johan Loeckx
Address [1] 278617 0
Vrije Universiteit Brussel - Free University of Brussels
WE - DINF - ARTI
Pleinlaan 2
1050 Brussels
Belgium
Country [1] 278617 0
Belgium

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293490 0
Etisch commitee UZBrussel - VUB
Ethics committee address [1] 293490 0
Ethics committee country [1] 293490 0
Belgium
Date submitted for ethics approval [1] 293490 0
08/09/2014
Approval date [1] 293490 0
29/10/2014
Ethics approval number [1] 293490 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60118 0
Mr Koen Dries
Address 60118 0
Koen Dries
Vrije Universiteit Brussel
Kuilstraat 3
2480 Dessel
Country 60118 0
Belgium
Phone 60118 0
+32 479 21 23 42
Fax 60118 0
Email 60118 0
[email protected]
Contact person for public queries
Name 60119 0
Koen Dries
Address 60119 0
Koen Dries
Vrije Universiteit Brussel
Kuilstraat 3
2480 Dessel
Country 60119 0
Belgium
Phone 60119 0
+32 479 21 23 42
Fax 60119 0
Email 60119 0
[email protected]
Contact person for scientific queries
Name 60120 0
Koen Dries
Address 60120 0
Koen Dries
Vrije Universiteit Brussel
Kuilstraat 3
2480 Dessel
Country 60120 0
Belgium
Phone 60120 0
+32 479 21 23 42
Fax 60120 0
Email 60120 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.