NCT06175286

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 18, 2023

Completed
Last Updated

February 5, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

November 24, 2023

Last Update Submit

February 2, 2024

Conditions

Respiratory Function

Keywords

Inspiratory muscle traininglung capacitymusicians

Outcome Measures

Primary Outcomes (7)

  • 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).

    5 weeks

  • subjective physical effort

    subjective physical effort, assessed with the Borg scale (scale: 6-20; 6= "Very, very light"; 20= "Very, very hard")

    5 weeks

  • dyspnea

    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)

    sEMG od the scalene, sternocleidomastoid, diaphragm and abdominal muscle activity (units of measure: millivolts)

    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)

    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)

    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: %).

    5 weeks

Study Arms (2)

POWERBreath

EXPERIMENTAL

Subjects will train with the POWERBreath twice per day, for 30 continous breaths

Other: POWERBreath Plus Medium Resistance training device

Control

NO INTERVENTION

Subjects will carry on with their normal daily life

Interventions

POWERBreath Plus Medium Resistance training deviceOTHER

30 inspirations with the POWERBreath Plus Medium Resistance training device, twice per day for 5 weeks

POWERBreath

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or over
  • years of musical experience

You may not qualify if:

  • lung disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escola Superior de Saúde da Universidade de Aveiro

Aveiro, 3810, Portugal

Location

Related Publications (2)

  • 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.

    PMID: 20795334BACKGROUND

  • 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.

    PMID: 27181328RESULT

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Catarina Monteiro

    University of Aveiro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor

Study Record Dates

First Submitted

November 24, 2023

First Posted

December 18, 2023

Study Start

April 1, 2023

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

February 5, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Data will be shared upon fundamented request.

Locations

PT(1)