Healthy VolunteersNCT07904858
Soft Tissue Relaxation in Trumpet Players
A study testing Integrated soft tissue relaxation (IASTM + manual release) in people with Healthy Volunteers and Muscle Tension, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial summary
This single-group pretest-posttest study examined the immediate effects of a single session of integrated soft tissue relaxation, combining instrument-assisted soft tissue mobilization (IASTM) and manual release techniques, on pulmonary function, resting breathing pattern, trumpet-playing acoustic performance, and… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Muscle Tension
- What is being tested?
- Integrated soft tissue relaxation (IASTM + manual release)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Sep 2025to 17 Sep 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 20-50 years
- At least 5 years of trumpet-playing experience
- Current practice or performance within the past 6 months
- No acute respiratory disease or major chronic illness
- Willing to provide written informed consent
Who cannot join
- Recent respiratory tract infection (e.g., common cold, acute asthma exacerbation) or clearly abnormal pulmonary function
- History of cardiovascular, neuromuscular, or severe neck, shoulder, or thoracic disorders
- Allergy to massage oil or lubricants
- Unable or unwilling to complete the study procedures
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taipei University of Nursing and Health Sciences, Department of Exercise and Health Science
Taipei, Taiwan, 112303
About this study
Official title: Investigating the Effects of Soft Tissue Mobilization on Respiratory Muscle Function and Playing Performance in Trumpet Players
This single-group pretest-posttest study examined the immediate effects of a single session of integrated soft tissue relaxation, combining instrument-assisted soft tissue mobilization (IASTM) and manual release techniques, on pulmonary function, resting breathing pattern, trumpet-playing acoustic performance, and perceived exertion in experienced trumpet players.
Read the detailed description
Brass players experience sustained high respiratory and orofacial muscle load. Fifteen healthy adult trumpet players with at least 5 years of playing experience completed baseline assessments, received one 15-20 min session of integrated soft tissue relaxation targeting the perioral, cervicothoracic, intercostal, diaphragmatic, and abdominal regions (IASTM combined with manual release; intensity 3-6 on a 0-10 participant-rated pressure scale), and repeated the same assessments immediately afterwards. Outcomes were forced pulmonary function and resting breathing pattern (CHEST HI-801 spirometer), acoustic features of four standardized playing tasks (automated pYIN-based analysis), and rating of perceived exertion (Borg 6-20).
This study was approved by the Institutional Review Board of Fu Jen Catholic University (C113180) on July 14, 2025, and data collection took place on September 10-17, 2025. The study was registered retrospectively after completion. Maximal inspiratory and expiratory pressures were listed in the approved protocol but could not be measured because the measurement module was unavailable during the data collection period.
- Conditions
- Healthy Volunteers, Muscle Tension
- Being tested
- Integrated soft tissue relaxation (IASTM + manual release)
- Keywords
- Manual therapy, Instrument-assisted soft tissue mobilization, Breathing pattern, Pulmonary function, Musicians, Pitch stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated soft tissue relaxation (IASTM + manual release)Other
Delivered by one trained practitioner according to a written protocol. Pressure was applied during exhalation and eased during inhalation, with intensity titrated to a participant-reported pressure of 3-6 on a 0-10 scale.
| Study group | Role | What they receive |
|---|---|---|
| Integrated soft tissue relaxation | Experimental | A single 15-20 min session of IASTM combined with manual release applied in a top-to-bottom sequence to the perioral, cervicothoracic, shoulder girdle, intercostal, diaphragmatic, and abdominal regions. Receives: Other: Integrated soft tissue relaxation (IASTM + manual release) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Vital Capacity (FVC)
FVC in liters (L), measured with a CHEST HI-801 spirometer.
Measured: Baseline (immediately before) and immediately after the single intervention session (same day)
Resting Minute Ventilation
Minute ventilation during quiet breathing in liters per minute (L/min), measured with a CHEST HI-801 spirometer.
Measured: Baseline (immediately before) and immediately after the single intervention session (same day)
Forced Expiratory Volume in 1 Second (FEV1)
FEV1 in liters (L), measured with a CHEST HI-801 spirometer.
Measured: Baseline (immediately before) and immediately after the single intervention session (same day)
Peak Expiratory Flow (PEF)
PEF in liters per second (L/s), measured with a CHEST HI-801 spirometer.
Measured: Baseline (immediately before) and immediately after the single intervention session (same day)
Maximal Voluntary Ventilation (MVV)
MVV in liters per minute (L/min), measured with a CHEST HI-801 spirometer.
Measured: Baseline (immediately before) and immediately after the single intervention session (same day)
Resting Tidal Volume
Tidal volume during quiet breathing in liters (L), measured with a CHEST HI-801 spirometer.
Measured: Baseline (immediately before) and immediately after the single intervention session (same day)
Resting Respiratory Rate
Respiratory rate during quiet breathing in breaths per minute, measured with a CHEST HI-801 spirometer.
Measured: Baseline (immediately before) and immediately after the single intervention session (same day)
Ventilatory Reserve
Ventilatory reserve in percent (%), calculated by the CHEST HI-801 spirometer from resting minute ventilation relative to MVV.
Measured: Baseline (immediately before) and immediately after the single intervention session (same day)
Secondary outcomes (8)
Standard Deviation of Fundamental Frequency During Sustained Note
Standard deviation of the fundamental frequency in hertz (Hz) during a sustained G4 note, extracted with automated pYIN-based acoustic analysis.
Measured: Baseline (immediately before) and immediately after the single intervention session (same day)
Mean Fundamental Frequency During Sustained Note
Mean fundamental frequency in hertz (Hz) during a sustained G4 note, extracted with automated pYIN-based acoustic analysis.
Measured: Baseline (immediately before) and immediately after the single intervention session (same day)
Lowest Attainable Pitch
Lowest fundamental frequency in hertz (Hz) reached during a descending pitch-range task.
Measured: Baseline (immediately before) and immediately after the single intervention session (same day)
Maximal loudness
Peak sound level in decibels relative to full scale (dBFS) during a G major arpeggio played at maximal controllable loudness.
Measured: Baseline (immediately before) and immediately after the single intervention session (same day)
Highest Attainable Pitch (Hz)
Highest fundamental frequency in hertz (Hz) reached during an ascending pitch-range task.
Measured: Baseline (immediately before) and immediately after the single intervention session (same day)
Highest Attainable Pitch (MIDI Semitones)
Highest pitch reached during the ascending pitch-range task, converted to MIDI semitone units.
Measured: Baseline (immediately before) and immediately after the single intervention session (same day)
Rating of perceived exertion
Rating of perceived exertion on the Borg 6-20 scale (minimum 6, maximum 20; higher scores indicate greater perceived exertion, i.e., a worse outcome), rated immediately after a high-register melody task.
Measured: Baseline (immediately before) and immediately after the single intervention session (same day)
Sustained-note duration
Duration in seconds (s) of a sustained G4 note played as long as possible.
Measured: Baseline (immediately before) and immediately after the single intervention session (same day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start10 Sep 2025
- Primary completion17 Sep 2025
- Study completion17 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants completed baseline assessments, received one session of integrated soft tissue relaxation, and were reassessed immediately afterwards.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu, Hsiao-Kuan, National Taipei University of Nursing and Health Sciences
- Investigators
- Hsiao-Kuan Wu, PhD, Principal investigator, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904858
- Sponsor's protocol ID
- C113180
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because participants consented to the use of their data only for this study, as approved by the ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Soft Tissue Mobilization on Respiratory Muscle Function and Playing Performance in Trumpet Players
- ClinicalTrials.gov ID
- NCT07904858
- Acronym / sponsor ID
- C113180
- Conditions
- Healthy Volunteers, Muscle Tension
- Keywords
- Manual therapy, Instrument-assisted soft tissue mobilization, Breathing pattern, Pulmonary function, Musicians, Pitch stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 17 Sep 2025 (actual)
- Study completion
- 17 Sep 2025 (actual)
- First posted
- 29 Oct 2026 (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 single-group pretest-posttest study examined the immediate effects of a single session of integrated soft tissue relaxation, combining instrument-assisted soft tissue mobilization (IASTM) and manual release techniques, on pulmonary function, resting breathing pattern, trumpet-playing acoustic performance, and perceived exertion in experienced trumpet players.
Detailed description
Brass players experience sustained high respiratory and orofacial muscle load. Fifteen healthy adult trumpet players with at least 5 years of playing experience completed baseline assessments, received one 15-20 min session of integrated soft tissue relaxation targeting the perioral, cervicothoracic, intercostal, diaphragmatic, and abdominal regions (IASTM combined with manual release; intensity 3-6 on a 0-10 participant-rated pressure scale), and repeated the same assessments immediately afterwards. Outcomes were forced pulmonary function and resting breathing pattern (CHEST HI-801 spirometer), acoustic features of four standardized playing tasks (automated pYIN-based analysis), and rating of perceived exertion (Borg 6-20).
This study was approved by the Institutional Review Board of Fu Jen Catholic University (C113180) on July 14, 2025, and data collection took place on September 10-17, 2025. The study was registered retrospectively after completion. Maximal inspiratory and expiratory pressures were listed in the approved protocol but could not be measured because the measurement module was unavailable during the data collection period.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants completed baseline assessments, received one session of integrated soft tissue relaxation, and were reassessed immediately afterwards.
| Arm | Type | Receives |
|---|---|---|
| Integrated soft tissue relaxation | Experimental | Other: Integrated soft tissue relaxation (IASTM + manual release)A single 15-20 min session of IASTM combined with manual release applied in a top-to-bottom sequence to the perioral, cervicothoracic, shoulder girdle, intercostal, diaphragmatic, and abdominal regions. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults aged 20-50 years
- At least 5 years of trumpet-playing experience
- Current practice or performance within the past 6 months
- No acute respiratory disease or major chronic illness
- Willing to provide written informed consent
Key exclusion criteria (4 listed)
- Recent respiratory tract infection (e.g., common cold, acute asthma exacerbation) or clearly abnormal pulmonary function
- History of cardiovascular, neuromuscular, or severe neck, shoulder, or thoracic disorders
- Allergy to massage oil or lubricants
- Unable or unwilling to complete the study procedures
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 |
|---|---|---|
| Integrated soft tissue relaxation (IASTM + manual release)Delivered by one trained practitioner according to a written protocol. Pressure was applied during exhalation and eased during inhalation, with intensity titrated to a participant-reported pressure of 3-6 on a 0-10 scale. | Other | Integrated soft tissue relaxation |
Primary outcome
Forced Vital Capacity (FVC)
Time frame: Baseline (immediately before) and immediately after the single intervention session (same day)
FVC in liters (L), measured with a CHEST HI-801 spirometer.
Resting Minute Ventilation
Time frame: Baseline (immediately before) and immediately after the single intervention session (same day)
Minute ventilation during quiet breathing in liters per minute (L/min), measured with a CHEST HI-801 spirometer.
Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline (immediately before) and immediately after the single intervention session (same day)
FEV1 in liters (L), measured with a CHEST HI-801 spirometer.
Peak Expiratory Flow (PEF)
Time frame: Baseline (immediately before) and immediately after the single intervention session (same day)
PEF in liters per second (L/s), measured with a CHEST HI-801 spirometer.
Maximal Voluntary Ventilation (MVV)
Time frame: Baseline (immediately before) and immediately after the single intervention session (same day)
MVV in liters per minute (L/min), measured with a CHEST HI-801 spirometer.
Resting Tidal Volume
Time frame: Baseline (immediately before) and immediately after the single intervention session (same day)
Tidal volume during quiet breathing in liters (L), measured with a CHEST HI-801 spirometer.
Resting Respiratory Rate
Time frame: Baseline (immediately before) and immediately after the single intervention session (same day)
Respiratory rate during quiet breathing in breaths per minute, measured with a CHEST HI-801 spirometer.
Ventilatory Reserve
Time frame: Baseline (immediately before) and immediately after the single intervention session (same day)
Ventilatory reserve in percent (%), calculated by the CHEST HI-801 spirometer from resting minute ventilation relative to MVV.
8 secondary outcomes
Standard Deviation of Fundamental Frequency During Sustained Note
Time frame: Baseline (immediately before) and immediately after the single intervention session (same day)
Mean Fundamental Frequency During Sustained Note
Time frame: Baseline (immediately before) and immediately after the single intervention session (same day)
Lowest Attainable Pitch
Time frame: Baseline (immediately before) and immediately after the single intervention session (same day)
Maximal loudness
Time frame: Baseline (immediately before) and immediately after the single intervention session (same day)
Highest Attainable Pitch (Hz)
Time frame: Baseline (immediately before) and immediately after the single intervention session (same day)
Highest Attainable Pitch (MIDI Semitones)
Time frame: Baseline (immediately before) and immediately after the single intervention session (same day)
Rating of perceived exertion
Time frame: Baseline (immediately before) and immediately after the single intervention session (same day)
Sustained-note duration
Time frame: Baseline (immediately before) and immediately after the single intervention session (same day)
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 29 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because participants consented to the use of their data only for this study, as approved by the ethics committee.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
Hsiao-Kuan Wu, PhD principal investigator
National Taipei University of Nursing and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated soft tissue relaxation (IASTM + manual release) in people with Healthy Volunteers and Muscle Tension, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
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 5 inclusion and 4 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 29 Oct 2026. 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 Taiwan. 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?
Forced Vital Capacity (FVC) (time frame: Baseline (immediately before) and immediately after the single intervention session (same day)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2026.