UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061793 |
|---|---|
| Receipt number | R000070619 |
| Scientific Title | Risk Factors for Playing-Related Disorders and Evaluation of Health Maintenance Interventions among High School Wind Orchestra Members: A Longitudinal Analysis Incorporating Psychosocial Factors |
| Date of disclosure of the study information | 2026/06/04 |
| Last modified on | 2026/06/03 23:18:52 |
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Basic information
Public title
Risk Factors for Playing-Related Disorders and Evaluation of Health Maintenance Interventions among High School Wind Orchestra Members: A Longitudinal Analysis Incorporating Psychosocial Factors
Acronym
Risk Factors for Playing-Related Disorders and Evaluation of Health Maintenance Interventions among High School Wind Orchestra Members: A Longitudinal Analysis Incorporating Psychosocial Factors
Scientific Title
Risk Factors for Playing-Related Disorders and Evaluation of Health Maintenance Interventions among High School Wind Orchestra Members: A Longitudinal Analysis Incorporating Psychosocial Factors
Scientific Title:Acronym
Risk Factors for Playing-Related Disorders and Evaluation of Health Maintenance Interventions among High School Wind Orchestra Members: A Longitudinal Analysis Incorporating Psychosocial Factors
Region
| Japan |
Condition
Condition
Playing-Related Disorders
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the presence and severity of physical (musculoskeletal) and mental symptoms among instrumental musicians from high school to university, utilizing both self-administered questionnaires and objective evaluations conducted by physical and occupational therapists. Additionally, this study statistically examines the relationship between these symptoms and factors such as years of playing experience and instrument type. Furthermore, the effectiveness of preliminary interventions, including warm-up exercises, will be evaluated. Through these investigations, we aim to provide evidence that contributes to the design of future preventive interventions and educational programs.
Basic objectives2
Others
Basic objectives -Others
Prevention
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gunma University Instrumental Musician Physical Disturbance Questionnaire, G-IMPDQ
Key secondary outcomes
Clinical Perfectionism Questionnaire
Physical function assessment
The New Physical Fitness Test
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
A standardized 20-minute conditioning program (warm-up and self-care routines) performed before playing, recommended at least 3 times a week. The program consists of: (1) dynamic warm-up (marching in place, shoulder circles), (2) neck and shoulder stretches, (3) forearm and wrist stretches, (4) lower limb and hip stretches, (5) balance exercises (single-leg standing), and (6) core exercises (bird-dog, planks). Initial instruction is provided face-to-face by physical or occupational therapists, followed by self-directed sessions at each school using instructional videos and materials.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Being enrolled in a high school within Gunma Prefecture.
Belonging to a wind orchestra club and continuously engaging in musical instrument performance.
Obtaining written informed consent for study participation from both the participant and their parent or guardian.
Being in a health condition that permits the implementation of surveys and physical measurements.
Key exclusion criteria
Individuals diagnosed by a physician as requiring rest, making physical evaluation or light exercise difficult.
Individuals whose willingness to participate is unclear and whose parents or guardians do not provide consent.
Individuals with cognitive or linguistic limitations that prevent them from answering the questionnaire (determined in consultation with club advisors).
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Tanaka |
Organization
Gunma University
Division name
Graduate School of Health Sciences
Zip code
371-8514
Address
3-39-22 Showa-machi, Maebashi, Gunma,Japan
TEL
027-220-8955
kojit929@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Tanaka |
Organization
Gunma University
Division name
Graduate School of Health Sciences
Zip code
371-8514
Address
3-39-22 Showa-machi, Maebashi, Gunma,Japan
TEL
027-220-8955
Homepage URL
kojit929@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Institutional Review Board for Life Science and Medical Research
Address
3-39-15 Showa-machi, Maebashi, Gunma,Japan
Tel
027-220-8740
hitotaisho-ciru@ml.gunma-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 04 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 03 | Day |
Last modified on
| 2026 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070619
