UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059425 |
|---|---|
| Receipt number | R000067965 |
| Scientific Title | Introduction of Self-Check and Verification of Prevention Support Model in Companies and Health Examination Facilities |
| Date of disclosure of the study information | 2025/10/16 |
| Last modified on | 2025/10/16 08:53:35 |
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Basic information
Public title
Introduction of Self-Check and Verification of Prevention Support Model in Companies and Health Examination Facilities
Acronym
Self-Check Implementation and Prevention Model Project
Scientific Title
Introduction of Self-Check and Verification of Prevention Support Model in Companies and Health Examination Facilities
Scientific Title:Acronym
Self-Check Implementation and Prevention Model Project
Region
| Japan |
Condition
Condition
Study 1 Employees working in participating companies
Study 2 Adults who receive pre-employment or periodic health examinations
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate changes in musculoskeletal self-check results (Koji Awareness: KA) and health issues such as low back and neck/shoulder pain among company employees before and after an intervention period.
Through feedback reports, online consultations, and group exercise programs led by physical therapists, the study seeks to promote the prevention of musculoskeletal disorders and occupational accidents, thereby supporting workplace health management.
Furthermore, by integrating KA with regular medical checkups at health examination facilities, the study aims to develop and verify a novel primary prevention and health support model that enables early detection of physical function decline and promotes health awareness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Study 1 (Company Employees):
Changes in Koji Awareness (KA) scores
Changes in subjective musculoskeletal symptoms (low back pain, shoulder stiffness; NRS)
Changes in work productivity (single-item version, University of Tokyo)
Changes in quality of life (SF-36)
Changes in near-miss and occupational accident occurrences
Study 2 (Health Examination Participants):
Associations between KA scores and health checkup data (blood pressure, glucose, lipid profiles, etc.)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
In Company A, participants will perform "Corrective Exercise Program" for 12 weeks, receiving instruction from a trainer once a week.
In addition, they will participate in a comprehensive approach that includes seminars on low back pain and online consultation sessions conducted by physical therapists.
Interventions/Control_2
In Company B, participants will perform "Corrective Exercise Program" only, also for 12 weeks, with weekly instruction provided by a trainer.
Interventions/Control_3
Control group
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
| 18 | years-old | < |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adults aged between 18 and 65 years
Key exclusion criteria
If medical clearance for exercise cannot be obtained
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Morito |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
202-0021
Address
STEP 22, 3-4-1 Higashifushimi, Nishitokyo, Tokyo
TEL
042-452-7156
mori_tsuyo88@aoni.waseda.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Morito |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
2020021
Address
STEP22, 3-4-1 Higashifushimi, Nishitokyo-shi, Tokyo
TEL
042-452-7156
Homepage URL
mori_tsuyo88@aoni.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Management Division, Research Promotion Department, Waseda University
Address
1-104 Totsukacho, Shinjuku-ku, Tokyo 169-8050, Japan
Tel
03-5272-4652
rps-management@list.waseda.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2025-405
Org. issuing International ID_1
Ethics Committee for Research Involving Human Subjects, Waseda University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 10 | Month | 16 | Day |
Last modified on
| 2025 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067965
