UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059817 |
|---|---|
| Receipt number | R000068401 |
| Scientific Title | Effects of Fall-Prevention Education on Workers: A Randomized Controlled Trial Conducted at a Workplace in a prefecture |
| Date of disclosure of the study information | 2025/12/02 |
| Last modified on | 2025/11/18 21:26:22 |
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Basic information
Public title
Effects of Fall-Prevention Education on Workers: A Randomized Controlled Trial Conducted at a Workplace in a prefecture
Acronym
Effects of Fall-Prevention Education on Workers
Scientific Title
Effects of Fall-Prevention Education on Workers: A Randomized Controlled Trial Conducted at a Workplace in a prefecture
Scientific Title:Acronym
Effects of Fall-Prevention Education on Workers
Region
| Japan |
Condition
Condition
Healthy workers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of health education aimed at fall prevention by comparing changes in physical function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in physical function measurement values (2-step test, seated stepping test, functional reach test, closed-eye single-leg stand test, open-eye single-leg stand) before and after intervention
Key secondary outcomes
Falls in the past 3 months, low back pain, shoulder stiffness, and presenteeism
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Health education for fall prevention
Interventions/Control_2
Distribution of educational materials for fall prevention
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Individuals who are 18 years of age or older at the time of providing informed consent for participation
(2) Individuals who are currently employed at a workplace in Nagano Prefecture at the time of enrollment and whose employment at the same workplace is anticipated to continue through March 2026
(3) Individuals who have received comprehensive information regarding study participation and have provided voluntary written informed consent
Key exclusion criteria
(1) Pregnant individuals
(2) Individuals whose working hours or working days constitute less than three-quarters of standard full-time employment
(3) Individuals deemed unsuitable as research participants by the principal investigator
Target sample size
222
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Hasegawa |
Organization
Shinshu University School of Medicine
Division name
Department of Preventive Medicine and Public Health
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2622
koheih@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Hasegawa |
Organization
Shinshu University School of Medicine
Division name
Department of Preventive Medicine and Public Health
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2622
Homepage URL
koheih@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu 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
Shinshu University School of Medicine Biological and Medical Research Ethics Committee
Address
3-1-1 Asahi, Matsumoto, Nagano
Tel
0263-37-2572
mdrinri@shinshu-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
| 2025 | Year | 12 | Month | 02 | 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 | 06 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 02 | 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 | 11 | Month | 18 | Day |
Last modified on
| 2025 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068401
