UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051019 |
|---|---|
| Receipt number | R000058165 |
| Scientific Title | Prospective study of the impact of repetitive motor function measurement on presenteeism improvement in workers |
| Date of disclosure of the study information | 2023/05/10 |
| Last modified on | 2024/01/23 09:22:22 |
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Basic information
Public title
Examination of Factors Associated with Motor Function and Presenteeism in Factory Workers
Acronym
Examination of Factors Associated with Motor Function and Presenteeism in Factory Workers
Scientific Title
Prospective study of the impact of repetitive motor function measurement on presenteeism improvement in workers
Scientific Title:Acronym
Examination of Factors Associated with Motor Function and Presenteeism in Factory Workers
Region
| Japan |
Condition
Condition
Factory worker
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the motor function test and lifestyle status of workers in various occupations, and to provide scientifically based exercise instruction and lifestyle improvement advice to those at risk for back pain and falls. Six months after that, re-measurements are to be made to investigate the degree of improvement in presenteeism.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
presenteeism
Key secondary outcomes
Blood pressure, pulse rate, grip strength, body composition, standing forward bending, 2-step test, basic attributes (age, gender, length of service, job title), number of medications taken, exercise limitations, exercise habits, online usage status, presence of back pain, history of falls, subjective health perspective, drinking habits, smoking history, sleep status
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Advice on back pain prevention, muscle strengthening exercises, and lifestyle improvement based on the results of the initial motor function test and lifestyle survey.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Factory worker
Key exclusion criteria
Persons with difficulty in measuring motor function
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Masakazu |
| Middle name | |
| Last name | Imaoka |
Organization
Osaka Kawasaki Rehabilitation University
Division name
Department of Rehabilitation
Zip code
5970104
Address
Mizuma158 Kaizuka city, Osaka
TEL
0724466700
imaokamasakazu@gmail.com
Public contact
Name of contact person
| 1st name | Masakazu |
| Middle name | |
| Last name | Imaoka |
Organization
Osaka Kawasaki Rehabilitation University
Division name
Department of Rehabilitation
Zip code
5970104
Address
Mizuma158 Kaizuka city, Osaka
TEL
072-446-6700
Homepage URL
imaokamasakazu@gmail.com
Sponsor or person
Institute
Osaka Kawasaki Rehabilitation University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Osaka Kawasaki Rehabilitation University
Address
Mizuma158, Kaizuka city, Osaka
Tel
072-446-6700
imaokamasakazu@gmail.com
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
| 2023 | Year | 05 | Month | 10 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 05 | Month | 09 | Day |
Last modified on
| 2024 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058165
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
