UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032535 |
|---|---|
| Receipt number | R000037105 |
| Scientific Title | Effect of Personal Exercise Instruction at Workplace for Worker; a Single Blinded Randomized Controlled Trial |
| Date of disclosure of the study information | 2018/05/09 |
| Last modified on | 2019/06/07 08:48:13 |
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Basic information
Public title
Effect of Personal Exercise Instruction at Workplace for Worker; a Single Blinded Randomized Controlled Trial
Acronym
Randomized Controlled Trial of Personal Exercise Instruction for Worker
Scientific Title
Effect of Personal Exercise Instruction at Workplace for Worker; a Single Blinded Randomized Controlled Trial
Scientific Title:Acronym
Randomized Controlled Trial of Personal Exercise Instruction for Worker
Region
| Japan |
Condition
Condition
Healthy workers
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of personal exercise instruction at workplace for worker.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
30-second chair stand test
Key secondary outcomes
Grip strength, WHO-Health and work Performance Questionnaire, Work Ability Index, Work functioning Impairment Scale, Body composition, Roland-Morris Disability Questionnaire, Center for Epidemiologic Studies Depression Scale, Exercise self-efficacy scale, Behavior change stage related to physical activity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
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
Personal exercise instruction group: Personal exercise instruction including interview and examination is conducted by physical therapist for 1 session/month for 6 month.
Interventions/Control_2
Group exercise instruction group: Group exercise instruction is conducted by physical therapist for 1 session in 6 month.
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Worker who are aged 20-64 years old
Key exclusion criteria
Participants with severe cardiovascular disease
Participants with severe respiratory disease
Participants with severe musculoskeletal disease
Participants with neurological disease
Participants who wish to resign within 1 year from the research start date
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoru Saeki |
Organization
University of Occupational and Environmental Health, Japan
Division name
Rehabilitation Medicine
Zip code
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu 807-8555, Japan
TEL
093-691-7266
sae@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryutaro Matsugaki |
Organization
Graduate school of University of Occupational and Environmental Health, Japan
Division name
Rehabilitation Medicine
Zip code
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu 807-8555, Japan
TEL
093-603-6691
Homepage URL
pt-matsugaki@clnc.uoeh-u.ac.jp
Sponsor or person
Institute
Department of Rehabilitation Medicine, University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 05 | Month | 09 | 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
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 26 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 09 | Day |
Last modified on
| 2019 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037105
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
