UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038864 |
|---|---|
| Receipt number | R000044321 |
| Scientific Title | Study of health and lifestyle of office workers |
| Date of disclosure of the study information | 2019/12/12 |
| Last modified on | 2020/06/17 13:11:34 |
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Basic information
Public title
Effect of a 12-week workplace interview intervention on physical activity and low back pain
Acronym
Effect of a 12-week workplace interview intervention on physical activity and low back pain
Scientific Title
Study of health and lifestyle of office workers
Scientific Title:Acronym
Study of health and lifestyle of office workers
Region
| Japan |
Condition
Condition
low back pain
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to investigate the effects of workplace interview intervention on increasing PA and improving LBP among office workers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
LBP severity(100 mm visual analog scale)
Key secondary outcomes
the Roland-Morris Disability Questionnaire (RDQ)
The physical function(6-min walking distance, Seated forward bends)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Workplace PA program aimed to increase the amount of everyday PA with adequate pacing
15-minute face-to-face individual counseling sessions during working hours once a week for 12 weeks
Interventions/Control_2
Education
Monitoring of physical activity
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Eligible participants are full-time Japanese workers with LBP symptoms for at least 12 weeks.
Key exclusion criteria
Exclusion criteria include cardiac, systemic, or inflammatory disease.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Shimo |
Organization
Kobe Gakuin University
Division name
Faculty of Rehabilitation
Zip code
6512180
Address
518 Arise, Ikawadani-cho, Nishi-ku, Kobe, Hyogo
TEL
0789742461
shimo@reha.kobegakuin.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Shimo |
Organization
Kobe Gakuin University
Division name
Faculty of Rehabilitation
Zip code
6512180
Address
518 Arise, Ikawadani-cho, Nishi-ku, Kobe, Hyogo
TEL
0789742461
Homepage URL
shimo@reha.kobegakuin.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
the Japanese Society of Physical Therapy
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
Aichi Medical University
Address
1-1 Karimata, Yazako
Tel
0561623311
amu_ethics@aichi-med-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
| 2019 | Year | 12 | Month | 12 | 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
37
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
| 2013 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2013 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2014 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 05 | 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
| 2019 | Year | 12 | Month | 12 | Day |
Last modified on
| 2020 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044321
| 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 |
