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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038864
Receipt No. 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

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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
Email 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
Email shimo@reha.kobegakuin.ac.jp

Sponsor
Institute Aichi Medical University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044321

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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