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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032535
Receipt No. 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

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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
Email 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
Email pt-matsugaki@clnc.uoeh-u.ac.jp

Sponsor
Institute Department of Rehabilitation Medicine, University of Occupational and Environmental Health, Japan
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037105

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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