UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041486 |
|---|---|
| Receipt number | R000047362 |
| Scientific Title | Relationships between dietary habits, exercise and locomotive syndrome in workers |
| Date of disclosure of the study information | 2020/08/26 |
| Last modified on | 2022/06/16 09:56:39 |
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Basic information
Public title
Relationships between dietary habits, exercise and locomotive syndrome in workers
Acronym
Cluster randomized controlled trial
Scientific Title
Relationships between dietary habits, exercise and locomotive syndrome in workers
Scientific Title:Acronym
Cluster randomized controlled trial
Region
| Japan |
Condition
Condition
Locomotive syndrome
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In a cluster randomized controlled trial, locomotion training alone and simultaneous intervention with locomotive training and dietary guidance will be conducted, and the effect of the intervention will be verified by comparing body composition and locomotive syndrome incidence among companies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Locomotive test (locomo25, two-step test, standing test) and body composition measurement of one year after the start of intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
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
The intervention group performs locomotion training before working hours
Interventions/Control_2
The intervention group provides meal instruction once a 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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Day shift employees working at each company
Key exclusion criteria
The participants are not eligible to participate in the survey if they: (a) can not walk without instruments (T-cane, crutch, wheelchair etc...); (b) have some sort of injury so as to hinder exercise at the time of the survey.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Ohtsuki |
Organization
Suzuka University of Medical Science
Division name
Department of Clinical Nutrition
Zip code
5100293
Address
Kishioka-cho, Suzuka, Mie 510-0293, Japan
TEL
0593838991
ohtsukim@suzuka-u.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ohtsuki |
Organization
Suzuka University of Medical Science
Division name
Department of Clinical Nutrition
Zip code
5100293
Address
Kishioka-cho, Suzuka, Mie 510-0293, Japan
TEL
0593838991
Homepage URL
ohtsukim@suzuka-u.ac.jp
Sponsor or person
Institute
Suzuka University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Suzuka University of Medical Science
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
Suzuka University of Medical Science
Address
Kishioka-cho, Suzuka, Mie 510-0293, Japan.
Tel
0593838991
ohtsukim@suzuka-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
| 2020 | Year | 08 | Month | 26 | 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
| 2020 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 20 | Day |
Last modified on
| 2022 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047362
