UMIN-CTR Clinical Trial

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
Email	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
Email	ohtsukim@suzuka-u.ac.jp

Sponsor
Institute	Suzuka University of Medical Science
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047362