UMIN-ICDS Clinical Trial

Public title

Relationship between locomotive syndrome and lifestyle-related diseases in people undergoing medical checkups

Acronym

Relationship between locomotive syndrome and lifestyle-related diseases in people undergoing medical checkups

Scientific Title

Relationship between locomotive syndrome and lifestyle-related diseases in people undergoing medical checkups

Scientific Title:Acronym

Relationship between locomotive syndrome and lifestyle-related diseases in people undergoing medical checkups

Region

Japan

Condition

locomotive syndrome, lifestyle-related diseases

Classification by specialty

Geriatrics	Orthopedics	Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

In this study, as basic research toward the construction of a lifestyle guidance program aimed at extending healthy life expectancy, we analyzed the relationship between locomotive syndrome and metabolic syndrome based on cross-sectional and longitudinal surveys on locomotive syndrome and lifestyle-related diseases, and analyzed the relationship between locomotive syndrome and metabolic syndrome. The purpose is to clarify the causal relationship between disabilities.

Furthermore, based on these research results, we will develop a lifestyle guidance program for middle-aged and elderly people, and by verifying the effectiveness of that program, we aim to construct a comprehensive lifestyle guidance program that will lead to longer healthy life expectancies.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Occurrence of locomotive syndrome and lifestyle-related diseases

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

90

years-old

>=

Gender

Male and Female

Key inclusion criteria

Complete medical checkup recipient

Key exclusion criteria

Long-term care insurance users and persons certified as physically disabled

Target sample size

40000

Name of lead principal investigator

1st name	Tomoyuki
Middle name
Last name	Arai

Organization

Saitama Medical University

Division name

Department of Physical Therapy Faculty of Health and Medical Care

Zip code

350-0496

Address

981, Kawakado, Irumagun, Saitama 350-0436, Japan

TEL

0492951001

Email

arai_tm@saitama-med.ac.jp

Name of contact person

1st name	Tomoyuki
Middle name
Last name	Arai

Organization

Saitama Medical University

Division name

Department of Physical Therapy Faculty of Health and Medical Care

Zip code

350-0496

Address

981, Kawakado, Irumagun, Saitama 350-0436, Japan

TEL

049-295-1001

Homepage URL

Email

arai_tm@saitama-med.ac.jp

Institute

Saitama Medical University

Institute

Department

Personal name

Organization

JSPS KAKENHI

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethical Committee of Saitama Medical University

Address

38 Morohongo, Moroyama-cho, Iruma-gun, Saitama

Tel

049-276-2143

Email

rinri@saitama-med.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

12

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2020

Year

01

Month

15

Day

Date of IRB

2020

Year

01

Month

15

Day

Anticipated trial start date

2020

Year

01

Month

15

Day

Last follow-up date

2026

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Cross-sectional analysis will be conducted every year targeting those who took the Locomotive Motion Level Test from 2016 to March 2026.
Analyze the relationship between locomotive syndrome level and the results of each locomotive level test, lifestyle questionnaire, physical measurements, blood pressure, liver function, glucose tolerance, lipids, and bone density.

Longitudinal analysis will be conducted using data from people who continuously underwent medical checkups over a four-year period from 2016 to March 2020.
Analyze changes over time in the degree of locomotive behavior over a 4-year period.
Clarify the factors related to improvement and deterioration of locomotive syndrome from lifestyle questionnaire, physical measurements, blood pressure, liver function, glucose tolerance, lipids, and bone density.
Clarify whether improvement or worsening of locomotive syndrome affects lifestyle-related diseases.

Registered date

2023

Year

12

Month

15

Day

Last modified on

2023

Year

12

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060617