UMIN-CTR Clinical Trial

Basic information
Public title	Verification of healthy life expectancy stretching effect of the musculoskeletal function assessment of local residents (prospective study)
Acronym	Verification of healthy life expectancy stretching effect of the musculoskeletal function assessment of local residents (prospective study)
Scientific Title	Verification of healthy life expectancy stretching effect of the musculoskeletal function assessment of local residents (prospective study)
Scientific Title:Acronym	Verification of healthy life expectancy stretching effect of the musculoskeletal function assessment of local residents (prospective study)
Region	Japan

Condition
Condition	locomotive syndrome
Classification by specialty	Geriatrics Orthopedics Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Health diagnosis, as to evaluate the health state,it is obliged to implement in schools,workplaces,local governments,consultation rate remained flat. In recent years, focusing on musculoskeletal disorders is an essential care main factor, The Japanese Orthopaedic Association has proposed the Locomotive syndrome. Therefore, for the purpose of long-term care costs increase suppression by musculoskeletal disorders, daily life functions in health diagnostic evaluation (locomotive syndrome risk test), further add to muscle function test (the lower extremity muscle strength), to perform the discovery and preventive intervention of early locomotive syndrome the thing, to verify its effectiveness.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To assess the level of the participants of motor function by which is carried out by adding locomotive syndrome risk test as daily life functional assessment and the lower limb muscle strength measurement as muscle function test and to regular health checks. The prescription of exercise in accordance with the level of motor function, to verify the motor function improving effect.
Key secondary outcomes	To confirm the change of medical examination consultation rate by adding implementing the motor function evaluation to medical examination. We consider the relevance of the medical examination data and motor function data. To compare the medical and nursing care and medical examination cost of the whole and the motor function evaluation participants.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment Behavior,custom
Interventions/Control_1	Once a month, six-month exercise guidance. 6 months and measurement by the activity meter of month. Once a month, lower limb muscle strength measurement of 6 months. 6-month implementation guidance of daily life record of month.
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

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	More than 40 years old, Kanagawa Prefecture Oiso-machi townsman of national health insurance screening project participants
Key exclusion criteria	If it is painful to any of the body. There is a disease in cardiovascular such as hypertension and blood vessels, when the musculoskeletal function assessment can not be carried out.
Target sample size	1500

Research contact person
Name of lead principal investigator	1st name Middle name Last name TOSHIYA NOSAKA
Organization	Tokai University
Division name	Department of Physical Education School of Physical Education
Zip code
Address	4-1-1 Kitakaname, Hiratsuka-shi, Kanagawa 259-1292 Japan
TEL	0463-58-1211
Email	nt229356@tsc.u-tokai.ac.jp

Public contact
Name of contact person	1st name Middle name Last name TOSHIYA NOSAKA
Organization	Tokai University
Division name	Department of Physical Education School of Physical Education
Zip code
Address	4-1-1 Kitakaname, Hiratsuka-shi, Kanagawa 259-1292 Japan
TEL	0463-58-1211
Homepage URL
Email	nt229356@tsc.u-tokai.ac.jp

Sponsor
Institute	Tokai University
Institute
Department

Funding Source
Organization	Ministry of Economy, Trade and Industry.
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	ALCARE Co., Ltd.
Name of secondary funder(s)	ALCARE Co., Ltd.

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	2015 Year 07 Month 10 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	2015 Year 06 Month 24 Day
Date of IRB	2015 Year 07 Month 01 Day
Anticipated trial start date	2015 Year 07 Month 11 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2015 Year 07 Month 08 Day
Last modified on	2021 Year 01 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021121