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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018250
Receipt No. R000021121
Scientific Title Verification of healthy life expectancy stretching effect of the musculoskeletal function assessment of local residents (prospective study)
Date of disclosure of the study information 2015/07/10
Last modified on 2017/05/30

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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 Open public recruiting
Date of protocol fixation
2015 Year 06 Month 24 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 07 Month 08 Day
Last modified on
2017 Year 05 Month 30 Day


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

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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