UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018250 |
|---|---|
| Receipt number | 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 | 2021/01/12 16:35:08 |
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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
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
nt229356@tsc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021121
| Research Plan | |
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| Registered date | File name |
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