UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005967 |
|---|---|
| Receipt number | R000007055 |
| Scientific Title | Research on assessment methods of musculoskeletal diseases and effective intervention programs for the prevention of the elderly requiring long-term care due to the locomotive syndrome. |
| Date of disclosure of the study information | 2011/07/12 |
| Last modified on | 2014/04/24 15:44:55 |
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Basic information
Public title
Research on assessment methods of musculoskeletal diseases and effective intervention programs for the prevention of the elderly requiring long-term care due to the locomotive syndrome.
Acronym
Research on assessment methods of musculoskeletal diseases and effective intervention programs.
Scientific Title
Research on assessment methods of musculoskeletal diseases and effective intervention programs for the prevention of the elderly requiring long-term care due to the locomotive syndrome.
Scientific Title:Acronym
Research on assessment methods of musculoskeletal diseases and effective intervention programs.
Region
| Japan |
Condition
Condition
locomotive syndrome
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of objective assessment methods of musculoskeletal diseases and effective intervention programs to prevent deterioration of activities of daily living due to musculoskeletal disorders
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
bone mineral density, bone strength, cartilage thickness, muscle volume, muscle strength, physical performance, activities of daily living
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
exercise for 3 months
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
person who did not attend the exercise program by the local self-governing body and agree with attending this exercise program
Key exclusion criteria
person who attended the exercise program by the local self-governing body
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Akune |
Organization
University of Tokyo
Division name
University of Tokyo Hospital
Zip code
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo
TEL
03-5800-9178
akune-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Akune |
Organization
University of Tokyo
Division name
University of Tokyo Hospital
Zip code
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo
TEL
03-5800-9178
Homepage URL
akune-tky@umin.ac.jp
Sponsor or person
Institute
University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
University of Miyazaki
Name of secondary funder(s)
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
| 2011 | Year | 07 | Month | 12 | 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
| 2011 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | 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
| 2011 | Year | 07 | Month | 12 | Day |
Last modified on
| 2014 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007055
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
