UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024621 |
|---|---|
| Receipt number | R000028327 |
| Scientific Title | Reserch for the efects of the exercise intervention for prevention of locomotive syndrome. |
| Date of disclosure of the study information | 2017/01/01 |
| Last modified on | 2019/07/12 10:24:57 |
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Basic information
Public title
Reserch for the efects of the exercise intervention for prevention of locomotive syndrome.
Acronym
Effects of the exercise intervention for prevention of locomotive syndrome.
Scientific Title
Reserch for the efects of the exercise intervention for prevention of locomotive syndrome.
Scientific Title:Acronym
Effects of the exercise intervention for prevention of locomotive syndrome.
Region
| Japan |
Condition
Condition
locomotive syndrome
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To claryfy the effects of exercise intervention for prevention of locomotive syndrome on middle age.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
6 months and 12 months after intervention
physical fitness, degree of locomotive syndrome, blood testing
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
6months
exercise intervention
once a week or once every two weeks
Interventions/Control_2
6months
providing information
once a week or once every two weeks
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
| 45 | years-old | <= |
Age-upper limit
| 64 | years-old | > |
Gender
Male and Female
Key inclusion criteria
haelthy middle aged person
Key exclusion criteria
limitation of physical activity
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiro Wakimoto |
Organization
Kawasaki Medical school hospital
Division name
Health Check -up center
Zip code
Address
577 Matsushima Kurasihiki Okayama
TEL
086-462-1111
wakimoto@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiro Wakimoto |
Organization
Kawasaki Medical School Hospital
Division name
Health Check -up center
Zip code
Address
577 Matsushima Kurasihiki Okayama
TEL
086-462-1111
Homepage URL
wakimoto@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2017 | Year | 01 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 29 | Day |
Last modified on
| 2019 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028327
