UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028121 |
|---|---|
| Receipt number | R000031954 |
| Scientific Title | Study on influence of locomotive syndrome on health |
| Date of disclosure of the study information | 2017/07/07 |
| Last modified on | 2020/07/09 09:54:14 |
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Basic information
Public title
Study on influence of locomotive syndrome on health
Acronym
Study on influence of locomotive syndrome on health
Scientific Title
Study on influence of locomotive syndrome on health
Scientific Title:Acronym
Study on influence of locomotive syndrome on health
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Locomotive syndrome (hereinafter referred to as LOCOMO) is considered to be in a state of high risk of requiring nursing care as the motor function decrease due to the disorder of locomotive organ.
In this research, the aim is to clarify factors causing motor function deterioration, to clarify the relationship between degree of motor function decline and nursing care risk, and to obtain basic data that contributes to effective LOCOMO countermeasures.
Basic objectives2
Others
Basic objectives -Others
this research will be executed as the academic study activities as the aim gaining new knowledge in the LOCOMO field.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Construct evidence of intervention effect on LOCOMO
Key secondary outcomes
Collection of basic data in LOCOMO research
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
At the same time doing physical fitness measurement and locomotion test on volunteers aged 20 years or older who got research consent, instruct LOCOMO training (hereinafter referred to LOCOTORE) and let them continue LOCOTORE as long as possible for 3 to 12 months, measure the same items after 3, 6, 9 and 12 months and verify the effect of LOCOTORE.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subject
Volunteers who wish to participate in LOCOMO enlightenment activities tackled by facilities participating in this research
Selection Criteria
1.Volunteers are 20 years of age or older at the time of consent acquisition
2.Volunteers who were confirmed about exerciser disease and other past medical history and had no obstacle to motor function
3.Volunteers who obtain documents consent by free will after sufficient understandings as receiving the sufficient explanation upon participation in this research,
Key exclusion criteria
1.Volunteers who are not be able to obtain consent from the principal about using data in this research
2.Volunteers who are not able to walk independently
3.Volunteers who are not able to fill out questionnaire by themselves
4.Volunteers who are not able to fully understand the instruction and
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Etsuo |
| Middle name | |
| Last name | Chosa |
Organization
University of Miyazaki Hospital
Division name
Department of Orhtopaedics, Faculty of Medicine
Zip code
889-1692
Address
5200 Kihara, Kiyotake, Miyazaki 889-1692, JAPAN
TEL
0985-85-0986
seikei@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Etsuo |
| Middle name | |
| Last name | Chosa |
Organization
University of Miyazaki Hospital
Division name
Department of Orhtopaedics, Faculty of Medicine
Zip code
889-1692
Address
5200 Kihara, Kiyotake, Miyazaki 889-1692, JAPAN
TEL
0985-85-0986
Homepage URL
seikei@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki Hospital
Department of Orhtopaedics, Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
University of Miyazaki Hospital
Department of Orhtopaedics, Faculty of Medicine
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
Miyazaki University
Address
5200 Kihara Kiyotake Miyazaki
Tel
0985-85-0986
seikei@med.miyazaki-u.ac.jp
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 | 07 | Month | 07 | Day |
Related information
URL releasing protocol
no publication
Publication of results
Unpublished
Result
URL related to results and publications
no publicaton
Number of participants that the trial has enrolled
0
Results
No result.
Results date posted
| 2020 | Year | 04 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
no results.
Participant flow
no results.
Adverse events
no results.
Outcome measures
no results.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2019 | 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
| 2017 | Year | 07 | Month | 07 | Day |
Last modified on
| 2020 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031954
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
