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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000025764
Receipt No. R000029640
Scientific Title Intervention study for the clarification of locomotive syndrome and effectiveness of locomotion training.
Date of disclosure of the study information 2017/01/20
Last modified on 2017/07/26

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Basic information
Public title Intervention study for the clarification of locomotive syndrome and effectiveness of locomotion training.
Acronym Intervention study for the clarification of locomotive syndrome and effectiveness of locomotion training.
Scientific Title Intervention study for the clarification of locomotive syndrome and effectiveness of locomotion training.
Scientific Title:Acronym Intervention study for the clarification of locomotive syndrome and effectiveness of locomotion training.
Region
Japan

Condition
Condition locomotive syndrome, sarcopenia
Classification by specialty
Orthopedics Rehabilitation medicine Not applicable
Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the epidemiology of locomotive syndrome and the effectiveness of exercise.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes muscle mass, bone density, joint range of motion, locomotive syndrome risk level
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 exercise
Interventions/Control_2 no exercise
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients in our hospital who agree with our study and above 16 year-old.
Key exclusion criteria people who don't agree with our study
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chosa Etsuo
Organization University of MIYAZAKI
Division name Department of Orhtopaedics, Faculty of Medicine
Zip code
Address 5200 Kihara, Kiyotake, Miyazaki 889-1692, JAPAN
TEL 0985-85-0986
Email chosa@med.miyazaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yu Fukao
Organization University of MIYAZAKI
Division name Department of Orhtopaedics, Faculty of Medicine
Zip code
Address 5200 Kihara, Kiyotake, Miyazaki 889-1692, JAPAN
TEL 0985-85-0986
Homepage URL
Email yu_fukao@med.miyazaki-u.ac.jp

Sponsor
Institute University of MIYAZAKI
Institute
Department

Funding Source
Organization University of MIYAZAKI
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
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
2017 Year 01 Month 20 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
Date of protocol fixation
2015 Year 12 Month 28 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 28 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
2017 Year 01 Month 20 Day
Last modified on
2017 Year 07 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029640

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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