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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025576
Receipt No. R000029433
Scientific Title Prevalence of sarcopenia in orthopedic upper extremity disease
Date of disclosure of the study information 2017/01/10
Last modified on 2017/01/08

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Basic information
Public title Prevalence of sarcopenia in orthopedic upper extremity disease
Acronym Prevalence of sarcopenia in orthopedic upper extremity disease
Scientific Title Prevalence of sarcopenia in orthopedic upper extremity disease
Scientific Title:Acronym Prevalence of sarcopenia in orthopedic upper extremity disease
Region
Japan

Condition
Condition Orthopedic upper limb disorders and Osteoporosis
Classification by specialty
Orthopedics Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We study the prevalence of sarcopenia in patients with orthopedic upper extremity disease and Osteoporosis.
Basic objectives2 Others
Basic objectives -Others Based on Objective1,collect information for prevemtive rehabilitation intervention for this patient group.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Three items of muscle mass(DXA method),muscular strength(grip strength)and walking speed necessary for diagnosis of sarcopenia are measured only for the first time.
Key secondary outcomes As a secondary indicator,we perform body composition analyzer(Inbody),swallowing function evaluation etc only for the first time within the range of usual medical treatment.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
50 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Both males and fnmales are over 50 years old, and gender is not specified.
Key exclusion criteria Psychiatric disorders,dementia,postoperative patients,pacemakers are excluded.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Fujita
Organization Tokyo Medical and Dental University Medical School Hospital
Division name Orthopedics Assistant professor
Zip code
Address 1-5-45 Yushima,Bunkyo-ku,Tokyo
TEL 03-5803-5279
Email fujiorth@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Fujita
Organization Tokyo Medical and Dental University Medical School Hospital
Division name Orthopedics Assistant professor
Zip code
Address 1-5-45 Yushima,Bunkyo-ku,Tokyo
TEL 03-5803-5279
Homepage URL http://tmdu-orth.jp/
Email fujiorth@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University Medical School Hospital Orthopedics
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 M2015-567
Org. issuing International ID_1 Tokyo Medical and Dental University Medical School Ethics Review Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京医科歯科大学医学部附属病院
Tokyo Medical and Dental University Medical School Hospital

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 10 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 Enrolling by invitation
Date of protocol fixation
2016 Year 04 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2017 Year 01 Month 08 Day
Last modified on
2017 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029433

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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