UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025576
Receipt number 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 13:14:12

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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 or person

Institute

Tokyo Medical and Dental University Medical School Hospital Orthopedics

Institute

Department

Personal name



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

Value
https://center6.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