UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023744
Receipt number R000027351
Scientific Title Correlation research of sarcopenia, skeletal muscle and disease activity in rheumatoid arthritis (CHIKARA) study
Date of disclosure of the study information 2016/08/25
Last modified on 2019/08/27 11:01:51

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Basic information

Public title

Correlation research of sarcopenia, skeletal muscle and disease activity in rheumatoid arthritis (CHIKARA) study

Acronym

CHIKARA study

Scientific Title

Correlation research of sarcopenia, skeletal muscle and disease activity in rheumatoid arthritis (CHIKARA) study

Scientific Title:Acronym

CHIKARA study

Region

Japan


Condition

Condition

rheumatoid arthritis

Classification by specialty

Clinical immunology Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We investigate the correlation of sarcopenia, locomotive syndrome, and disease activity in patients with rheumatoid arthritis by using bioelectrical impedance analysis.

Basic objectives2

Others

Basic objectives -Others

We investigate the correlation of sarcopenia, locomotive syndrome, and fall, fracture.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

skeletal mass index after one year

Key secondary outcomes

bone mass, fat mass, basal metabolic rate, disease activity score 28, simplified disease activity index, health assessment questionnaire, rate of fall and fracture


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) patients with rheumatiod arthritis diagnosed by ACR/EULAR 2010 classification
2) patient who are recieving standard RA treatment
3) disease duration is no object.

Key exclusion criteria

1) patients who had severe complication
2) patients who had cannot keep standing

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Masahiro
Middle name
Last name Tada

Organization

Osaka City General Hospital

Division name

orthpaedic surgery

Zip code

534-0021

Address

2-13-22, Miyakojima-hondori, Miyakojima-ku, Osaka

TEL

06-6929-1221

Email

m-tada@med.osaka-cu.ac.jp


Public contact

Name of contact person

1st name Masahiro
Middle name
Last name Tada

Organization

Osaka City General Hospital

Division name

orthpaedic surgery

Zip code

534-0021

Address

2-13-22, Miyakojima-hondori, Miyakojima-ku, Osaka

TEL

06-6929-1221

Homepage URL


Email

m-tada@med.osaka-cu.ac.jp


Sponsor or person

Institute

Department of orthpaedic surgery, Osaka City General Hospital

Institute

Department

Personal name



Funding Source

Organization

Department of orthpaedic surgery, Osaka City General Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Osaka City General Hospital Research Ethics Review Board

Address

2-13-22, Miyakojima-hondori, Miyakojima-ku, Osaka

Tel

06-6929-1221

Email

xc0017@osakacity-hp.or.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

2016 Year 08 Month 25 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

100

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

Completed

Date of protocol fixation

2016 Year 08 Month 24 Day

Date of IRB

2015 Year 07 Month 07 Day

Anticipated trial start date

2016 Year 08 Month 25 Day

Last follow-up date

2018 Year 08 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We measure the skeletal mass index and basal metabolic rate of patients with rheumatoid arthritis by equipment of bioelectrical impedance analysis.


Management information

Registered date

2016 Year 08 Month 24 Day

Last modified on

2019 Year 08 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027351


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name