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
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
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
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
