UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041034 |
|---|---|
| Receipt number | R000046865 |
| Scientific Title | The prospective cohort study of frailty in patients with rheumatoid arthritis to extend healthy life expectancy (Fairy Study) |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2020/07/09 09:58:31 |
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Basic information
Public title
The prospective cohort study of frailty
in patients with rheumatoid arthritis to extend healthy life expectancy
Acronym
Fairy study
Scientific Title
The prospective cohort study of frailty
in patients with rheumatoid arthritis to extend healthy life expectancy (Fairy Study)
Scientific Title:Acronym
The prospective cohort study of frailty
in patients with rheumatoid arthritis to extend healthy life expectancy (Fairy Study)
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology | Geriatrics | Orthopedics |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify characteristic of frailty in patients with rheumatoid arthritis, including incidence rate of sarcopenia, locomotive syndrome (reduced physical function due to impaired locomotor function), and age-related changes in physical function
Basic objectives2
Others
Basic objectives -Others
To clarify factors related to impairment of physical function (frailty, sarcopenia, loco motive syndrome)
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) The proportion of RA patients with frailty, sarcopenia, and locomotive syndrome
2) The characteristics of the physical functions and movement abilities in RA patients
3) Factors related to frailty, sarcopenia, and locomotive syndrome in RA patients
Key secondary outcomes
Factors related to changes in physical function and movement ability of RA patients over time
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients with a confirmed diagnosis of rheumatoid arthritis based on the American College of Rheumatology 1987 criteria for rheumatoid arthritis or the 2010 ACR/EULAR criteria, and who continue treatment and follow-up by a rheumatologist.
2) Written informed consent from the target person regarding participation in this study
3) Those who can answer and fill out the self-administered survey form by themselves
Key exclusion criteria
Patients who the doctor judges to participate in this study are inappropriate
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Toshihisa |
| Middle name | |
| Last name | Kojima |
Organization
Nagoya University Hospital
Division name
Department of Orthopedic Surgery/ Rheumatology
Zip code
466-8550
Address
65 Tsurumai Showa, Nagoya, Japan
TEL
+81527441908
toshik@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Masataka |
| Middle name | |
| Last name | Maeda |
Organization
Nagoya University Hospital
Division name
Department of Orthopedic Surgery/ Rheumatology
Zip code
466-8550
Address
65 Tsurumai Showa, Nagoya, Japan
TEL
+81527441908
Homepage URL
bikari10@yahoo.co.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Center for Geriatrics and Gerontology
Name of secondary funder(s)
National Center for Geriatrics and Gerontology
IRB Contact (For public release)
Organization
Nagoya University Ethics Committee
Address
65 Tsurumai Showa, Nagoya, Japan
Tel
052-744-2061
ethics@med.nagoya-u.ac.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
| 2020 | Year | 09 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Frailty is defined as Fried's criteira, sarcopenia is defined as Skeletal muscle Mass Index (SMI) of less than 7.0 kg/m2 for men and 5.7 kg/m2 for women.locomotive syndrome is defined as 25-question Geriatric Locomotive Function Scale (GLFS-25)16 point or more.
1) ANOVA is used to compare the pathological conditions and background factors between those with frailty, sarcopenia, and locomotive syndrome and those without.
2) Compare changes in flail, sarcopenia, locomotive syndrome, physical function, and performance over time using general linear mixed models or repeated measures ANOVA.
Management information
Registered date
| 2020 | Year | 07 | Month | 08 | Day |
Last modified on
| 2020 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046865
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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