UMIN-CTR Clinical Trial

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
Email	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
Email	bikari10@yahoo.co.jp

Sponsor
Institute	Nagoya University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046865