UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052318 |
|---|---|
| Receipt number | R000059716 |
| Scientific Title | Feasibility study of a frailty prevention program for patients with rheumatoid arthritis |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2025/04/01 22:49:34 |
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Basic information
Public title
Feasibility study of a frailty prevention program for patients with rheumatoid arthritis
Acronym
Feasibility study of a frailty prevention program for patients with rheumatoid arthritis
Scientific Title
Feasibility study of a frailty prevention program for patients with rheumatoid arthritis
Scientific Title:Acronym
Feasibility study of a frailty prevention program for patients with rheumatoid arthritis
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to examine the feasibility of implementing a frailty prevention program for outpatients with rheumatoid arthritis.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
persistence rate of exercise
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
The exercise program including resistance training and aerobic exercise will be provided for subjects for seven times in 12 weeks.
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) with a low disease activity
2) could answer the questionnaire by themselves
3) could come to hospital for exercise training
Key exclusion criteria
1) using a wheelchair
2) are deemed ineligible for enrollment by the responsible researcher or co-researcher
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Mikako |
| Middle name | |
| Last name | Yasuoka |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Frailty Research
Zip code
474-8511
Address
7-430 Morioka-cho, Obu, Aichi, 474-8511, Japan
TEL
0562-46-2311
myasuoka52@outlook.jp
Public contact
Name of contact person
| 1st name | Mikako |
| Middle name | |
| Last name | Yasuoka |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Frailty Research
Zip code
Department of Frailty Research
Address
7-430 Morioka-cho, Obu, Aichi, 474-8511, Japan
TEL
0562-46-2311
Homepage URL
myasuoka52@outlook.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research and Medical Division
Address
7-430 Morioka-cho Obu Aichi Japan
Tel
0562-46-2311
yaday@ncgg.go.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
| 2023 | Year | 10 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 05 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 20 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 27 | Day |
Last modified on
| 2025 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059716
