UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049735 |
|---|---|
| Receipt number | R000054231 |
| Scientific Title | Analyses of outcomes with Belt electrode Skeletal muscle Electrical Stimulation and rehabilitation treatment for patients with rheumatoid arthritis |
| Date of disclosure of the study information | 2022/12/10 |
| Last modified on | 2023/12/10 10:19:30 |
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Basic information
Public title
Analyses of outcomes with Belt electrode Skeletal muscle Electrical Stimulation and rehabilitation treatment for patients with rheumatoid arthritis
Acronym
Combination of B-SES and rehabilitation for RA
Scientific Title
Analyses of outcomes with Belt electrode Skeletal muscle Electrical Stimulation and rehabilitation treatment for patients with rheumatoid arthritis
Scientific Title:Acronym
Combination of B-SES and rehabilitation for RA
Region
| Japan |
Condition
Condition
rhuematoid arthritis
Classification by specialty
| Clinical immunology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively compare the impact of conventional rehabilitation therapy and rehabilitation therapy using B-SES as part of exercise therapy on skeletal muscle mass in RA patients, grouped by whether or not B-SES is administered, based on existing information.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
body composition
Key secondary outcomes
function: grip power, gait speed, muscle strength ADL, QOL, physical activity
every 3 months
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
RA patients
Disease activity is determined as remission or low disease activity by the simplified disease activity index.
Patients who will be treated with outpatient rehabilitation once or twice a week for a total of 3 months
Women who are pregnant or not of childbearing potential
No implanted cardiac pacemaker
Key exclusion criteria
Medication: Induction of a biologic or JAK inhibitor during the observation period, increase of prednisolone dose by more than 5 mg, and
Steroid joint injections into load-bearing joints are required and administered by the attending physician.
Patients who are in the hyperacute phase within 6 months of RA onset
Patients who have missed more than 50% of the weekly exercise therapy program.
Those deemed inappropriate by the attending physician.
Translated with www.DeepL.com/Translator (free version)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shogo |
| Middle name | |
| Last name | Toyama |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Orthopaedics
Zip code
6028566
Address
Kajii-cho 465, kamigyo-ju, Kyoto city
TEL
0752515549
shogot@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Norikazu |
| Middle name | |
| Last name | Hishikawa |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
6028566
Address
Kajii-cho 465, kamigyo-ju, Kyoto city
TEL
0752515324
Homepage URL
hisikawa@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
honjo orthopedic clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutinal Review Borad
Address
Kajii-cho 465, kamigyo-ju, Kyoto city
Tel
0752515337
rinri@koto.kpu-m.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
ほんじょう整形外科クリニック
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing paticular
Management information
Registered date
| 2022 | Year | 12 | Month | 08 | Day |
Last modified on
| 2023 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054231
| 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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