UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050022 |
|---|---|
| Receipt number | R000056986 |
| Scientific Title | Verification of nutritional guidance and exercise therapy for patients with Rheumatoid Arthritis at Risk for Sarcopenia |
| Date of disclosure of the study information | 2023/01/12 |
| Last modified on | 2023/01/12 18:22:02 |
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Basic information
Public title
Long-term verification of nutritional guidance and exercise therapy for patients with Rheumatoid Arthritis at Risk for Sarcopenia
Acronym
Verification of nutritional guidance and exercise therapy for patients with Rheumatoid Arthritis at Risk for Sarcopenia
Scientific Title
Verification of nutritional guidance and exercise therapy for patients with Rheumatoid Arthritis at Risk for Sarcopenia
Scientific Title:Acronym
Verification of a combined intervention for patients with rheumatoid arthritis
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A single-center, nonrandomized, controlled study of the effect of long-term of nutritional guidance and exercise therapy for RA patients with sarcopenia or at risk for sarcopenia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in Skeletal muscle Index, body fat percentage after 12 months
Key secondary outcomes
Changes in grip strength, gait speed, MNA-SF, and nutrient and dietary intake after 12 months
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom | Maneuver |
Interventions/Control_1
Exercise therapy is conducted once a month and consists mainly of evaluation and checkups of independent training at home. The duration of participation is one year, with intervention once a month for about three times, and evaluation every three months.Nutritional guidance shall be provided once a month to ascertain dietary needs and provide individualized guidance. Intervention will be conducted once a month for about 3 times.
Interventions/Control_2
The control group will receive no intervention and will be checked for sarcopenia after one year.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Able to walk
2. Outpatients
Key exclusion criteria
1. Falls under high disease activity or moderate disease activity
2.No sarcopenia or risk of sarcopenia
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | mai |
| Middle name | |
| Last name | yamada |
Organization
Nagasaki Kita Hospital
Division name
Department of Rehabilitation
Zip code
851-2103
Address
800 Motomurago, Togitsu-cho, Nishisonogi-gun, Nagasaki 851-2103, Japan
TEL
+81-886-8700
kita_m_yamada@shunkaikai.jp
Public contact
Name of contact person
| 1st name | mai |
| Middle name | |
| Last name | yamada |
Organization
Nagasaki Kita Hospital
Division name
Department of Rehabilitation
Zip code
851-2103
Address
800 Motomurago, Togitsu-cho, Nishisonogi-gun, Nagasaki 851-2103, Japan
TEL
+81-886-8700
Homepage URL
http://www.shunkaikai.jp
kita_m_yamada@shunkaikai.jp
Sponsor or person
Institute
Nagasaki Kita Hospital
Institute
Department
Personal name
Mai Yamada
Funding Source
Organization
Nagasaki Kita Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki Kita Hospital
Address
800 Motomurago, Togitsu-cho, Nishisonogi-gun, Nagasaki 851-2103, Japan
Tel
+81-886-8700
kita_m_yamada@shunkaikai.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 | 01 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 12 | Day |
Last modified on
| 2023 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056986
