UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011033 |
|---|---|
| Receipt number | R000012919 |
| Scientific Title | Evaluation of physical therapy on physical function and QOL in patients with RA |
| Date of disclosure of the study information | 2013/07/01 |
| Last modified on | 2013/06/25 11:29:40 |
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Basic information
Public title
Evaluation of physical therapy on physical function and QOL in patients with RA
Acronym
Evaluation of physical therapy in RA
Scientific Title
Evaluation of physical therapy on physical function and QOL in patients with RA
Scientific Title:Acronym
Evaluation of physical therapy in RA
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology | Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of muscle training with high or low speed on physical function and QOL in patients with RA
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
a. QOL evaluated by SF-36
b. muscle strength of knee extension
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
A group will do muscle training with high speed
Interventions/Control_2
B group will do muscle training with low speed
Interventions/Control_3
C group will receive evaluation only.
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients diagnosed as RA by the classification criteria reported in 1988 or 2010
Key exclusion criteria
exclusion criteria are as follows: extensive ADL limitations (class IV), moderate or severe cognitive disability, or severe lung or heart disease
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromu Ito |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of the Control for Rheumatic Diseases
Zip code
Address
54, Kawahara-cho, Shogoin, Sakyo, Kyoto
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto University Hospital
Division name
Rheumatic Disease Center
Zip code
Address
54, Kawahara-cho, Shogoin, Sakyo, Kyoto
TEL
Homepage URL
Sponsor or person
Institute
Kyoto University Hospital, Rheumatic Disease Center
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
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
| 2013 | Year | 07 | 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
| 2013 | Year | 06 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 25 | Day |
Last modified on
| 2013 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012919
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
