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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036182
Receipt No. R000041221
Scientific Title Combination effect of exercise instruction and biologics on rheumatoid arthritis patients. -a randomized controlled trial-
Date of disclosure of the study information 2019/03/13
Last modified on 2019/03/13

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Basic information
Public title Combination effect of exercise instruction and biologics on rheumatoid arthritis patients. -a randomized controlled trial-
Acronym Combination effect of exercise instruction and biologics on rheumatoid arthritis patients. -a randomized controlled trial-
Scientific Title Combination effect of exercise instruction and biologics on rheumatoid arthritis patients. -a randomized controlled trial-
Scientific Title:Acronym Combination effect of exercise instruction and biologics on rheumatoid arthritis patients. -a randomized controlled trial-
Region
Japan

Condition
Condition rheumatoid arthritis
Classification by specialty
Clinical immunology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the appropriate exercise instruction method for RA patients simultaneously starting Bio and to clarify the effect through multifaceted evaluation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes knee extension muscle strength and 6 minute-walk test before and 3 months after the introduction of biological agents
Key secondary outcomes DAS28-CRP,C-reactive protein,Erythrocyte sedimentation rate,White blood cell,Swollen joint number,Tender joint number,Visual Analogue Scale,Grip,Pinch strength,modified Health Assessment Questionnaire(mHAQ),MOS36-Item Short-Form Health Survey(SF-36)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 We conducted guidance on living behavior in the control group.
Interventions/Control_2 We instructed walking and standing sitting exercise in addition to living action instruction to the exercise instruction group. We conducted exercise intensity of modified Borg Scale 2 to 3 at a frequency of twice to 4 times/week and continued to instruct these exercise for 3 months.
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

Not applicable
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1.RA diagnosed according to ACR/EULAR2010 revised criteria
2.RA patient who treated with Bio for the first time
3.Age<80 years old
4.Patients for whom written consent was obtained
5.Patients with class I to III of ACR functional classification
6.Patients who have been taking antirheumatic drugs (DMARDs) for the past 3 months
7.Patients who can walk for 10 minutes or more
8.Patients who can fully answer the questionnaire
Key exclusion criteria 1.Patients judged by the attending physician as inappropriate for research
2.ACR functional classification class IV patients
3.Patients with high degree of joint deformity
4.Patients whose treatment for rheumatoid arthritis changed during the study period
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Kaori
Middle name
Last name Yoshida
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Locomotive Rehabilitation Science, Unit of Rehabilitation Sciences
Zip code 852-8520
Address 1-7-1 Sakamoto Nagasaki, Japan
TEL 095-819-7919
Email yee.yahho.jessie@gmail.com

Public contact
Name of contact person
1st name Kaori
Middle name
Last name Yoshida
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Locomotive Rehabilitation Science, Unit of Rehabilitation Sciences
Zip code 852-8520
Address 1-7-1 Sakamoto Nagasaki, Japan
TEL 095-819-7919
Homepage URL
Email yee.yahho.jessie@gmail.com

Sponsor
Institute Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagasaki University Graduate School of Biomedical Sciences and Technology Cooperation Division
Address 1-12-4 Sakamoto Nagasaki, Japan
Tel 095-819-7195
Email gakujutu_gakuji@ml.nagasaki-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 日本赤十字社長崎原爆病院(長崎県)

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 13 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2015 Year 10 Month 23 Day
Date of IRB
2015 Year 10 Month 23 Day
Anticipated trial start date
2016 Year 04 Month 05 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 03 Month 13 Day
Last modified on
2019 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041221

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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