UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036182 |
|---|---|
| Receipt number | 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 | 2023/03/16 17:12:49 |
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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
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
yee.yahho.jessie@gmail.com
Sponsor or person
Institute
Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
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
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
unpublished
Publication of results
Unpublished
Result
URL related to results and publications
unpublished
Number of participants that the trial has enrolled
39
Results
15 in the control group and 13 patients in the exercise instruction group were completed this study program.
In both groups, tender joint number, swollen joint number, erythrocyte sediment rate, DAS28-CRP and mHAQ were likely to be improved.
In addition, in the exercise instruction group, daily role (mental) and mental health in SF-36 was significantly improved after the exercise instruction compared to before the instruction.
Results date posted
| 2021 | Year | 10 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
39 subjects were admitted to our hospital for the initiation of biological agents. We randomly assigned these patients to control group and exercise instruction group.
Participant flow
We conducted guidance on living behavior in the control group, and 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 2to 4 times/week and continued to instruct these exercise for 3 months.
Adverse events
Adverse event related this exam were nothing in either group.
Outcome measures
We examined the disease activities, ADL and psychological assessment before and 3 months after the initiation of biologics treatment.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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 | 25 | 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
| 2023 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041221
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