UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049223 |
|---|---|
| Receipt number | R000055048 |
| Scientific Title | The effect of personalized exercise therapy on disease activity of rheumatoid arthritis patients who achieved remission or low disease activity and started tapering molecular targeted therapies: a randomized controlled pilot study. |
| Date of disclosure of the study information | 2022/10/17 |
| Last modified on | 2024/10/15 15:36:03 |
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Basic information
Public title
Exercise therapy for rheumatoid arthritis patients tapering molecular targeted therapies.
Acronym
Exercise therapy for rheumatoid arthritis
Scientific Title
The effect of personalized exercise therapy on disease activity of rheumatoid arthritis patients who achieved remission or low disease activity and started tapering molecular targeted therapies: a randomized controlled pilot study.
Scientific Title:Acronym
Exercise therapy for rheumatoid arthritis patients tapering molecular targeted therapies.
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effect of personalized exercise therapy on disease activity of rheumatoid arthritis patients who achieved remission or low disease activity and started tapering molecular targeted therapies.
Basic objectives2
Others
Basic objectives -Others
Evaluated the effect of personalized exercise therapy on disease activity of rheumatoid arthritis patients who achieved remission of low disease activity and started tapering molecular targeted therapies.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Disease activity of rheumatoid arthritis 16 weeks after the intervention.
Key secondary outcomes
Maintenance rate of remission or low disease activity with tapered dose of molecular targeted therapies 16 weeks after the intervention.
QOL of RA patients 16 weeks after the intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Personalized Exercise therapy: load exercise 3 times a week for 30 minutes. The strength of the exercise are personally adjusted by Borg scale.
Interventions/Control_2
Control
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with rheumatoid arthritis who achieved remission or low disease activity with regular dose of molecular targeted therapies (b-DMARDs or ts-DMARDs) and initiated tapering molecular targeted therapies (dose reduction or spacing) within 3 months before the informed consent.
Patients who can attend the hospital regularly.
Patients who can read and understand Japanese language.
Patients who provide a written informed consent for this study.
Key exclusion criteria
Patients who cannot stand or walk.
Patients who are not allow to do exercise by the physician.
Patients who have cognitive impairment.
Patients for whom physicians judge as inappropriate to join this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | MOTOMU |
| Middle name | |
| Last name | HASHIMOTO |
Organization
Osaka Metropolitan University
Division name
Department of Clinical Immunology
Zip code
545-8585
Address
1-4-3-13F, Asahi-machi, Abeno-ku, Osaka-shi, Osaka, 545-8585, Japan
TEL
06-6645-3981
motomu.hashimoto@omu.ac.jp
Public contact
Name of contact person
| 1st name | MOTOMU |
| Middle name | |
| Last name | HASHIMOTO |
Organization
Osaka Metropolitan University
Division name
Department of Clinical Immunology
Zip code
545-8585
Address
1-4-3-13F, Asahi-cho, Abeno-ku, Osaka-shi, Osaka, 545-8585, Japan
TEL
06-6645-3981
Homepage URL
motomu.hashimoto@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development(grant number: 20ek0410069h0001)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Osaka Metropolitan University Graduate School of Medicine
Address
AbenoMedix 6F, 1-2-7, Asahi-machi, Abeno-ku, Osaka-shi, Osaka, Japan
Tel
06-6645-3456
gr-a-knky-ethics@omu.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
大阪公立大学医学部附属病院、京都大学医学部附属病院、大阪赤十字病院、関西医科大学医学部附属病院、大阪医科薬科大学附属病院、神戸大学医学部附属病院、奈良県立医科大学、大阪大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Not yet published
Number of participants that the trial has enrolled
32
Results
A total of 32 patients were allocated into the two groups. The difference in the least-squares mean change in DAS28-ESR at week 16 from baseline between the two groups (intervention minus control) was 0.40 points (95% confidence interval [CI], -0.09 to 0.88). The proportion of patients who retained remission or LDA tended to be lower in the intervention group than in the control group (75.0% vs. 86.7%; difference, -11.7% [95% CI, -38.0 to 17.0]).
Results date posted
| 2024 | Year | 10 | Month | 15 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The manuscript is under review.
Date of the first journal publication of results
Baseline Characteristics
RA patients who have achieved remission or low disease activity and started tapering molecular targeted therapies within one month were recruited.
Participant flow
The patients allocated to the intervention group performed personalized exercise program for 16 weeks.
Adverse events
No adverse events related to the study was recorded.
Outcome measures
A total of 32 patients were allocated into the two groups. The difference in the least-squares mean change in DAS28-ESR at week 16 from baseline between the two groups (intervention minus control) was 0.40 points (95% confidence interval [CI], -0.09 to 0.88). The proportion of patients who retained remission or LDA tended to be lower in the intervention group than in the control group (75.0% vs. 86.7%; difference, -11.7% [95% CI, -38.0 to 17.0]).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 07 | 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
| 2022 | Year | 10 | Month | 14 | Day |
Last modified on
| 2024 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055048
