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 |
Exercise therapy for rheumatoid arthritis patients tapering molecular targeted therapies.
Exercise therapy for rheumatoid arthritis
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.
Exercise therapy for rheumatoid arthritis patients tapering molecular targeted therapies.
Japan |
rheumatoid arthritis
Clinical immunology | Adult |
Others
NO
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.
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.
Exploratory
Explanatory
Not applicable
Disease activity of rheumatoid arthritis 16 weeks after the intervention.
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.
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
No treatment
YES
NO
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Behavior,custom |
Personalized Exercise therapy: load exercise 3 times a week for 30 minutes. The strength of the exercise are personally adjusted by Borg scale.
Control
18 | years-old | <= |
85 | years-old | > |
Male and Female
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.
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
30
1st name | MOTOMU |
Middle name | |
Last name | HASHIMOTO |
Osaka Metropolitan University
Department of Clinical Immunology
545-8585
1-4-3-13F, Asahi-machi, Abeno-ku, Osaka-shi, Osaka, 545-8585, Japan
06-6645-3981
motomu.hashimoto@omu.ac.jp
1st name | MOTOMU |
Middle name | |
Last name | HASHIMOTO |
Osaka Metropolitan University
Department of Clinical Immunology
545-8585
1-4-3-13F, Asahi-cho, Abeno-ku, Osaka-shi, Osaka, 545-8585, Japan
06-6645-3981
motomu.hashimoto@omu.ac.jp
Osaka Metropolitan University
Japan Agency for Medical Research and Development(grant number: 20ek0410069h0001)
Japanese Governmental office
JAPAN
Ethical Committee of Osaka Metropolitan University Graduate School of Medicine
AbenoMedix 6F, 1-2-7, Asahi-machi, Abeno-ku, Osaka-shi, Osaka, Japan
06-6645-3456
gr-a-knky-ethics@omu.ac.jp
NO
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
2022 | Year | 10 | Month | 17 | Day |
Unpublished
Not yet published
32
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]).
2024 | Year | 10 | Month | 15 | Day |
Delay expected |
The manuscript is under review.
RA patients who have achieved remission or low disease activity and started tapering molecular targeted therapies within one month were recruited.
The patients allocated to the intervention group performed personalized exercise program for 16 weeks.
No adverse events related to the study was recorded.
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]).
No longer recruiting
2022 | Year | 10 | Month | 07 | Day |
2022 | Year | 10 | Month | 07 | Day |
2022 | Year | 10 | Month | 19 | Day |
2023 | Year | 07 | Month | 31 | Day |
2022 | Year | 10 | Month | 14 | Day |
2024 | Year | 10 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055048