UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044930 |
|---|---|
| Receipt number | R000051320 |
| Scientific Title | Effect of personalized exercise program on physical performance in patients with rheumatoid arthritis aged 60-75: a randomized control trial |
| Date of disclosure of the study information | 2022/01/04 |
| Last modified on | 2023/07/25 17:12:49 |
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Basic information
Public title
Effect of personalized exercise program on physical performance in patients with rheumatoid arthritis aged 60-75: a randomized control trial
Acronym
Effect of personalized exercise program on physical performance in patients with rheumatoid arthritis aged 60-75: a randomized control trial
Scientific Title
Effect of personalized exercise program on physical performance in patients with rheumatoid arthritis aged 60-75: a randomized control trial
Scientific Title:Acronym
Effect of personalized exercise program on physical performance in patients with rheumatoid arthritis aged 60-75: a randomized control trial
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of personalized exercise on physical performance in patients with rheumatoid arthritis aged 60-75.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Short Physical Performance Battery (SPPB) at 4 months after randomization
Key secondary outcomes
1. SPPB components: balance test, gait test, chair rise test
2. Grip strength
3. skeletal muscle mass
4. Physical activity (activity meter, IPAQ)
5. Disease activity of rheumatoid arthritis: Disease Activity Score 28 joints (DAS28), Clinical Disease Activity Index (CDAI), Simplified Disease activity Index (SDAI)
6. Physical disability: Health Assessment Questionnaire (HAQ)
7. General health-related QOL: EuroQol-5Dimension (EQ-5D), 12-Item Short-Form Health Survey (SF-12)
8. Subjective depression and anxiety symptoms: Hospital Anxiety and Depression Scale (HADS)
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
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Personalized exercise (4 months)
Interventions/Control_2
Usual care
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
| 60 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Age between 60 and 75 years at the time of consent/enrollment date.
2. Participants who have been diagnosed with rheumatoid arthritis by their physician at the time of baseline assessment.
3. Participants who are positive on the sarcopenia screening test
4.Those who are able and willing to make continuous visits to the implementing facility.
5.Those who are able to communicate, read and write in Japanese.
6.A person who understands the purpose and content of this study and can give written consent to participate in the study of his/her own free will.
Key exclusion criteria
1. Patients who have difficulty walking independently or standing up, at the time of baseline assessment
2. Patients who have been instructed by their physician to limit their exercise at the time of the baseline assessment
3. Patients with a pacemaker at baseline assessment
4. Patients with cognitive impairment (MMSE <=23) at baseline assessment.
5.Others, who are judged by the principal investigator or sub-investigator to be inappropriate for this study
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Mie |
| Middle name | |
| Last name | Torii |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Human Health Sciences
Zip code
606-8507
Address
53 Kawahara-cho, Shogoin,Sakyo-Ku, Kyoto
TEL
0757513927
torii.mie.4x@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Mie |
| Middle name | |
| Last name | Torii |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Human Health Sciences
Zip code
606-8507
Address
53 Kawahara-cho, Shogoin,Sakyo-Ku, Kyoto
TEL
075-751-3927
Homepage URL
torii.mie.4x@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine, Department of Human Health Sciences.
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University
Address
Yoshida Konoe-cho, Sakyo-Ku,Kyoto city
Tel
075-753-4680
ethcom@kuhp.kyoto-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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 04 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 20 | 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
| 2021 | Year | 07 | Month | 21 | Day |
Last modified on
| 2023 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051320
