UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053230 |
|---|---|
| Receipt number | R000060749 |
| Scientific Title | Investigation of the effectiveness of knee pain-focused and exercise-confidence-focused exercise |
| Date of disclosure of the study information | 2023/12/26 |
| Last modified on | 2023/12/27 13:50:53 |
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Basic information
Public title
Investigation of the effectiveness of group exercise for people with knee pain
Acronym
Investigation of the effectiveness of group exercise for people with knee pain
Scientific Title
Investigation of the effectiveness of knee pain-focused and exercise-confidence-focused exercise
Scientific Title:Acronym
Investigation of the effectiveness of knee pain-focused and exercise-focused exercise
Region
| Japan |
Condition
Condition
knee osteoarthritis
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate which treatment is more effective for knee osteoarthritis pain: exercise intervention in which participants exercise daily while checking their pain status, or exercise intervention in which participants exercise while checking their exercise confidence level.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
knee pain intensity(VAS),ICOAP,KOOS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
The participants make a daily note in a notebook about the intensity and quality of knee pain during physical activities in a day.
Interventions/Control_2
The participants make a daily note in a notebook about the context and intensity of self-efficacy during physical activities in a day.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Independence in daily living
Persons with knee pain
Those who meet the diagnostic criteria for osteoarthritis of the knee from the American College of Rheumatology
Key exclusion criteria
History of cerebrovascular disease
Post-artificial knee joint replacement
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Ogaya |
Organization
Saitama Prefectural University
Division name
Department of physical therapy
Zip code
3438540
Address
820 Sannomiya, Koshigaya-shi, Saitama, Japan
TEL
048-971-0500
ogaya-shinya@spu.ac.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Ogaya |
Organization
Saitama Prefectural University
Division name
Department of physical therapy
Zip code
3438540
Address
820 Sannomiya, Koshigaya-shi, Saitama, Japan
TEL
048-971-0500
Homepage URL
ogaya-shinya@spu.ac.jp
Sponsor or person
Institute
Saitama Prefectural University
Institute
Department
Personal name
Funding Source
Organization
Saitama Prefectural University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Prefectural University
Address
820 Sannomiya, Koshigaya-shi, Saitama, Japan
Tel
048-971-0500
ogaya-shinya@spu.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
| 2023 | Year | 12 | Month | 26 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 26 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 12 | Month | 26 | Day |
Last modified on
| 2023 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060749
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
