UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006178 |
|---|---|
| Receipt number | R000007201 |
| Scientific Title | Effect of home-based quadriceps muscle strengthening and range of motion exercises for knee osteoarthritis, A randomized controlled trial ; motor function in lower extrimities, ADL and mental state |
| Date of disclosure of the study information | 2011/08/19 |
| Last modified on | 2016/02/26 23:13:36 |
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Basic information
Public title
Effect of home-based quadriceps muscle strengthening and range of motion exercises for knee osteoarthritis,
A randomized controlled trial ;
motor function in lower extrimities,
ADL and mental state
Acronym
Effect of home-based quadriceps muscle strengthening and range of motion exercises for knee osteoarthritis,
A randomized controlled trial ;
motor function in lower extrimities,
ADL and mental state
Scientific Title
Effect of home-based quadriceps muscle strengthening and range of motion exercises for knee osteoarthritis,
A randomized controlled trial ;
motor function in lower extrimities,
ADL and mental state
Scientific Title:Acronym
Effect of home-based quadriceps muscle strengthening and range of motion exercises for knee osteoarthritis,
A randomized controlled trial ;
motor function in lower extrimities,
ADL and mental state
Region
| Japan |
Condition
Condition
osteoarthritis of knee
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of home-based exercise and pharmacological modalities of treatment for knee OA.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Japanse Knee Osteoarthritis Measure: JKOM
2) measurement of values of blood count, ESR, hs-CRP, HA, IL-6, IL1ra
3)Self-rating Depression Scale:SDS
4)Timed Up and Go Test, Timed one foot standing test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
NS:Non-steriodal anti-inflammatory drugs (NSAIDs) celecoxib, 200mg/day for 12 weeks
Interventions/Control_2
HA:intra-articular injecion of hyaluronate acid
high molecular weight 2700kDa HA, 5 times with one week interval
Interventions/Control_3
EX:daily exercise
Interventions/Control_4
NS+HA::Non-steriodal anti-inflammatory drugs (NSAIDs) and intra-articular injecion of hyaluronate acid
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
patients with osteoarthritis of the knee
(Kellgren/Lawrence stage II III IV )
Key exclusion criteria
1) Patients who had treatment for their knee at other hospital or clinic, i.e., who received therapeutic exercise, intraarticular injection, or NSAIDs within 4 weeks before the day to start the trial.
2) Patients who had done or planned operation against the knee.
3) Patients who have diseases requiring regular or intermittent use of steroid or non-steroidal anti-inflammatory drugs.
4) Patients who have articular cartilage injury or history of damage due to obvious trauma or septic arthritis.
5) Patients who were diagnosed as rheumatoid arthritis, gout, pseudogout, or collagen diseases.
6) Patients with cardiac, liver, or renal dysfunction.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukio Shimura |
Organization
Juntendo Tokyo Koto Geriatric Medical Center
Division name
orthopeadic
Zip code
Address
3-3-20, Shinsuna, Koto, Tokyo
TEL
0356323111
shimura@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukio Shimura |
Organization
Juntendo Tokyo Koto Geriatric Medical Center
Division name
Orthopeadics
Zip code
Address
3-3-20, Shinsuna, Koto, Tokyo
TEL
0356323111
Homepage URL
shimura@juntendo.ac.jp
Sponsor or person
Institute
Juntendo Tokyo Koto Geriatric Medical Center
Institute
Department
Personal name
Funding Source
Organization
Juntendo Tokyo Koto Geriatric Medical Center
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
Address
Tel
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
| 2011 | Year | 08 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.oarsijournal.com/article/S1063-4584(15)00765-7/abstract
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
Completed
Date of protocol fixation
| 2011 | Year | 08 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 09 | Month | 11 | Day |
Date trial data considered complete
| 2015 | Year | 09 | Month | 11 | Day |
Date analysis concluded
| 2015 | Year | 09 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 16 | Day |
Last modified on
| 2016 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007201
| 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 |
