UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018898 |
|---|---|
| Receipt number | R000021848 |
| Scientific Title | Effects of combined intervention of exercise and nutrient on physical function in knee osteoarthritis: a randomized double-blind, placebo-controlled, parallel-group study |
| Date of disclosure of the study information | 2016/07/31 |
| Last modified on | 2018/03/02 20:38:22 |
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Basic information
Public title
Effects of combined intervention of exercise and nutrient on physical function in knee osteoarthritis: a randomized double-blind, placebo-controlled, parallel-group study
Acronym
Effects of combined intervention of exercise and nutrient on physical function in knee osteoarthritis
Scientific Title
Effects of combined intervention of exercise and nutrient on physical function in knee osteoarthritis: a randomized double-blind, placebo-controlled, parallel-group study
Scientific Title:Acronym
Effects of combined intervention of exercise and nutrient on physical function in knee osteoarthritis
Region
| Japan |
Condition
Condition
Knee osteoarthritis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of combined intervention of exercise and nutrient on physical function in knee osteoarthritis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
JKOM score, Leg muscular power
Key secondary outcomes
physical performance test, cartilage metabolism markers, skeletal metabolism markers, inflammation markers, blood enzyme activities, blood hormone concentrations, blood metabolite concentrations
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food | Device,equipment | Behavior,custom |
Interventions/Control_1
Placebo drink(350ml/day for 12 weeks)+Daily exercise training for 12 weeks
Interventions/Control_2
Active drink(350ml/day for 12 weeks)+Daily exercise training for 12 weeks
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Knee OA subjects with Kellgren-Lawrence grade 2-3
Subjects who can perform muscle exercise
Subjects who can take test drinks for 12 weeks
Subjects who obtain doctor's permission for participation in this clinical study as a result of the medical examination
Subjects who can follow directions of medical workers in this clinical study
Key exclusion criteria
Subjects who had injury of locomotor organ including fracture, tendon rupture,muscle strain,and so on in last 1 year
Subjects who are not eligible due to physician's judgment
Subjects whose family member is related to the competitor of Kao Corporation.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Go Omori |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Sports, Faculty of Health and Science
Zip code
Address
1398-Banchi, Shimami-Cho, Kita-Ku, Niigata City, Niigata, JAPAN
TEL
+81-25-257-4672
omori@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Fushimi |
Organization
Kao Corporation
Division name
Biological Science Laboratory
Zip code
Address
2606 Akabane, Ichikai-Machi, Haga-Gun, Tochigi, Japan
TEL
+81-285-68-7769
Homepage URL
fushimi.takashi@kao.co.jp
Sponsor or person
Institute
Niigata Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
新潟リハビリテーション病院（新潟県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
-Exercise improved leg muscle power and walking capability, and reduced knee pain and blood oxidative marker.
-Nutrient additionally improved walking capability in mild knee OA subjects.
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
| 2014 | Year | 06 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 24 | Day |
Date of closure to data entry
| 2016 | Year | 07 | Month | 21 | Day |
Date trial data considered complete
| 2016 | Year | 09 | Month | 02 | Day |
Date analysis concluded
| 2016 | Year | 10 | Month | 17 | Day |
Other
Other related information
Jpn Pharmacol Ther 46(2):237-242. 2018
Management information
Registered date
| 2015 | Year | 09 | Month | 03 | Day |
Last modified on
| 2018 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021848
