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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035225
Receipt No. R000036946
Scientific Title Effectiveness of Supervised Exercise Therapy for Community-dwelling People with Chronic Knee Pain:a randomised controlled trial.
Date of disclosure of the study information 2018/12/11
Last modified on 2019/05/08

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Basic information
Public title Effectiveness of Supervised Exercise Therapy for Community-dwelling People with Chronic Knee Pain:a randomised controlled trial.
Acronym Chronic Knee Pain & Supervised Exercise Therapy
Scientific Title Effectiveness of Supervised Exercise Therapy for Community-dwelling People with Chronic Knee Pain:a randomised controlled trial.
Scientific Title:Acronym Chronic Knee Pain & Supervised Exercise Therapy
Region
Japan

Condition
Condition Chronic Knee Pain
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate effectiveness of supervised exercise therapy for community-dwelling people with chronic knee pain.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Knee injury and Osteoarthritis Outcome Score (KOOS)
Key secondary outcomes Numerical Rating Scale(NRS); Self-Efficasy, Pain Self-Efficasy Questionnaire; QOL, EuroQol 5 Dimension

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Supervised exercise therapy for chronic knee pain with textbook use, intervention period: about 1 month
Interventions/Control_2 only textbook use and/or 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
40 years-old <=
Age-upper limit
79 years-old >=
Gender Male and Female
Key inclusion criteria Participants of annual health check survey, who have reported chronic knee pain
Key exclusion criteria Those suspected of pain by rheumatism etc.
Those planned for knee surgery or Those with knee surgery history
Thoese judged unsuitable for exercise by a doctor.
Those who have difficulty answering questionnaire.
Target sample size 44

Research contact person
Name of lead principal investigator
1st name Jinnouchi
Middle name
Last name Hiroshige
Organization Nippon Medical School
Division name Hygiene & Public Health
Zip code 113-8602
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8602, Japan
TEL 03-3822-2131
Email h-jinnouchi@nms.ac.jp

Public contact
Name of contact person
1st name Jinnouchi
Middle name
Last name Hiroshige
Organization Nippon Medical School
Division name Hygiene and Public Health
Zip code 113-8602
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8602, Japan
TEL 03-3822-2131
Homepage URL
Email h-jinnouchi@nms.ac.jp

Sponsor
Institute Nippon Medical School
Institute
Department

Funding Source
Organization Fullhap
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor Collaborating research institutes: Osaka Center for Cancer and Cardiovascular Disease Prevention/ Tokyo Metropolitan Institute of Gerontology. Cooperating Research Institute: Graduate School of Medicine, Osaka University/22nd Century Medical and Research Center, The University of Tokyo.
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of Nippon Medical School
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8602, Japan
Tel 03-5802-8202
Email officetokutei@nms.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
2018 Year 12 Month 11 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 46
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
2018 Year 07 Month 30 Day
Date of IRB
2018 Year 04 Month 05 Day
Anticipated trial start date
2018 Year 07 Month 30 Day
Last follow-up date
2019 Year 12 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
2018 Year 12 Month 11 Day
Last modified on
2019 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036946

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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