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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026424
Receipt No. R000030356
Scientific Title Effectiveness of High Intensity Exercises for improvement of Stair Climbing in Patients Undergone Total Knee Arthroplasty
Date of disclosure of the study information 2017/03/06
Last modified on 2018/03/07

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Basic information
Public title Effectiveness of High Intensity Exercises for improvement of Stair Climbing in Patients Undergone Total Knee Arthroplasty
Acronym Effectiveness of High Intensity Exercises after Total Knee Arthroplasty
Scientific Title Effectiveness of High Intensity Exercises for improvement of Stair Climbing in Patients Undergone Total Knee Arthroplasty
Scientific Title:Acronym Effectiveness of High Intensity Exercises after Total Knee Arthroplasty
Region
Japan

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

Objectives
Narrative objectives1 Many of patients who had undergone total knee arthroplasty (TKA) remain of difficulty of stair climbing. Quadriceps muscle weakness is one of this reason. We hypothesize that high-intensity exercises are effective to improve quadriceps. The purpose of this study is to clarify effectiveness of high intensity exercises after total knee arthroplasty.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Japanese version Western Ontario and McMaster Universities Osteoarthritis Index
Key secondary outcomes Knee extension torque
Knee range of motion
Chair-standing test
Japanese version High-Activity Arthroplasty Score
Japanese version Forgotten Joint Score

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 High intensity exercises (muscle strengthening, balance, endurance training)
12 weeks, 1 or 2 times per week, 60-90 minutes per day
Interventions/Control_2 Standard exercises (muscle strengthening, balance, ADL training)
12 weeks, 1 or 2 times per week, 60-90 minutes per 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
50 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Osteoarthritis
primary surgery
PCL retaining type implant
unilateral or bilateral surgery
Key exclusion criteria 5 of 10 or more at rest pain
severe cardiovascular or nervous system disease
musculoskeletal disorder
cognitive disease
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sadaya MISAKI
Organization Sonodakai Joint Replacement Center Hospital
Division name Department of Rehabilitation Medicine
Zip code
Address 1-21-10, Hokima, Adachi, Tokyo
TEL 03-5831-1811
Email s_misaki@sonodakai.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sadaya MISAKI
Organization Sonodakai Joint Replacement Center Hospital
Division name Department of Rehabilitation Medicine
Zip code
Address 1-21-10, Hokima, Adachi, Tokyo
TEL 03-5831-1811
Homepage URL
Email s_misaki@sonodakai.or.jp

Sponsor
Institute Sonodakai Joint Replacement Center Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 03 Month 06 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 Completed
Date of protocol fixation
2015 Year 05 Month 22 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 01 Day
Last follow-up date
2018 Year 03 Month 07 Day
Date of closure to data entry
2018 Year 03 Month 07 Day
Date trial data considered complete
2018 Year 03 Month 07 Day
Date analysis concluded
2018 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 03 Month 06 Day
Last modified on
2018 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030356

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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