UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of High Intensity Exercises for improvement of Stair Climbing in Patients Undergone Total Knee Arthroplasty
Title of the study (Brief title)	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	Sadaya MISAKI
Organization	Sonodakai Joint Replacement Center Hospital
Division name	Department of Rehabilitation Medicine
Address	1-21-10, Hokima, Adachi, Tokyo
TEL	03-5831-1811
Email	s_misaki@sonodakai.or.jp

Public contact
Name of contact person	Sadaya MISAKI
Organization	Sonodakai Joint Replacement Center Hospital
Division name	Department of Rehabilitation Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000030356