UMIN-CTR Clinical Trial

Basic information
Public title	Effect of High-intensity and Short Term Preoperative Rehabilitation in TKA Patients
Acronym	Effect of High-intensity and Short Term Preoperative Rehabilitation in TKA Patients
Scientific Title	Effect of High-intensity and Short Term Preoperative Rehabilitation in TKA Patients
Scientific Title:Acronym	Effect of High-intensity and Short Term Preoperative Rehabilitation in TKA Patients
Region	Japan

Condition
Condition	Osteoarthritis of the knee
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the effectiveness of a high intensity and short term preoperative resistance training program in patients waiting for TKA.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The measurements are the physical activity and knee flexion angles in the daily living. All patients included in the study are assessed 5 times: baseline is performed 1 week before surgery. The second testing is performed 1 months after TKA, and the third testing is executed 3 months after TKA, and the 4th testing is executed 6 months after TKA, and the 5th testing is executed 12 months after TKA.
Key secondary outcomes	Other measurements are the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Physical Functioning Scale of the Short Form-36 questionnaire (SF-36), a 10-cm visual analogue scale (VAS), isometric strength (knee extension), passive knee ROM (flexion and extension) and gait function (Gait velocity, 6 minutes walking test).

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	The intervention group receives a training program prior to surgery for 3 days per week for 3 weeks. The exercise program is especially designed to increase lower limb muscle strength.
Interventions/Control_2	The control group does not preoperative rehabilitation.
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	95 years-old >=
Gender	Male and Female
Key inclusion criteria	All patients above 50 years old who are diagnosed with advanced idiopathic or rheumatoid arthritis knee osteoarthritis (OA) (according to the radiological criteria of the American College of Rheumatology Guidelines) and schedules for unilateral or bilateral total knee arthroplasty (TKA) in our hospital are considered candidates for the present study and are asked to participate.
Key exclusion criteria	Patients are excluded: 1) active or recently treated infections, 2) unable to walk independently or with supervision for 6 minutes, 3) any medical condition in which exercise is contraindicated.
Target sample size	50

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Yukihide Nishimura
Organization	Iwate Medical University
Division name	rehabilitaion
Zip code
Address	19-1 uchimaru,Morioka city Japan
TEL	019-651-5111
Email	ynishi@iwate-med.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Chigusa Ohno
Organization	Wakayama Medical University
Division name	Rehabilitation
Zip code
Address	811-1 Kimiidera,Wakayama city,Japan
TEL	073-447-2300
Homepage URL
Email	chigusaann@yahoo.co.jp

Sponsor
Institute	Department of Rehabilitation Medicine Wakayama Medical University
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 04 Month 30 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	2016 Year 09 Month 01 Day
Date of IRB	2016 Year 09 Month 16 Day
Anticipated trial start date	2017 Year 04 Month 30 Day
Last follow-up date	2018 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 04 Month 30 Day
Last modified on	2019 Year 04 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031164