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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032568
Receipt No. R000037142
Scientific Title Effect of Preoperative Rehabilitation in TKA Patients
Date of disclosure of the study information 2018/05/13
Last modified on 2018/05/13

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Basic information
Public title Effect of Preoperative Rehabilitation in TKA Patients
Acronym Effect of Preoperative Rehabilitation in TKA Patients
Scientific Title Effect of Preoperative Rehabilitation in TKA Patients
Scientific Title:Acronym Effect of 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 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The measurements is the physical activity in the daily living.
All patients included in the study are assessed 4 times: baseline is performed 3 week before surgery. The second testing is performed before surgery, and the third testing is executed 1 months after TKA, and the 4th testing is executed 3 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 Treatment
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 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasunori Umemoto
Organization Wakayama Medical University
Division name Rehabilitation
Zip code
Address 811-1 Kimiidera,Wakayama city,Japan
TEL 073-447-2300
Email r.comet06@gmail.com

Public contact
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
2018 Year 05 Month 13 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 Open public recruiting
Date of protocol fixation
2018 Year 03 Month 21 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 13 Day
Last modified on
2018 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037142

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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