UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027198 |
|---|---|
| Receipt number | R000031164 |
| Scientific Title | Effect of High-intensity and Short Term Preoperative Rehabilitation in TKA Patients |
| Date of disclosure of the study information | 2017/04/30 |
| Last modified on | 2019/04/29 13:19:44 |
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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
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
ynishi@iwate-med.ac.jp
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
chigusaann@yahoo.co.jp
Sponsor or person
Institute
Department of Rehabilitation Medicine Wakayama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031164
