UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057839 |
|---|---|
| Receipt number | R000066115 |
| Scientific Title | Effect of pedaling exercise early after total knee arthroplasty: A Stratified Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/05/31 |
| Last modified on | 2025/05/12 17:28:11 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of pedaling exercise early after total knee arthroplasty: A Stratified Randomized Controlled Trial
Acronym
Effect of pedaling exercise early after TKA: A Stratified Randomized Controlled Trial
Scientific Title
Effect of pedaling exercise early after total knee arthroplasty: A Stratified Randomized Controlled Trial
Scientific Title:Acronym
Effect of pedaling exercise early after TKA: A Stratified Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Knee osteoarthritis
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effect of pedaling exercise in the early period following total knee arthroplasty on walking ability.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in Timed Up and Go test score between preoperative assessment and 2 weeks postoperatively
Key secondary outcomes
Knee joint range of motion (flexion, extension), isometric knee joint extension strength, knee pain (NRS),Japanese version of the Western Ontario and McMaster Universities Osteoarthritis Index, Japanese version of the Forgotten Joint Score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
pedaling exercise
Interventions/Control_2
control
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
| 55 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The primary disease is osteoarthritis of the knee
Underwent primary unilateral or simultaneous bilateral total knee arthroplasty
55-85 years old
Able to ambulate independently or with a cane preoperatively
Key exclusion criteria
Patients who deviated from the standard rehabilitation protocol of our institution
Patients with intraoperative knee flexion less than 90 degrees
Patients with dementia
Patients with cerebrovascular or neuromuscular disorders
Patients who underwent orthopedic surgery on other lower limb joints
Patients who underwent revision TKA
Patients with signs of infection
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Kawashima |
Organization
Sonodakai Joint Replacement Center Hospital
Division name
Rehabilitation
Zip code
121-0064
Address
2-21-10 Hokima,Adachiku,Tokyo
TEL
03-5831-1811
kawashi33374@gmail.com
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Kawashima |
Organization
Sonodakai Joint Replacement Center Hospital
Division name
Rehabilitation
Zip code
121-0064
Address
2-21-10 Hokima,Adachiku,Tokyo
TEL
03-5831-1811
Homepage URL
kawashi33374@gmail.com
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sonodakai Joint Replacement Center Hospital
Address
2-21-10 Hokima,Adachiku,Tokyo
Tel
03-5831-1811
kawashi33374@gmail.com
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
| 2025 | Year | 05 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 12 | Day |
Last modified on
| 2025 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066115
