UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051604 |
|---|---|
| Receipt number | R000058882 |
| Scientific Title | Effectiveness of pedaling exercises in the early postoperative period after Total Knee Arthroplasty |
| Date of disclosure of the study information | 2023/07/15 |
| Last modified on | 2023/07/14 22:56:42 |
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Basic information
Public title
Effectiveness of pedaling exercises in the early postoperative period after Total Knee Arthroplasty
Acronym
Efficacy of Pedaling Exercises for Post-TKA Patients
Scientific Title
Effectiveness of pedaling exercises in the early postoperative period after Total Knee Arthroplasty
Scientific Title:Acronym
Efficacy of Pedaling Exercises for Post-TKA Patients
Region
| Japan |
Condition
Condition
after Total Knee Arthroplasty patients
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effectiveness of pedaling exercises in the early postoperative period after total knee arthroplasty (TKA).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Health-related Quality of Life
Key secondary outcomes
Pain, physical activity, 10m walking speed, stride length, cadence, timed up and go test, flexion and extension ROM and isometric flexion and extension strength at affected side
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention group will receive traditional rehabilitation such as range of motion (ROM) exercises and strength training. Additionally, pedaling exercises twice a day to discharge and 4 types of self-training (ROM exercise, straight leg raising, stretching of gastrocnemius muscle, hip lift).
Interventions/Control_2
The control group will receive conventional rehabilitation such as range of motion (ROM) exercises and strength training, as well as four types of self-training (ROM exercises, straight leg raises, gastrocnemius stretches, and hip lifts).
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
Patients with osteoarthritis of the knee scheduled for initial total knee arthroplasty
Key exclusion criteria
Postoperative lumbar spine cases, patients with a history of surgery for lower limb diseases other than knee OA, patients who have difficulty walking on their own with a cane or by themselves before surgery, rheumatoid arthritis cases, cases with neurological diseases, dementia.
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Wataru |
| Middle name | |
| Last name | Iriyama |
Organization
Keiyu Orthopedic Hospital
Division name
Department of Rehabilitation
Zip code
374-0013
Address
2267-1 Akauda-cho, Tatebayashi City, Gunma, Japan
TEL
0276499000
iriwata5323@gmail.com
Public contact
Name of contact person
| 1st name | Wataru |
| Middle name | |
| Last name | Iriyama |
Organization
Keiyu Orthopedic Hospital
Division name
Department of Rehabilitation
Zip code
374-0013
Address
2267-1 Akauda-cho, Tatebayashi City, Gunma, Japan
TEL
0276499000
Homepage URL
iriwata5323@gmail.com
Sponsor or person
Institute
Keiyu Orthopedic Hospital
Institute
Department
Personal name
Funding Source
Organization
Keiyu Orthopedic Hospital
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
Keiyu Orthopedic Hospital
Address
2267-1 Akauda-cho, Tatebayashi City, Gunma, Japan
Tel
0276499000
iriwata5323@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
| 2023 | Year | 07 | Month | 15 | 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
52
Results
Than the control group, in the intervention group 10m walking speed were faster and cadence was greater. Other items showed no significant differences.
Results date posted
| 2023 | Year | 07 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
No
Outcome measures
Pain, physical activity, health-related Quality of Life, 10m walking speed, stride length, cadence, timed up and go test, flexion and extension ROM and isometric flexion and extension strength at affected side
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 03 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2023 | Year | 07 | Month | 13 | Day |
Last modified on
| 2023 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058882
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