UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043871 |
|---|---|
| Receipt number | R000050026 |
| Scientific Title | Effects of blood flow restriction training on muscle atrophy in postoperative patient of knee osteoarthritis |
| Date of disclosure of the study information | 2021/05/01 |
| Last modified on | 2021/04/08 19:05:43 |
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Basic information
Public title
Investigating the effects of lower extremities blood flow restriction training on the muscles of postoperative knee joint patients
Acronym
Effects of blood flow restriction training
Scientific Title
Effects of blood flow restriction training on muscle atrophy in postoperative patient of knee osteoarthritis
Scientific Title:Acronym
Effects of blood flow restriction training in postoperative patients
Region
| Japan |
Condition
Condition
Knee osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of blood flow restriction training on muscle atrophy and strength of the thigh in postoperative patient with osteoarthritis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knee flexor and extensor strength (Preop., Postop 6Mo, Postop 1Y)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Usual rehabilitation and Blood flow restriction training
Interventions/Control_2
Usual 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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent surgery (high tibial osteotomy, cultured cartilage graft, osteochondral column graft, microfracture) at our hospital
Key exclusion criteria
- Unable to obtain consent for research
- If participants are under 20 years old and unable to obtain parental consent
- There are findings of a nerve problem in the lower extremities
- Previous history of surgery on the lower extremities
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Yamauchi |
Organization
Kameda Medical Center
Division name
Rehabilitation Department
Zip code
2960041
Address
1344, Higashi-cho, Kamogawa, Chiba
TEL
0470991111
hirokiyamauchi@gmail.com
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Yamauchi |
Organization
Kameda Medical Center
Division name
Rehabilitation Department
Zip code
2910041
Address
1344, Higashi-cho, Kamogawa, Chiba
TEL
0470991111
Homepage URL
hirokiyamauchi@gmail.com
Sponsor or person
Institute
Kameda Medical Center
Institute
Department
Personal name
Funding Source
Organization
Kameda Medical Center
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
Kameda Medical Center
Address
929, Higashi-cho, Kamogawa, Chiba
Tel
0470922211
clinical_research@kameda.jp
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
| 2021 | Year | 05 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 01 | 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
| 2021 | Year | 04 | Month | 08 | Day |
Last modified on
| 2021 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050026
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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