UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043871
Receipt No. 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

* 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 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
Email 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
Email hirokiyamauchi@gmail.com

Sponsor
Institute Kameda Medical Center
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050026

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.