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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000035957
Receipt No. R000040949
Scientific Title Effects of neuromuscular electrical stimulation of quadriceps force and oral administration of branched-chain amino acid in patients after Living-donor liver transplantation
Date of disclosure of the study information 2019/04/01
Last modified on 2019/03/08

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Basic information
Public title Effects of neuromuscular electrical stimulation of quadriceps force and oral administration of branched-chain amino acid in patients after Living-donor liver transplantation
Acronym Effects of neuromuscular electrical stimulation and branched chain amino acid in patients after Living-donor liver transplantation
Scientific Title Effects of neuromuscular electrical stimulation of quadriceps force and oral administration of branched-chain amino acid in patients after Living-donor liver transplantation
Scientific Title:Acronym Effects of neuromuscular electrical stimulation and branched chain amino acid in patients after Living-donor liver transplantation
Region
Japan

Condition
Condition Patients after Living-donor liver transplantation
Classification by specialty
Hepato-biliary-pancreatic medicine Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effects of neuromuscular electrical stimulation and oral administration of branched-chain amino acid on quadriceps force
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Quadriceps force
Key secondary outcomes An activity of daily living,
Postoperative day

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Intervention group:
We used electrical muscle stimulation.
Stimulation region: Quadriceps muscle
Intensity: Symmetrical biphasic square pulsed current at 45 Hz
Pulse: 400 ms
Duty cycle: 12 sec on and 6 sec off
Intensity: 40-80 mA
Time: 45 min 1session 5time per week

BCAA; Aminoleban
Dose frequency; after every meal
administration period; 1 month after LDLT
Interventions/Control_2
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The adult patient that is possible to evaluated in patients of preoperative living doner liver transplantation.
Informed consent was obtained from all
patients prior to participation in the study.
Key exclusion criteria 1) Musculoskeletal impairment
2) Cerebral vascular disorder
3) Severe visually and hearing impairment
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisamitsu Miyaaki
Organization Nagasaki University Hospital
Division name Department of gastroenterology and Hepatology
Zip code
Address 1-7-1 Sakamoto, Nagasaki
TEL 095-819-7481
Email miyaaki-hi@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masafumi Haraguchi
Organization Nagasaki University Hospital
Division name Department of gastroenterology and Hepatology
Zip code
Address 1-7-1 Sakamoto, Nagasaki
TEL 095-819-7481
Homepage URL
Email mharaguchi@nagasaki-u.ac.jp

Sponsor
Institute Department of gastroenterology and Hepatology, Nagasaki University Hospital
Institute
Department

Funding Source
Organization Department of gastroenterology and Hepatology, Nagasaki University Hospital
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
Email

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
2019 Year 04 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 Terminated
Date of protocol fixation
2019 Year 03 Month 28 Day
Date of IRB
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 02 Month 20 Day
Last modified on
2019 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040949

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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