UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of neuromuscular electrical stimulation of quadriceps force and oral administration of branched-chain amino acid in patients after Living-donor liver transplantation
Title of the study (Brief title)	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	Hisamitsu Miyaaki
Organization	Nagasaki University Hospital
Division name	Department of gastroenterology and Hepatology
Address	1-7-1 Sakamoto, Nagasaki
TEL	095-819-7481
Email	miyaaki-hi@umin.ac.jp

Public contact
Name of contact person	Masafumi Haraguchi
Organization	Nagasaki University Hospital
Division name	Department of gastroenterology and Hepatology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2019 Year 03 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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