UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035957 |
|---|---|
| Receipt number | 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 10:48:29 |
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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
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
mharaguchi@nagasaki-u.ac.jp
Sponsor or person
Institute
Department of gastroenterology and Hepatology, Nagasaki University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040949
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
