UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of the effects of leucine intake in standing up training
Title of the study (Brief title)	A study of the effects of leucine intake in standing up training
Region	Japan

Condition
Condition	rehabilitation patients
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to examine the effect of leucine intake in standing up training, which has main role in muscle protein synthesis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	changes of the muscle mass in 6 months
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	standing up training plus leucine intake
Interventions/Control_2	standing up traning alone
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	adult
Key exclusion criteria	over 1.1mg/dL in male, and over 0.7mg/dL in female for Cre under 60 for eGFR
Target sample size	100

Research contact person
Name of lead principal investigator	Kenji Tada
Organization	Shimonoseki Rehabilitation Hospital
Division name	rehabilitation
Address	Imauracho 9-6, Shimonoseki, Yamaguchi, Japan
TEL	0832325811
Email	Kmttada@aol.com

Public contact
Name of contact person	Kenji Tada
Organization	Shimonoseki Rehabilitation Hospital
Division name	rehabilitation
Address	Imauracho 9-6, Shimonoseki, Yamaguchi, Japan
TEL	0832325811
Homepage URL
Email	Kmttada@aol.com

Sponsor
Institute	Shimonoseki Rehabilitation Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Shimonoseki Rehabilitation Hospital
Organization
Division
Category of Funding Organization	Other
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	2016 Year 07 Month 31 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 07 Month 31 Day
Anticipated trial start date	2016 Year 07 Month 27 Day
Last follow-up date	2017 Year 01 Month 31 Day
Date of closure to data entry	2017 Year 02 Month 28 Day
Date trial data considered complete	2017 Year 02 Month 28 Day
Date analysis concluded	2017 Year 03 Month 31 Day

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

Management information
Registered date	2016 Year 07 Month 27 Day
Last modified on	2016 Year 07 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026871