UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of leucine high formulated nutritional supplementation on physical function, skeletel muscle mass and muscle strengh with resistance traiing for inpatient disabled elderly in convalescent rehabilitation - a randomized controlled trial
Title of the study (Brief title)	The effect of leucine high formulated nutritional supplementation on physical function
Region	Japan

Condition
Condition	sarcopenia with disability
Classification by specialty	Geriatrics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of a combination of leucine high formulated nutritional supplementation and resistance training on physical activity, skeletal muscle mass and muscle strength in elderly inpatients with disabilities in a convalescent rehabilitation setting.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	The change in Physical activity. Measured by Functional Independence Measure (FIM)
Key secondary outcomes	1.Muscle mass (Skeletal muscle mass index detected using BIA, AMA,AC,AMC,CC measured by anthropometric method) 2.Muscle strength (hand grip strengh) 3.Nutritional assessment (MNA-SF,BMI,Alb,Hb,T-Cho,TLC,BUN,Cr,vitamin-D,CRP,body cell mass) 4.Plasma free amino acid profile 5.25(OH)D

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	1.Leucin high formulated nutritional supplement 2.Group sit-stand trainig
Interventions/Control_2	1.Group sit-stand trainig
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Elderly patients aged 65 yo and over hospitalized in a rehabilitation ward 1.Undergoing group stand-sit training 3.Appropriate nutritional management 4.Able to start group stand-sit training
Key exclusion criteria	1.Disturbance of consciousness 2.Severe dementia 3.Disability of oralintake 4.Severe renal dysfunction 5.Medically considered inappropriate condition
Target sample size	60

Research contact person
Name of lead principal investigator	Yoshihiro Yoshimura
Organization	Kumamoto Rehabilitation Hospital
Division name	Medical office
Address	760 Magate, Kikuyo-town, Kikuchi-county, Kumamoto prefecture
TEL	0962323111
Email	hanley.belfus@gmail.com

Public contact
Name of contact person	Yoshihiro Yoshimura
Organization	Kumamoto Rehabilitation Hospital
Division name	Medical office
Address	760 Magate, Kikuyo-town, Kikuchi-county, Kumamoto prefecture
TEL	0962323111
Homepage URL
Email	hanley.belfus@gmail.com

Sponsor
Institute	Kumamoto Rehabilitation Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Ajinomoto Co., Inc.
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	2014 Year 09 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 01 Day
Anticipated trial start date	2014 Year 09 Month 17 Day
Last follow-up date	2015 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 07 Month 31 Day

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

Management information
Registered date	2014 Year 09 Month 15 Day
Last modified on	2017 Year 08 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017629