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Recruitment status Completed
Unique ID issued by UMIN UMIN000015158
Receipt No. R000017629
Scientific Title 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
Date of disclosure of the study information 2014/09/16
Last modified on 2017/08/28

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Basic information
Public title 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
Acronym The effect of leucine high formulated nutritional supplementation on physical function
Scientific Title 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
Scientific Title:Acronym 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

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 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

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
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
1st name
Middle name
Last name Yoshihiro Yoshimura
Organization Kumamoto Rehabilitation Hospital
Division name Medical office
Zip code
Address 760 Magate, Kikuyo-town, Kikuchi-county, Kumamoto prefecture
TEL 0962323111
Email hanley.belfus@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro Yoshimura
Organization Kumamoto Rehabilitation Hospital
Division name Medical office
Zip code
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

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 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)

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
2014 Year 09 Month 16 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 Completed
Date of protocol fixation
2014 Year 09 Month 01 Day
Date of IRB
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

Other
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


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