UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015158
Receipt number 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 12:53:46

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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


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

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 or person

Institute

Kumamoto Rehabilitation Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017629


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name