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
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
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
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
