UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000015854
Receipt No. R000018450
Scientific Title Comparison of the efficacy of branched chain amino acid with maltodextrin in outpatient rehabilitation for elderly adults with disabilities: Cross-over trial
Date of disclosure of the study information 2014/12/04
Last modified on 2020/07/13 (Ver. 7)

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Basic information
Public title Comparison of the efficacy of branched chain amino acid with maltodextrin in outpatient rehabilitation for elderly adults with disabilities: Cross-over trial
Acronym Comparison of the efficacy of amino acid with dextrin in outpatient rehabilitation for elderly adults
Scientific Title Comparison of the efficacy of branched chain amino acid with maltodextrin in outpatient rehabilitation for elderly adults with disabilities: Cross-over trial
Scientific Title:Acronym Comparison of the efficacy of amino acid with dextrin in outpatient rehabilitation for elderly adults
Region
Japan

Condition
Condition Elderly adults with disabilities
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Using cross-over trial, This study examined the efficacy of one or two session a week of exercise combined with branched chain amino acid supplementation to physical function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Upper and lower limb isometric strength(Leg press, abduction, knee extension, Rowing)
Key secondary outcomes Physical activity
(Frenchay activities index)
Grip strength
Performance test
(Timed up and go test, Functional reach test)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Dose comparison
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Branched amino acid supplement
6g/ 3 months
Washout period/ 1 month
Maltodextrin 6g/ 3 months
Interventions/Control_2 Maltodextrin 6g/ 3 months
Washout period/ 1 month
Branched amino acid supplement
6g/ 3 months
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Elderly adults with disabilities, Japanese who utilize Long-term Care Insurance.
2) Eligible to training with utilize of muscle training machine.
Key exclusion criteria 1)Persons with deglutition disorder
2)Persons with dementia
3)Persons with diabetes who need to insulin injections
4)Persons with progressive disorder of the nervous system and muscle
5)Persons with the depression or schizophrenic disorder
6)Persons with untreated cardiovascular disorder
7)Persons with renal disorder who need to dietary restriction
8)Persons who need to limitetion of physical activity
Target sample size 51

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Ikeda
Organization Tokyo Medical and Dental University Graduate school
Division name Department of Rehabilitation Medicine
Zip code 113-8510
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8510, Japan
TEL +81-03-3813-6111
Email tikeda-tmd@umin.ac.jp

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Ikeda
Organization Tokyo Medical and Dental University Graduate school
Division name Department of Rehabilitation Medicine
Zip code 113-8510
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8510, Japan
TEL +81-03-3813-6111
Homepage URL
Email tikeda-tmd@umin.ac.jp

Sponsor
Institute Shonan Kamakura general hospital
Institute
Department

Funding Source
Organization Japanese Physical Therapy Association
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

IRB Contact (For public release)
Organization Tokushukai Group Ethical Committee
Address 1-8-7,Koji-machi,Chiyoda-ku,Tokyo 102-0083,Japan
Tel +81-03-3263-4801
Email hisamatsu@mirai-iryo.com

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 介護老人保健施設リハビリケア湘南かまくら（神奈川）/Rehabil-Care Shonan Kamakura (health services facility for the aged)(Kanagawa, Japan)

Other administrative information
Date of disclosure of the study information
2014 Year 12 Month 04 Day

Related information
URL releasing protocol none
Publication of results Published

Result
URL related to results and publications https://doi.org/10.1139/apnm-2015-0436
Number of participants that the trial has enrolled 52
Results 
Using a crossover design, we investigated the effects of exercise therapy combined with BCAA intake on physical function improvement in frail and pre-frail elderly people requiring longterm care. Significant improvements in gross lower limb muscle strength and dynamic balance ability were achieved by combining BCAA intake and exercise therapy. Therefore, it is feasible to achieve these effects using this combined therapy.
Results date posted
2020 Year 07 Month 13 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Eligible persons were 80 frail and pre-frail elderly adults requiring
long-term care who received outpatient rehabilitation at a
health services facility for the aged.
Participant flow 
A single-blinded, randomized, crossover experimental design,with two 3-month periods of exercise with supplementation and a
1-month washout period of exercise without supplementation,
was used.
Adverse events 
none
Outcome measures 
Evaluations were conducted before starting the intervention, after each 3-month supplementation period (cycles A and B), and after the washout period. Investigators were not blind to group allocation. Investigators determined upper and lower limb isometric strength, grip strength, Timed Up and Go test (TUG) and Functional Reach Test (FRT) performance, Frenchay Activities Index(FAI), and the number of rehabilitation sessions. The following demographic data were collected from clinical records: age, sex, body mass index (BMI), comorbidity index, duration of outpatient rehabilitation, and underlying diseases (cranial nerve disease, musculoskeletal disease, and peripheral cardiovascular disease).
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 08 Month 12 Day
Date of IRB
2013 Year 08 Month 12 Day
Anticipated trial start date
2013 Year 08 Month 20 Day
Last follow-up date
2014 Year 04 Month 30 Day
Date of closure to data entry
2014 Year 05 Month 30 Day
Date trial data considered complete
2014 Year 05 Month 30 Day
Date analysis concluded
2014 Year 10 Month 31 Day

Other
Other related information none

Management information
Registered date
2014 Year 12 Month 04 Day
Last modified on
2020 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018450