UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019589 |
|---|---|
| Receipt number | R000022615 |
| Scientific Title | A randomized trial to evaluate the efficacy of Branched-Chain Amino Acid fortified supplements in post-stroke rehabilitation patients. |
| Date of disclosure of the study information | 2015/11/01 |
| Last modified on | 2016/11/08 13:48:04 |
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Basic information
Public title
A randomized trial to evaluate the efficacy of Branched-Chain Amino Acid fortified supplements in post-stroke rehabilitation patients.
Acronym
A randomized trial to evaluate the efficacy of Branched-Chain Amino Acid fortified supplements in post-stroke rehabilitation patients.
Scientific Title
A randomized trial to evaluate the efficacy of Branched-Chain Amino Acid fortified supplements in post-stroke rehabilitation patients.
Scientific Title:Acronym
A randomized trial to evaluate the efficacy of Branched-Chain Amino Acid fortified supplements in post-stroke rehabilitation patients.
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of Branched-Chain Amino Acid fortified supplements on improvement of activities of daily living in post-stroke rehabilitation patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Activities of daily living
Assessment in baseline and three months after treatment
Key secondary outcomes
1. Skeletal muscle mass (by body composition analysis)
2. Muscle strength (hand grip)
3. Swallowing ability (tongue pressure, eating and swallowing status)
4.Nutritional status
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.Branched-Chain Amino Acid fortified supplements
Jelly type supplements 1bag per day(BCAA2500mg)
Three month intervention
2.Rehabilitation
Interventions/Control_2
1.Rehabilitation
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
1.Stroke patients aged 65 or older
2.Appropriate nutritional management
3.Patients who can stand with or without assistance
Key exclusion criteria
1. Decreased level of consciousness
2. Severe dysphagia
3. Severe renal dysfunction
4. Obesity
5. Patients who are judged inappropriate for the study by the physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Rei Fujii |
Organization
Yamaguchi Rehabilitation Hospital
Division name
Rehabilitation center
Zip code
Address
3380Kurokawa,Yamaguchi-city,Yamaguchi prefecture
TEL
0839211616
rei.suzu.rin@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rei Fujiii |
Organization
Yamaguchi Rehabilitation Hospital
Division name
Rehabilitation center
Zip code
Address
3380Kurokawa,Yamaguchi-city,Yamaguchi prefecture
TEL
0839211616
Homepage URL
rei.suzu.rin@gmail.com
Sponsor or person
Institute
Yamaguchi 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
1.Clinico Co., Ltd.
2.Kumamoto Rehabilitation Hospital Department of Rehabilitation
Yoshihiro Yoshimura
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
山口リハビリテーション病院（山口県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 31 | Day |
Last modified on
| 2016 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022615
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
