UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036239 |
|---|---|
| Receipt number | R000041279 |
| Scientific Title | Effect of the time of administration of branched chain amino acid combined with exercise therapy on stroke patients |
| Date of disclosure of the study information | 2019/03/18 |
| Last modified on | 2021/09/02 17:45:29 |
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Basic information
Public title
Effect of the time of administration of branched chain amino acid combined with exercise therapy on stroke patients
Acronym
Effect of the time of administration of BCAA combined with exercise therapy on stroke patients
Scientific Title
Effect of the time of administration of branched chain amino acid combined with exercise therapy on stroke patients
Scientific Title:Acronym
Effect of the time of administration of BCAA combined with exercise therapy on stroke patients
Region
| Japan |
Condition
Condition
Brain stroke
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using randomized control trial, this study examined the influence of the time of administration of branched chain amino acid on physical function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Skeletal muscle mass
Key secondary outcomes
gloss lower limb muscle strength:Leg press
grip strength on healthy side
Brunnstrom Recovery Stage
Berg Balance Scale
Timed Up & Go Test
energy consumption
energy intake
energy balance
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
To administrate in morning for 2-months
leucine rich nutritional supplement:200kcal
BCAA3.5g(leucin 1.57g, isoleucine 0.91g, valine 1.07g)
Vitamin D: 40 IU
Whey protein: 6.5g
Interventions/Control_2
To administrate after exercise therapy in afternoon for 2-months
leucine rich nutritional supplement: 200kcal
BCAA3.5g(leucin 1.57g, isoleucine 0.91g, valine 1.07g)
Vitamin D: 40 IU
Whey protein: 6.5g
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Stroke patient who is 20 years old or over
Patients with no deglutition disorder
Key exclusion criteria
1) Persons with renal disorder who need to
protein restriction (eGFR <60)
2) Patients using BCAA formulation for
metabolic liver dysfunction and cirrhosis
3) Patients with dementia
4) Patients with the depression or
schizophrenic disorder
5) Patients with untreated cardio-vascular
disorder
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Ikeda |
Organization
Showa University
Division name
School of Nrsing and Rehabilitation sciences
Zip code
227-8518
Address
2-1-1, Fujigaoka Aoba YOKOHAMA, KANA GAWA
TEL
+81-045-974-2221
tk.ikeda@nr.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Ikeda |
Organization
Showa University
Division name
School of Nrsing and Rehabilitation sciences
Zip code
227-8518
Address
2-1-1, Fujigaoka Aoba YOKOHAMA, KANAGAWA
TEL
+81-045-974-2221
Homepage URL
tk.ikeda@nr.showa-u.ac.jp
Sponsor or person
Institute
Showa University Fujigaoka Hospital
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI grants (Grant-in-Aid for Early-Career Scientists, grant number JP 19K20159).
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University Fujigaoka Hospital Ethics Committee
Address
1-1-1, Fujigaoka Aoba YOKOHAMA, KANAGAWA
Tel
+81 045-974-2221
tk.ikeda@nr.showa-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
F2018C74
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
昭和大学藤が丘リハビリテーション病院: Showa University Fujigaoka Rehabilitation Hospital
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
DOI: 10.3390/nu12071928
Number of participants that the trial has enrolled
46
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 06 | Month | 29 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 06 | Month | 07 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 07 | Day |
Date analysis concluded
| 2020 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 18 | Day |
Last modified on
| 2021 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041279
