UMIN-CTR Clinical Trial

Basic information
Public title	Effects and feasibility of branched chain amino acid combined with exercise in convalescent patients: A crossover trial
Acronym	Effects and feasibility of branched chain amino acid combined with exercise in convalescent patients
Scientific Title	Effects and feasibility of branched chain amino acid combined with exercise in convalescent patients: A crossover trial
Scientific Title:Acronym	Effects and feasibility of branched chain amino acid combined with exercise in convalescent patients
Region	Japan

Condition
Condition	Convalescent patients after orthopadic surgery, stroke and lower limb amputee
Classification by specialty	Neurology Orthopedics Neurosurgery Plastic surgery Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Using randomized, crossover trial, This study examined the feasibility of exercise combined with branched chain amino acid supplementation to physical function.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Quadriceps muscle thickness, cross-sectional aera of the brachium: Evaluations were conducted before starting the intervention, after each 1-month supplementation period, and after the washout period.
Key secondary outcomes	Knee extensor strength Grip strength Timed Up and Go test Functional Indepndence Measure Energy consumption Energy intake

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
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	Branched amino acid supplement 3.4g(6.8g)/ 1 month
Interventions/Control_2	starch 1.2g/ 1 month
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	Convalescent patients after orthopedic surgery, stroke and lower limb amuptee. 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 Nursing and Rehabilitation sciences
Zip code	227-8518
Address	2-1-1, Fujigaoka Aoba YOKOHAMA, KANAGAWA
TEL	+810459742221
Email	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 Nursing and Rehabilitation sciences
Zip code	227-8518
Address	2-1-1, Fujigaoka Aoba YOKOHAMA, KANAGAWA
TEL	+810459742221
Homepage URL
Email	tk.ikeda@nr.showa-u.ac.jp

Sponsor
Institute	Showa University Fujigaoka Hospital
Institute
Department

Funding Source
Organization	Grant-in-Aid for Scientific Research
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
Email	f-irb@cmed.showa-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1	F2019C09
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 09 Month 03 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	2019 Year 07 Month 21 Day
Date of IRB	2019 Year 07 Month 21 Day
Anticipated trial start date	2019 Year 09 Month 15 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 05 Month 31 Day
Date trial data considered complete	2021 Year 05 Month 31 Day
Date analysis concluded	2021 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 09 Month 02 Day
Last modified on	2021 Year 09 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043195