UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037903
Receipt number R000043195
Scientific Title Effects and feasibility of branched chain amino acid combined with exercise in convalescent patients: A crossover trial
Date of disclosure of the study information 2019/09/03
Last modified on 2021/09/02 17:48:23

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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 or person

Institute

Showa University Fujigaoka Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043195


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name