UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018640
Receipt number R000021567
Scientific Title The effect of Stand/Gait rehabilitation using BCAA and vitamin D high formulated nutritional supplement from the acute phase for inpatients with gait disturbance, Randomized, Open-Label, Comparative Study
Date of disclosure of the study information 2015/08/11
Last modified on 2016/09/28 22:01:23

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Basic information

Public title

The effect of Stand/Gait rehabilitation using BCAA and vitamin D high formulated nutritional supplement from the acute phase for inpatients with gait disturbance, Randomized, Open-Label, Comparative Study

Acronym

The effect of Stand/Gait rehabilitation using BCAA and vitamin D high formulated nutritional supplement

Scientific Title

The effect of Stand/Gait rehabilitation using BCAA and vitamin D high formulated nutritional supplement from the acute phase for inpatients with gait disturbance, Randomized, Open-Label, Comparative Study

Scientific Title:Acronym

The effect of Stand/Gait rehabilitation using BCAA and vitamin D high formulated nutritional supplement

Region

Japan


Condition

Condition

Hospitalized patient with gait disturbance

Classification by specialty

Geriatrics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effects of Stand/Gait Training using BCAA and vitamin D high formulated nutritional supplement from the acute phase for inpatients with gait disturbance on ADL, physical activity, skeletal muscle mass and muscle strength.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

Motor FIM gain
Assessment in baseline and every month

Key secondary outcomes

1.Muscle mass (measured by the InBody S10 every 2 weeks)
2.Muscle strength (mesured by the dynamometer)
3.Swallowing function (FILS, tongue pressure)
4.Cognitive function(HDS-R, FIM)
5.Nutritional assessment(MNA-SF, BMI, Alb, Lymphocyte Count)
6.Gait function (Timed up & go test, 6 minutes-walk test , gait speed )
2-6:Assessment in baseline and every month


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Stand/Gait training with BCAA and vitamin D high formulated nutritional supplement
1.Jelly type nutritional supplement 2 bags per day
BCAA 2500 mg, vit.D 800iu per one bag of the nutritional supplement
It starts within two weeks from hospitalization
It continues until discharge
2.Stand/Gait training with therapist

Interventions/Control_2

Stand/Gait training without BCAA and vitamin D high formulated nutritional supplement
1.Stand/Gait training with therapist

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

1.FIM score of locomotion is less than 5 or 6 whose gait speed is less than 0.8m/s
2.Stand/Gait training in physical therapy
3.Able to intervene in continuously from the acute phase ward to the recovery phase rehabilitation ward
4.Patient with more than 70% of dietary intake
5.Agreement to participate in the research.

Key exclusion criteria

1.Cow's milk allergy, soybean allergy, citrus fruit allergy
2.Severe renal dysfunction (GFR<30)
3.Patients who cannot take in jelly at all

Target sample size

78


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Misa Moriwaki

Organization

Midorigaoka Hospital

Division name

Department of Rehabilitation, medical office

Zip code


Address

3-13-1Makami-cho,Takatsuki-city,Osaka prefecture

TEL

027-681-5975

Email

reha-1@midorigaoka.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Misa Moriwaki

Organization

Midorigaoka Hospital

Division name

Department of Rehabilitation, medical office

Zip code


Address

3-13-1Makami-cho,Takatsuki-city,Osaka prefecture

TEL

027-681-5975

Homepage URL


Email

reha-1@midorigaoka.or.jp


Sponsor or person

Institute

Midorigaoka 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


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

社会医療法人祐生会 みどりヶ丘病院(大阪府)


Other administrative information

Date of disclosure of the study information

2015 Year 08 Month 11 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

2015 Year 08 Month 07 Day

Date of IRB


Anticipated trial start date

2015 Year 08 Month 13 Day

Last follow-up date

2016 Year 07 Month 10 Day

Date of closure to data entry

2016 Year 07 Month 10 Day

Date trial data considered complete

2016 Year 07 Month 10 Day

Date analysis concluded

2016 Year 09 Month 28 Day


Other

Other related information



Management information

Registered date

2015 Year 08 Month 11 Day

Last modified on

2016 Year 09 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021567


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name