UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Misa Moriwaki
Organization	Midorigaoka Hospital
Division name	Department of Rehabilitation, medical office
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	Misa Moriwaki
Organization	Midorigaoka Hospital
Division name	Department of Rehabilitation, medical office
Address	3-13-1Makami-cho,Takatsuki-city,Osaka prefecture
TEL	027-681-5975
Homepage URL
Email	reha-1@midorigaoka.or.jp

Sponsor
Institute	Midorigaoka Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021567