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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038344
Receipt No. R000043700
Scientific Title Effects of nutritional supplementation on nutritional status improvement in the convalescent rehabilitation ward
Date of disclosure of the study information 2019/10/21
Last modified on 2020/02/17

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Basic information
Public title Effects of nutritional supplementation on nutritional status improvement in the convalescent rehabilitation ward
Acronym Effects of nutritional supplements in the convalescent rehabilitation ward
Scientific Title Effects of nutritional supplementation on nutritional status improvement in the convalescent rehabilitation ward
Scientific Title:Acronym Effects of nutritional supplements in the convalescent rehabilitation ward
Region
Japan

Condition
Condition Orthopedic patients, bone fracture patients
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To explore the effects of nutritional supplements on nutritional status, psychosomatic function, and physical activity in patients in the convalescent rehabilitation ward
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Alb(Serum albumin)
Key secondary outcomes Basic information: body mass index (BMI), medical history, need of care, family living together, exercise habits, smoking and drinking history, falls experience
Muscle mass: Bio impedance Analysis method (BIA) using Inbody S10
Blood data: TLC, T-CHO, TP, CRP, Hb, Cre
Mini Nutritional Assessment (MNA)
International standards for undernutrition (GLIM criteria; 2018)
Kihon Check List (KCL)
Physical function: walking speed, Timed Up and Go test (TUG), One leg standing, Knee extension strength, Grip strength
Physical activity evaluation; 3-axis accelerometer Lifecoder GS (manufactured by Suzuken)
FIM (Functional Independent Measures)
Mini-Mental State Examination (MMSE)
Geriatric Depression Scale (GDS)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 In addition to usual convalescent rehabilitation and nutritional management, take 4g of nutrient (amino feel) twice a day
Interventions/Control_2
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The main disease is orthopedic disease, fracture (femoral neck fracture, lumbar compression fracture, etc.)
General condition is stable
Patients who obtained informed consent for participation in this study
Key exclusion criteria Motor paralysis and higher brain dysfunction due to cerebrovascular disease
Physically and mentally severe condition due to malignant tumors and severe dementia
Bedridden at the end of the disease
Peripheral vascular disease with intermittent claudication
Acute arthritis
Severe chronic obstructive pulmonary disease
heart failure (New York Heart Association (NYHA) stage 3 or 4)
specific myopathy
Bio impedance Analysis (BIA) contraindications (Ex. Cardiac pacemaker)
Kidney disease (CKD stage3 or higher)
Milk component allergy
Moderate or higher obesity (BMI>=30)
Uncontrolled diabetes mellitus
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Izumi
Middle name
Last name Kondo
Organization National Center for Geriatrics and Gerontology
Division name Rehabilitation Center
Zip code 474-8511
Address 7-430, Moriokacho, Obu-shi, Aichi, 474-8511, Japan
TEL 0562-46-2311
Email ik7710@ncgg.go.jp

Public contact
Name of contact person
1st name Izumi
Middle name
Last name Kondo
Organization National Center for Geriatrics and Gerontology
Division name Rehabilitation Center
Zip code 474-8511
Address 7-430, Moriokacho, Obu-shi, Aichi, 474-8511, Japan
TEL 0562-46-2311
Homepage URL
Email ik7710@ncgg.go.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
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 None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization National Center for Geriatrics and Gerontology Ethics and Conflict of Interest Committee
Address 7-430, Moriokacho, Obu-shi, Aichi, 474-8511, Japan
Tel 0562-46-2311
Email rehab@ncgg.go.jp

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 国立長寿医療研究センター(愛知県)

Other administrative information
Date of disclosure of the study information
2019 Year 10 Month 21 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
2020 Year 02 Month 17 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
none
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2019 Year 10 Month 15 Day
Date of IRB
2019 Year 10 Month 15 Day
Anticipated trial start date
2019 Year 11 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 09 Month 30 Day
Date trial data considered complete
2021 Year 09 Month 30 Day
Date analysis concluded
2022 Year 03 Month 31 Day

Other
Other related information The first case was registered on November 1, 2019, and evaluation and intervention have started.

Management information
Registered date
2019 Year 10 Month 20 Day
Last modified on
2020 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043700

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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