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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023954
Receipt No. R000027580
Scientific Title Efficacy of nutrition management for acute stroke patients with malnutrition risk: A randomized controlled study
Date of disclosure of the study information 2016/09/06
Last modified on 2019/06/28

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Basic information
Public title Efficacy of nutrition management for acute stroke patients with malnutrition risk: A randomized controlled study
Acronym Efficacy of nutrition management for acute stroke patients with malnutrition risk: A randomized controlled study
Scientific Title Efficacy of nutrition management for acute stroke patients with malnutrition risk: A randomized controlled study
Scientific Title:Acronym Efficacy of nutrition management for acute stroke patients with malnutrition risk: A randomized controlled study
Region
Japan

Condition
Condition stroke
Classification by specialty
Neurology Neurosurgery Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate whether the nutritional management for acute stroke patients with malnutrition risk is to improve the activity of daily living at the time of recovery phase rehabilitation hospital discharge.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Functional Independence Measure
Key secondary outcomes handgrip strength, walking speed, modified Rankin Scale, Brunnstrom Stage, Arm circumference, thigh circumference, calf circumference, body weight, serum albumin, pre albumin, transferrin, RPB, length of stay, discharge rate, hospitalization costs

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Individual nutritional management
Interventions/Control_2 Normal nutritional management
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 Acute stroke patients over the age of 65.
The nutritional status were screened after 7 days in the hospital, patients with MUST (Malnutrition Universal Screening Tool) score> 2 or Albumin< 3.0g/dl were included.
Key exclusion criteria not stable, end-of-life, severe dementia, liver cirrhosis, using the albumin preparation
Target sample size 128

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshimasa Niiya
Organization Otaru General Hospital
Division name Department of Neurosurgery
Zip code
Address 1-1-1, Wakamatsu, Otaru, Hokkaido
TEL 0134-25-1211
Email tarubyo-jimu@city.otaru.lg.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ikuto Otsuki
Organization Otaru General Hospital
Division name Department of Anesthesiology
Zip code
Address 1-1-1, Wakamatsu, Otaru, Hokkaido
TEL 0134-25-1211
Homepage URL
Email mirrorname@hotmail.com

Sponsor
Institute Otaru General 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)

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

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 06 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
2016 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 06 Day
Last modified on
2019 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027580

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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