UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023954 |
|---|---|
| Receipt number | 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 11:52:38 |
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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
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
mirrorname@hotmail.com
Sponsor or person
Institute
Otaru General 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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027580
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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