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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032457
Receipt No. R000037009
Scientific Title Nutritional intervention for hemodialysis patients with locomotive syndrome
Date of disclosure of the study information 2018/05/07
Last modified on 2019/03/30

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Basic information
Public title Nutritional intervention for hemodialysis patients with locomotive syndrome
Acronym Nutritional intervention for hemodialysis patients with locomotive syndrome
Scientific Title Nutritional intervention for hemodialysis patients with locomotive syndrome
Scientific Title:Acronym Nutritional intervention for hemodialysis patients with locomotive syndrome
Region
Japan

Condition
Condition locomotive syndrome
hemodialysis
Classification by specialty
Nephrology Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine a therapeutic effect of nutritional supplements on locomotive syndrome.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Physical component summary of SF-36
Key secondary outcomes Mental component summary and Role/Social component summary of SF-36, Prevalence of locootive syndrome, Skeletal muscle mass indexs,Nutritional status

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification YES
Dynamic allocation
Institution consideration
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food Behavior,custom
Interventions/Control_1 Control group is locotore 1(stand on one foot with each foot) and locotore 2(squat, 5 times, 3 sets) more than 4 times a week. It carrry out for three months.
Interventions/Control_2 Intervention group is to consume nutritional supplements once a day in addition to loco tray. It carrry out for three months.
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 Out patients with hemodialysis
Dialysis vintage one year or more
Key exclusion criteria Absolute contraindication
Acute myocardial infarction within 2 days
Unstable angina
Arrhymia
Arotic stenosis
Symptomatic heart failure
Acute myocarditis or acute pericarditis
Acute pulmonary embolism or acute pulmonary infarct
Arotic dissection
Difficult communication due to mental illness

Relative contraindication
Stenosis of the left coronary artery main pipe section
Moderate stenosis of valve
Electrolyte abnormalities
Severe hypertension
Tachyarrthymia or bradyarrthythmia
Hypertrophic cardiomyopathy or other
Inability to exercise test due to mental illness or physical disability
Seriously atrioventricular block
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kou Kitabayashi
Organization Shinkohkai Murakamikinen Hospital
Division name Nutrition
Zip code
Address 204-1, matsuyama, murakami-si, niigata, 958-0034, japan
TEL 0254-52-1229
Email kinen.eiyo@shinkohkai.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kou Kitabayashi
Organization Shinkohkai Murakamikinen Hospital
Division name Nutrition
Zip code
Address 204-1, matsuyama, murakami-si, niigata, 958-0034, japan
TEL 02545-52-1229
Homepage URL
Email kinen.eiyo@shinkohkai.jp

Sponsor
Institute Shinkohkai Murakamikinen Hospital
Department of Nutrition
Institute
Department

Funding Source
Organization The Kidney Foudation, Japan
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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
2018 Year 05 Month 07 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
2018 Year 05 Month 07 Day
Date of IRB
2017 Year 08 Month 02 Day
Anticipated trial start date
2018 Year 05 Month 07 Day
Last follow-up date
2019 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 02 Day
Last modified on
2019 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037009

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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