UMIN-CTR Clinical Trial

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
Last 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
1st 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