UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032457
Receipt number 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 11:55:33

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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 or person

Institute

Shinkohkai Murakamikinen Hospital
Department of Nutrition

Institute

Department

Personal name



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

Value
https://center6.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