UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030462
Receipt number R000034782
Scientific Title Whole body vibration for patients with nonalcoholic fatty liver disease
Date of disclosure of the study information 2017/12/19
Last modified on 2017/12/19 12:12:20

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Basic information

Public title

Whole body vibration for patients with nonalcoholic fatty liver disease

Acronym

Whole body vibration for patients with NAFLD

Scientific Title

Whole body vibration for patients with nonalcoholic fatty liver disease

Scientific Title:Acronym

Whole body vibration for patients with NAFLD

Region

Japan


Condition

Condition

patients with nonalcoholic fatty liver disease

Classification by specialty

Gastroenterology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effectiveness and usefulness of whole body vibration in management of patients with nonalcoholic fatty liver disease

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Hepatic fat content and stiffness

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients with NAFLD who undergo the whole body vibration exercise regimen

Interventions/Control_2

Patients with NAFLD who did not undergo the exercise regimen

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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Sedentary (<=1 session per week and <=30 min per session)
2) Subjects with non alcoholic fatty liver disease

Key exclusion criteria

1) Subjects without serious major heart problems
2) Subjects who can not take written informed consent
3) Subjects determined to be inappropriate by physician
4) Subjects who did not receive allocated intervention

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Junichi Shoda

Organization

University of Tsukuba

Division name

Faculty of Medicine

Zip code


Address

1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan

TEL

+81-29-853-3291

Email

shodaj@md.tsukuba.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Junichi Shoda

Organization

University of Tsukuba

Division name

Faculty of Medicine

Zip code


Address

1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan

TEL

+81-29-853-3291

Homepage URL


Email

shodaj@md.tsukuba.ac.jp


Sponsor or person

Institute

University of Tsukuba

Institute

Department

Personal name



Funding Source

Organization

Grants-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science and Technology, Japan

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

2017 Year 12 Month 19 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

2012 Year 01 Month 10 Day

Date of IRB


Anticipated trial start date

2014 Year 04 Month 01 Day

Last follow-up date

2017 Year 03 Month 20 Day

Date of closure to data entry

2017 Year 04 Month 01 Day

Date trial data considered complete

2017 Year 05 Month 01 Day

Date analysis concluded

2017 Year 10 Month 01 Day


Other

Other related information



Management information

Registered date

2017 Year 12 Month 19 Day

Last modified on

2017 Year 12 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034782


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name