UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034062
Receipt number R000038822
Scientific Title Changes in sensation and peripheral circulation due to controlled systemic vibration exposure in the elderly: randomized controlled trials
Date of disclosure of the study information 2018/09/07
Last modified on 2018/09/07 13:29:33

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Basic information

Public title

Changes in sensation and peripheral circulation due to controlled systemic vibration exposure in the elderly: randomized controlled trials

Acronym

Changes in sensation and peripheral circulation due to controlled systemic vibration exposure in the elderly: randomized controlled trials

Scientific Title

Changes in sensation and peripheral circulation due to controlled systemic vibration exposure in the elderly: randomized controlled trials

Scientific Title:Acronym

Changes in sensation and peripheral circulation due to controlled systemic vibration exposure in the elderly: randomized controlled trials

Region

Japan


Condition

Condition

Neuropathy

Classification by specialty

Medicine in general Neurology Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We reveal that vibration exposure improves peripheral circulation without changing heart rate and blood pressure.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Increase in skin blood flow rate after 5 times vibration test

Key secondary outcomes

Heart rate variability(HRV), Blood pressure( BP), Vibrotactile perception threshold(VPT), Thermotactile perception threshold(TPT), Timed Up-and-Go(TUG), Parallel Walk Test(PWT), Single leg stance test(SLS) and Sit To Stand Test(SST)


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Subjects are asked to perform whole body vibration at 15 Hz.
Vibration amplitude is 4 mm, loading for 1 minute three times, with a 1 minute rest between.

Interventions/Control_2

Subjects are asked to perform whole body vibration at 20 Hz.
Vibration amplitude is 4 mm, loading for 1 minute three times, with a 1 minute rest between.

Interventions/Control_3

Subjects are asked to perform whole body vibration at 25 Hz.
Vibration amplitude is 4 mm, loading for 1 minute three times, with a 1 minute rest between.

Interventions/Control_4

Subjects are not asked to perform whole body vibration.

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

1) Persons who are 65 years of age or older at the time of consent acquisition (Upper limits of age are not specifically provided).
2) After receiving sufficient explanation for the participation of this research, those who obtained document consent by their own free will with sufficient understanding.

Key exclusion criteria

1) Currently, those who are exposed to occupational vibration exposure.
2) Participants of exercise program of moderate intensity over 2 hours per week.
3) A person who is taking a disease or medication (diabetes, neuromyopathy or neurodegenerative disease, musculoskeletal disorder, stroke, collagen disease, etc.) known to affect peripheral circulation.
4) Persons who have artifacts in the body that may be harmful by giving vibration (implants, stents, pacemakers, artificial joints, etc. inside the body).
5) Persons who may be particularly harmful in affecting peripheral circulation (serious heart disease etc.).
6) Persons with cognitive impairment affecting the test and training procedure (dementia etc.).

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hossain Mahbub

Organization

Yamaguchi University Graduate School of Medicine

Division name

Public Health and Preventive Medicine

Zip code


Address

Minamikogushi 1-1-1, Ube, Yamaguchi, Japan

TEL

0836-22-2231

Email

hossain@yamaguchi-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Sumie Fujimoto

Organization

Yamaguchi University Graduate School of Medicine

Division name

Public Health and Preventive Medicine

Zip code


Address

Minamikogushi 1-1-1, Ube, Yamaguchi, Japan

TEL

0836-22-2231

Homepage URL

http://dphpm.med.yamaguchi-u.ac.jp/

Email

kouei@yamaguchi-u.ac.jp


Sponsor or person

Institute

Yamaguchi University

Institute

Department

Personal name



Funding Source

Organization

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

Kyushu Nutrition Welfare University

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 09 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

Preinitiation

Date of protocol fixation

2018 Year 07 Month 23 Day

Date of IRB


Anticipated trial start date

2018 Year 09 Month 10 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

2018 Year 09 Month 07 Day

Last modified on

2018 Year 09 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038822


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name