UMIN-CTR Clinical Trial

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

Neuropathy

Classification by specialty

Medicine in general	Neurology	Orthopedics

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

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

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

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

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

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

Institute

Yamaguchi University

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and Technology, Japan.

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Kyushu Nutrition Welfare University

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

09

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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