UMIN-CTR Clinical Trial

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
Institute	Yamaguchi University
Institute
Department

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
URL(English)	https://upload.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

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