![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000034062 |
Receipt No. | 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 |
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 |
|
Condition | ||||
Condition | Neuropathy | |||
Classification by specialty |
|
|||
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 |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 | ||||||
hossain@yamaguchi-u.ac.jp |
Public contact | |||||||
Name of contact person |
|
||||||
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/ | ||||||
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 | |
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 |
|
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 |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
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 |
|
||||||
Last modified on |
|
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 |