UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051065 |
|---|---|
| Receipt number | R000058228 |
| Scientific Title | Effects of local vibration stimulation on the bodies of elderly people using general care prevention services. |
| Date of disclosure of the study information | 2023/05/16 |
| Last modified on | 2026/01/07 16:33:52 |
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Basic information
Public title
Effects of local vibration stimulation on the bodies of elderly people using general care prevention services.
Acronym
Effects of Local Vibration Stimulation on the Elderly Body
Scientific Title
Effects of local vibration stimulation on the bodies of elderly people using general care prevention services.
Scientific Title:Acronym
Effects of local vibration stimulation on the bodies of elderly people using general care prevention services.
Region
| Japan |
Condition
Condition
Elderly
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of the effects of local vibration stimulation on the bodies of elderly people using general care prevention services.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Isometric knee extensor strength
Key secondary outcomes
Body composition
Short Physical Performance Battery
Isometric knee flexor strength
Basic Check List
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
For 12 weeks, twice weekly, with the vibration function activated, participants rolled the anterior thigh region for 5 sets of 30 s, with 30 s rest between sets.
Interventions/Control_2
For 12 weeks, twice weekly, same protocol without vibration.
Interventions/Control_3
No intervention; participants maintained usual activities (assessment only).
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
| 60 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Elderly persons using general care prevention services
2.Written informed consent to participate in this study
Key exclusion criteria
cardiovascular, respiratory, abdominal, urinary, gynaecological, neurological
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Atsuya |
| Middle name | |
| Last name | Otsuka |
Organization
Health Science University
Division name
Department of Rehabilitation, Faculty of Health Sciences
Zip code
401-0302
Address
Kodachi7187, Fujikawaguchiko Town, Minamitsuru-gun, Yamanashi
TEL
0555835299
a.otsuka@kenkoudai.ac.jp
Public contact
Name of contact person
| 1st name | Atsuya |
| Middle name | |
| Last name | Otsuka |
Organization
Health Science University
Division name
Department of Rehabilitation, Faculty of Health Sciences
Zip code
401-0302
Address
Kodachi7187, Fujikawaguchiko Town, Minamitsuru-gun, Yamanashi
TEL
0555835299
Homepage URL
a.otsuka@kenkoudai.ac.jp
Sponsor or person
Institute
Health Science University
Institute
Department
Personal name
Funding Source
Organization
Health Science University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the University of Health Sciences
Address
Kodachi7187, Fujikawaguchiko Town, Minamitsuru-gun, Yamanashi
Tel
0555835299
a.otsuka@kenkoudai.ac.jp
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
| 2023 | Year | 05 | Month | 16 | 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
55
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
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 15 | Day |
Last modified on
| 2026 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058228
