UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026830 |
|---|---|
| Receipt number | R000030798 |
| Scientific Title | Effects of whole-body vibration on bone mineral density under the different posture in postmenopausal women. |
| Date of disclosure of the study information | 2019/03/31 |
| Last modified on | 2020/04/04 21:34:10 |
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Basic information
Public title
Effects of whole-body vibration on bone mineral density under the different posture in postmenopausal women.
Acronym
Effects of whole-body vibration on bone mineral density under the different posture in postmenopausal women.
Scientific Title
Effects of whole-body vibration on bone mineral density under the different posture in postmenopausal women.
Scientific Title:Acronym
Effects of whole-body vibration on bone mineral density under the different posture in postmenopausal women.
Region
| Japan |
Condition
Condition
Postmenopausal women
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of whole body vibration on bone density under the different posture in postmenopausal women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bone density of the lumbar and femoral neck
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
3 times a week, 10 minutes, 1 year
Interventions/Control_2
3 times a week, 10 minutes, 1 year
Interventions/Control_3
3 times a week, 10 minutes, 1 year
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
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
1.YAM value of lumbar spine and femoral neck bone density is 70% or more
2.Not taken drugs for osteoporosis
Key exclusion criteria
1.Diseases or medication affecting bone metabolism
2.Diseases or medication affecting neuromuscular performance
3.Implants of the both lower extremity or spine
4.Low physical capacity
Target sample size
124
Research contact person
Name of lead principal investigator
| 1st name | Hisako |
| Middle name | |
| Last name | Yanagi |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
305-8577
Address
1-1-1 Tennodai, Tsukuba
TEL
029-853-2971
hyanagi@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Hirofumi |
| Middle name | |
| Last name | Sayou |
Organization
University of Tsukuba
Division name
Master's Program in Medical Sciences
Zip code
305-8577
Address
1-1-1 Tennodai, Tsukuba
TEL
029-273-8691
Homepage URL
onestepatatime0805@yahoo.co.jp
Sponsor or person
Institute
Jun Orthopedic Clinic
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
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
tukuba clinical research & development organization
Address
2-1-1 Tennodai, Tsukuba
Tel
0298533914
t-credo.adm@un.tukuba.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
| 2019 | Year | 03 | Month | 31 | 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
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 02 | Day |
Last modified on
| 2020 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030798
