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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026830
Receipt No. 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 2018/07/16

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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
Middle name
Last name Yanagi Hisako
Organization University of Tsukuba
Division name Faculty of Medicine
Zip code
Address 1-1-1 Tennodai, Tsukuba
TEL 029-853-2971
Email hyanagi@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sayou Hirofumi
Organization University of Tsukuba
Division name Master's Program in Medical Sciences
Zip code
Address 1-1-1 Tennodai, Tsukuba
TEL 029-273-8691
Homepage URL
Email onestepatatime0805@yahoo.co.jp

Sponsor
Institute Jun Orthopedic Clinic
Kato Orthopedic Surgery
Institute
Department

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
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
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 No longer recruiting
Date of protocol fixation
2017 Year 04 Month 30 Day
Date of IRB
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
2018 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030798

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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