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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017716
Receipt No. R000020522
Scientific Title Effects of vibration on chronic leg edema in elderly people who keep sitting position for a long time: A randomized controlled study
Date of disclosure of the study information 2015/07/01
Last modified on 2015/12/04

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Basic information
Public title Effects of vibration on chronic leg edema in elderly people who keep sitting position for a long time: A randomized controlled study
Acronym Effects of vibration on chronic leg edema in elderly people
Scientific Title Effects of vibration on chronic leg edema in elderly people who keep sitting position for a long time: A randomized controlled study
Scientific Title:Acronym Effects of vibration on chronic leg edema in elderly people
Region
Japan

Condition
Condition Chronic leg edema
Classification by specialty
Cardiology Dermatology Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the effectiveness of vibration on chronic leg edema in elderly people who keep sitting position for a long time.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Leg circumferences (before intervention/ after intervention/ after follow-up)
Key secondary outcomes Pitting signs/ Echo pictures/
LYMQOL (before intervention/ after intervention/ after follow-up)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 15 min. leg vibration 3 times a day
term: 2 weeks
Interventions/Control_2 15 min. leg positioning 3 times a day
term: 2 weeks
Interventions/Control_3
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria People who give their own and family's informed consent/ Subjects who keep sitting position for a long time/ Subjects with leg edema
Key exclusion criteria Subjects with vascular diseases (Thrombosis, aneurysm, arterial sclerosis, etc.)/ Subjects who are taking diuretic medicines/ Subjects with hypertension (untreated)/ Subjects who get diagnosis of Heart, kidney, and liver disease/ Subjects with leg contractures/ People who are judged by a doctor or a nurse to be unsuitable for participation in the study
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sugama Junko
Organization Kanazawa university
Division name Department of Clinical Nursing Institute of Medical, Pharmaceutical and Health Sciences
Zip code
Address 5-11-80 Kodatsuno, Kanazawa, Ishikawa, Japan
TEL 0762652555
Email junkosgm@mhs.mp.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sugama Junko
Organization Kanazawa university
Division name Department of Clinical Nursing Institute of Medical, Pharmaceutical and Health Sciences
Zip code
Address 5-11-80 Kodatsuno, Kanazawa, Ishikawa, Japan
TEL 0762652555
Homepage URL
Email junkosgm@mhs.mp.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa university
Institute
Department

Funding Source
Organization Japan Society for Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 特別養護老人ホーム やすらぎホーム(石川県)
公益社団法人石川勤労者医療協会 金沢城北病院(石川県)

Other administrative information
Date of disclosure of the study information
2015 Year 07 Month 01 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
2015 Year 05 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 01 Day
Last follow-up date
2015 Year 11 Month 13 Day
Date of closure to data entry
2015 Year 11 Month 20 Day
Date trial data considered complete
2015 Year 11 Month 30 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 05 Month 28 Day
Last modified on
2015 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020522

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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