UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017716 |
|---|---|
| Receipt number | 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 22:33:44 |
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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
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
junkosgm@mhs.mp.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020522
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
