UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039130 |
|---|---|
| Receipt number | R000044626 |
| Scientific Title | Effect of vibration on chronic leg edema in chair-bound older adults: Influences of different frequencies of vibration therapy on edema control |
| Date of disclosure of the study information | 2020/02/01 |
| Last modified on | 2020/07/12 10:30:43 |
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Basic information
Public title
Effect of vibration on chronic leg edema in chair-bound older adults: Influences of different frequencies of vibration therapy on edema control
Acronym
Effect of vibration on chronic leg edema in chair-bound older adults
Scientific Title
Effect of vibration on chronic leg edema in chair-bound older adults: Influences of different frequencies of vibration therapy on edema control
Scientific Title:Acronym
Effect of vibration on chronic leg edema in chair-bound older adults
Region
| Japan |
Condition
Condition
Chronic leg edema
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify influences of different frequencies of vibration therapy on edema control and develop a sustainable care method for chronic leg edema in chair-bound older adults
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pitting score
Key secondary outcomes
Leg circumference
Thickness of subcutaneous tissue
Echo brightness of subcutaneous tissue
Echo brightness of muscle
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Vibrate legs three times per a day (15 min/session) for 2 weeks
Interventions/Control_2
Vibrate legs once per a day (45 min/session) for 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
-older adults aged 65 years or older with chronic edema in their legs
-who can get consent from participants and their families
-who spend more time sitting than standing or lying during the day
-who have edema with non-pitting or pitting score greater than or equal to 2
Key exclusion criteria
-those with uncontrolled cardiovascular, kidney, liver, or thyroid diseases
-persons diagnosed with an aneurysm or thrombosis or lymph edema
-those taking diuretic medicine
-those considered unsuitable for participation by a physician or nurse
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Sugama |
Organization
Kanazawa University
Division name
Institute for Frontier Science Initiative
Zip code
9200942
Address
5-11-80 Kodatsuno, Kanazawa, Ishikawa
TEL
076-265-2555
junkosgm@mhs.mp.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Sugama |
Organization
Kanazawa University
Division name
Institute for Frontier Science Initiative
Zip code
9200942
Address
5-11-80 Kodatsuno, Kanazawa, Ishikawa
TEL
076-265-2555
Homepage URL
junkosgm@mhs.mp.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical review board of Kanazawa University
Address
13-1 Takaramachi, Kanazawa, Ishikawa
Tel
076-265-2100
t-isomu@adm.kanazawa-u.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
特別養護老人ホーム やすらぎホーム（石川県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 12 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 11 | Day |
Last modified on
| 2020 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044626
