UMIN-CTR Clinical Trial

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
Email	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
Email	junkosgm@mhs.mp.kanazawa-u.ac.jp

Sponsor
Institute	Kanazawa University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044626