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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044626


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name