UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028850
Receipt number R000033019
Scientific Title Evaluation of blood flow and patients' comfort following passive ankle mobilization in the prevention of deep vein thrombosis,compared with an intermittent pneumatic compression(IPC)device
Date of disclosure of the study information 2017/09/01
Last modified on 2019/02/28 21:31:38

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Basic information

Public title

Evaluation of blood flow and patients' comfort following passive ankle mobilization in the prevention of deep vein thrombosis,compared with an intermittent pneumatic compression(IPC)device

Acronym

Evaluation of blood flow and patients' comfort following passive ankle mobilization in the prevention of deep vein thrombosis,compared with an intermittent pneumatic compression(IPC)device

Scientific Title

Evaluation of blood flow and patients' comfort following passive ankle mobilization in the prevention of deep vein thrombosis,compared with an intermittent pneumatic compression(IPC)device

Scientific Title:Acronym

Evaluation of blood flow and patients' comfort following passive ankle mobilization in the prevention of deep vein thrombosis,compared with an intermittent pneumatic compression(IPC)device

Region

Japan


Condition

Condition

Healty person

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose is to assess the blood flow and the patients' comfort in the different prevention methods of DVT.The intervention of passive ankle mobilization,which is potential therapy to improve blood flow,was performed in addition to the intermittent pneumatic compression.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The primary outcome is the blood velocity of femoral vein measured at 0,15,45,50,60,75minutes in the examination.

Key secondary outcomes

Secondary outcome includes oxygenated hemoglobin measured by near-infrared spectrometer,deoxygenated hemoglobin,total hemoglobin,heart rate variability.The blood examination of coagulation and fibrinolytic activity and the subjective comfort assessment with visual analogue scale(VAS) are collected before and after each intervention.


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

In the group 1,the IPC is performed continuously for 75 minutes.

Interventions/Control_2

In the group 2,the IPC is performed for 15 minutes,followed by the break for 60 minutes with the intervention of the passive ankle mobilization at the middle of the break.

Interventions/Control_3

In the group 3,the IPC is performed for 15 minutes,followed by the break for 60 minutes.

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

20 years-old <=

Age-upper limit

40 years-old >

Gender

Female

Key inclusion criteria

Female(age:20 years old and more,less than 40 years old).

Key exclusion criteria

The person with BMI>25,estrogen treatment,varicose vein,and venous thrombosis are excluded.

Target sample size

26


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Maya Aoki

Organization

Yamaguchi University Graduate School of Medicine

Division name

Faculty of Health Science

Zip code


Address

1-1-1 Minami Kogushi,Ube, Yamaguchi

TEL

0836-22-2808

Email

mayaa@yamaguchi-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Maya Aoki

Organization

Yamaguchi University Graduate School of Medicine

Division name

Faculty of Health Science

Zip code


Address

1-1-1 Minami Kogushi,Ube, Yamaguchi

TEL

0836-22-2808

Homepage URL


Email

mayaa@yamaguchi-u.ac.jp


Sponsor or person

Institute

Yamaguchi University Graduate School

Institute

Department

Personal name



Funding Source

Organization

Grants-in-aid of the NAKANISHI MUTSUKO NURSUING PRACTICE RESEARCH FUND

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2017 Year 09 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

2017 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2017 Year 09 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 08 Month 28 Day

Last modified on

2019 Year 02 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033019


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name