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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028850
Receipt No. 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

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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
Institute Yamaguchi University Graduate School
Institute
Department

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
URL(English) https://upload.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


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