UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief 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
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	Maya Aoki
Organization	Yamaguchi University Graduate School of Medicine
Division name	Faculty of Health Science
Address	1-1-1 Minami Kogushi,Ube, Yamaguchi
TEL	0836-22-2808
Email	mayaa@yamaguchi-u.ac.jp

Public contact
Name of contact person	Maya Aoki
Organization	Yamaguchi University Graduate School of Medicine
Division name	Faculty of Health Science
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000033019