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
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
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
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
