UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011787 |
|---|---|
| Receipt number | R000013770 |
| Scientific Title | Evaluation of lower limb blood flow and effective exercise for preventing deep vein thrombosis by using the ankle active exercise apparatus (LEX) |
| Date of disclosure of the study information | 2013/09/18 |
| Last modified on | 2025/01/13 10:25:48 |
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Basic information
Public title
Evaluation of lower limb blood flow and effective exercise for preventing deep vein thrombosis by using the ankle active exercise apparatus (LEX)
Acronym
Evaluation of lower limb blood flow and effective exercise by using LEX
Scientific Title
Evaluation of lower limb blood flow and effective exercise for preventing deep vein thrombosis by using the ankle active exercise apparatus (LEX)
Scientific Title:Acronym
Evaluation of lower limb blood flow and effective exercise by using LEX
Region
| Japan |
Condition
Condition
DVT
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation the effectiveness of LEX
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We confirm the presence of thrombus by ultrasound of the legs after using LEX to the patients who had the surgery.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
confirm the effectiveness to the healthy volunteer person
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 25 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy volunteer person
Key exclusion criteria
the person who has DVT
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | KAMADA |
Organization
University of Tsukuba
Division name
Department of Orthopaedic surgery
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba
TEL
029-853-3219
hkamada@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | KAMADA |
Organization
University of Tsukuba
Division name
Department of Orthopaedic surgery
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba
TEL
029-853-3219
Homepage URL
hkamada@md.tsukuba.ac.jp
Sponsor or person
Institute
Department of Orthopaedic surgery, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedic surgery, University of Tsukuba
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
2-1-1 Amakubo Tsukuba, JAPAN
Tel
029-853-3914
toyoshima.yuka.gn@un.tsukuba.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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 18 | 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
0
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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2013 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
As of January 2025, registrations have concluded, and we are in the final follow-up phase.
Management information
Registered date
| 2013 | Year | 09 | Month | 18 | Day |
Last modified on
| 2025 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013770
