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 2024/01/10 09:54:01

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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

Email

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


Email

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

Email

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 2023, 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

2024 Year 01 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013770


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name