UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031018 |
|---|---|
| Receipt number | R000035408 |
| Scientific Title | Safety and Feasibility study of Leg Exercise Apparatus (LEX) for prophylaxis of deep vein thrombosis for bedridden patients |
| Date of disclosure of the study information | 2018/01/26 |
| Last modified on | 2025/03/03 21:24:32 |
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Basic information
Public title
Safety and Feasibility study of Leg Exercise Apparatus (LEX) for prophylaxis of deep vein thrombosis for bedridden patients
Acronym
Safety and Feasibility study of Leg Exercise Apparatus (LEX) for prophylaxis of deep vein thrombosis
Scientific Title
Safety and Feasibility study of Leg Exercise Apparatus (LEX) for prophylaxis of deep vein thrombosis for bedridden patients
Scientific Title:Acronym
Safety and Feasibility study of Leg Exercise Apparatus (LEX) for prophylaxis of deep vein thrombosis
Region
| Japan |
Condition
Condition
bedridden patients
Classification by specialty
| Cardiology | Orthopedics | Cardiovascular surgery |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of feasibility and safety of Leg
Exercise Apparatus (LEX)
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
adverse event
failure of LEX
feasibility of LEX exercise
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
Do exercise using LEX
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients requiring bed rest
Key exclusion criteria
1. patients with proximal deep vein thrombosis
2. patients with aneurysms in brain or aorta
3. patients unstable in general condition
4. patients with unstable high blood pressure
5. pregnant patients or suspected pregnancy
6. patients who cannot do ankle active exercise
7. patients who cannot consent in writing
8. patients whom doctor judge as inadequacy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukiyo Shimizu |
Organization
University of Tsukuba Hospital
Division name
Department of Rehabilitation Medicine
Zip code
Address
2-1-1, Amakubo, Tsukuba, Ibaraki, Japan
TEL
029-853-3219
shimiyukig@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukiyo Shimizu |
Organization
University of Tsukuba Hospital
Division name
Department of Rehabilitation Medicine
Zip code
Address
2-1-1, Amakubo, Tsukuba, Ibaraki, Japan
TEL
029-853-3219
Homepage URL
shimiyukig@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba Hospital
Institute
Department
Personal name
Funding Source
Organization
Ibaraki
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
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
| 2018 | Year | 01 | Month | 26 | Day |
Related information
URL releasing protocol
https://rctportal.niph.go.jp/s/detail/um?trial_id=UMIN000031018
Publication of results
Published
Result
URL related to results and publications
https://www.cureus.com/articles/74668-safety-of-venous-thromboembolism-prophylaxis-protocol-using-a-
Number of participants that the trial has enrolled
31
Results
The Leg Exercise Apparatus (LEX) was used in 31 bedridden patients with spinal diseases to prevent venous thromboembolism (VTE). Patients performed LEX exercises three times a day for five minutes per session. Twenty-nine patients continued the exercises until they were able to leave the bed. No new cases of VTE were observed.
Results date posted
| 2025 | Year | 03 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of thirty-one participants (11 men, 20 women) with a mean age of 72.4 years. The majority had spinal fractures (twenty-four patients).
Participant flow
Thirty-one patients were enrolled; twenty-nine continued LEX training until leaving bed, while two dropped out due to worsening medical conditions.
Adverse events
No symptomatic VTE or severe adverse events were observed.
Outcome measures
Evaluated VTE incidence, adverse events, vital signs, and blood tests (D-dimer levels).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 26 | Day |
Last modified on
| 2025 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035408
