Unique ID issued by UMIN | UMIN000039616 |
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Receipt number | R000045181 |
Scientific Title | Effect of vibration therapy on physical function in critically ill adults (VTICIA trial) |
Date of disclosure of the study information | 2020/04/01 |
Last modified on | 2023/08/31 09:56:55 |
Effect of vibration therapy on physical function in critically ill adults (VTICIA trial)
Effect of vibration therapy on physical function in critically ill adults (VTICIA trial)
Effect of vibration therapy on physical function in critically ill adults (VTICIA trial)
Effect of vibration therapy on physical function in critically ill adults (VTICIA trial)
Japan |
Critically ill patients
Medicine in general | Surgery in general | Emergency medicine |
Intensive care medicine | Rehabilitation medicine |
Malignancy
NO
To evaluate if vibration therapy improves the physical function, delirium, and mobility level of critically ill patients
Efficacy
Functional Status Score for the ICU (FSS-ICU) at the discharge from the ICU
Delirium, Medical research council (MRC) score, the incidence of intensive care unit-acquired weakness (ICU-AW), ICU mobility scale (IMS), ventilator and ICU free days
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
No treatment
2
Treatment
Device,equipment |
They are randomized to vibration therapy (BW-750, BodyGreen, Changhua county, Taiwan) added to protocolized mobilization. The therapy will be conducted for 15 minutes
Protocolized mobilization alone
18 | years-old | <= |
Not applicable |
Male and Female
Patients who are expected to stay in the ICU for more than or equal to 5 days.
We will exclude patients based on the consensus for early mobilization in the Japanese society of intensive care medicine (JSICM) as following: (1) no permission from the primary doctor (2) excessive agitation (RASS more than or equal to 2) (3) impaired consciousness (RASS less than or equal to 3) (4) Unstable vital sign requiring circulatory support devices such as intra-aortic balloon pump (5) sustained low blood pressure even with the use of catecholamine (6) dramatic blood pressure change after body position change (7) the risk of rupture in untreated aneurysms (8) uncontrolled pain 9) uncontrolled intracranial pressure more than or equal to 20 mmHg (10) unstable phase in head or cervical spine injury (11) unstable bone fracture (12) active bleeding (13) insufficient stabilization or length of catheters (14) insufficient staffing (15) no consent from patients or surrogates.
188
1st name | Nobuto |
Middle name | |
Last name | Nakanishi |
Tokushima university hospital
Emergency and critical care medicine
770-8503
Tokushima
088-633-9347
nobuto_nakanishi@yahoo.co.jp
1st name | Nobuto |
Middle name | |
Last name | Nakanishi |
Tokushima University Hospital
Emergency and critical care medicine
770-8503
Tokushima
088-633-9347
nobuto_nakanishi@yahoo.co.jp
The university of Tokushima
The university of Tokushima
Japanese Governmental office
Tokushima university hospital, clinical trial center for developmental therapeutics
2-50-1, Kuramoto, Tokushima, Tokushima
0886339294
awachiken@okushima-u.ac.jp
NO
徳島大学病院(徳島):Tokushima university hospital
2020 | Year | 04 | Month | 01 | Day |
Unpublished
Data are available upon reasonable request for academic, non-commercial research purpose, which will not breach patients' confidentiality.
No longer recruiting
2020 | Year | 02 | Month | 27 | Day |
2020 | Year | 06 | Month | 15 | Day |
2020 | Year | 07 | Month | 01 | Day |
2024 | Year | 12 | Month | 31 | Day |
Study is going without problem.
2020 | Year | 02 | Month | 27 | Day |
2023 | Year | 08 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045181
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