UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039616 |
|---|---|
| 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 | 2024/08/31 22:10:23 |
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Basic information
Public title
Effect of vibration therapy on physical function in critically ill adults (VTICIA trial)
Acronym
Effect of vibration therapy on physical function in critically ill adults (VTICIA trial)
Scientific Title
Effect of vibration therapy on physical function in critically ill adults (VTICIA trial)
Scientific Title:Acronym
Effect of vibration therapy on physical function in critically ill adults (VTICIA trial)
Region
| Japan |
Condition
Condition
Critically ill patients
Classification by specialty
| Medicine in general | Surgery in general | Emergency medicine |
| Intensive care medicine | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate if vibration therapy improves the physical function, delirium, and mobility level of critically ill patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional Status Score for the ICU (FSS-ICU) at the discharge from the ICU
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
They are randomized to vibration therapy (BW-750, BodyGreen, Changhua county, Taiwan) added to protocolized mobilization. The therapy will be conducted for 15 minutes
Interventions/Control_2
Protocolized mobilization alone
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are expected to stay in the ICU for more than or equal to 5 days.
Key exclusion criteria
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.
Target sample size
188
Research contact person
Name of lead principal investigator
| 1st name | Nobuto |
| Middle name | |
| Last name | Nakanishi |
Organization
Tokushima university hospital
Division name
Emergency and critical care medicine
Zip code
770-8503
Address
Tokushima
TEL
088-633-9347
nobuto_nakanishi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Nobuto |
| Middle name | |
| Last name | Nakanishi |
Organization
Tokushima University Hospital
Division name
Emergency and critical care medicine
Zip code
770-8503
Address
Tokushima
TEL
088-633-9347
Homepage URL
nobuto_nakanishi@yahoo.co.jp
Sponsor or person
Institute
The university of Tokushima
Institute
Department
Personal name
Funding Source
Organization
The university of Tokushima
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokushima university hospital, clinical trial center for developmental therapeutics
Address
2-50-1, Kuramoto, Tokushima, Tokushima
Tel
0886339294
awachiken@okushima-u.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
徳島大学病院（徳島）：Tokushima university hospital
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/33653754/
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/38277179/
Number of participants that the trial has enrolled
177
Results
98 and 82 were assigned to the intervention and target groups, 3 were excluded due to hemodynamic instability or other reasons, and 96 and 81 were included. The length of stay was 4 (3-6) days and the duration of vibratory therapy was 2 (1-3) days. no significant difference was found in the overall FSS-ICU scores, but a significant difference was found for the getting up items.Fifty-two patients reported that vibration therapy was pleasant, and 5 patients reported that it was unpleasant.
Results date posted
| 2024 | Year | 08 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients 18 years of age or older who are capable of sitting in an end-sitting position with an expected stay of at least 5 days in the ICU between the date of approval by the Tokushima University Hospital Medical Research Ethics Review Committee and July 31, 2023.
Participant flow
Randomized controlled trial to be conducted at a single center at Tokushima University Hospital. A stratified substitution block method of allocation will be used. Adjustment factors for allocation will be gender and age. Patients will be randomly assigned to intervention or non-intervention group. In the intervention group, researchers will provide 15 minutes of vibration therapy once a day, repeated daily until discharge from the ICU, in addition to the usual early rehabilitation, while the non-intervention group will receive only the usual early rehabilitation.
Adverse events
There were no serious adverse events.
Outcome measures
Primary Endpoints
Functional status score for the ICU
Secondary endpoints
Highest score of IMS
Highest MRC score
Highest score on IMS
Highest score on MRC
Depth of sedation in RASS
Delirium in CAM-ICU
Constipation
Length of stay in ICU
Duration of ventilator use
Hospital discharge
Vital sign variables after initial vibration therapy
Relaxation after initial vibration therapy
Adverse events after vibration therapy
Plan to share IPD
Data are available upon reasonable request for academic, non-commercial research purpose, which will not breach patients' confidentiality.
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study is going without problem.
Management information
Registered date
| 2020 | Year | 02 | Month | 27 | Day |
Last modified on
| 2024 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045181
