UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027054 |
|---|---|
| Receipt number | R000031011 |
| Scientific Title | Effect of electrical muscle stimulation in critically ill patients : a randomized study |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2020/09/15 14:08:27 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of electrical muscle stimulation in critically ill patients : a randomized study
Acronym
Effect of electrical muscle stimulation in critically ill patients
Scientific Title
Effect of electrical muscle stimulation in critically ill patients : a randomized study
Scientific Title:Acronym
Effect of electrical muscle stimulation in critically ill patients
Region
| Japan |
Condition
Condition
Critically ill patients
Classification by specialty
| Intensive care medicine | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of electrical muscle stimulation for preventing upper and lower limbs atrophy of critically ill patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of the upper and lower limb muscle mass atrophy measured by ultrasonography in intensive care patients at day 1 and 5.
Key secondary outcomes
MRC score, ICU-AW, IMS, amino acid in blood, ICU and ventilator-free days, length of admission in hospital.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Electrical muscle stimulation for 30 minutes/ day until day 5 after ICU admission.
Interventions/Control_2
No electrical muscle stimulation in the ICU.
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
Adult patients who were expected to be mechanically ventilated longer than 48 hours and to stay more than 5 days in the ICU.
Key exclusion criteria
1 systolic blood pressure < 80 mmHg with catecholamine
2 heart rate < 40/min or >140/min
3 pulse oximetry < 88%
4 primary neuromuscular disease
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Nobuto |
| Middle name | |
| Last name | Nakanishi |
Organization
Tokushima University Graduate School
Division name
Emergency and Critical Care medicine
Zip code
770-8503
Address
2-50-1 Kuramoto, Tokushima, 770-8503, Japan
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 Graduate School
Division name
Emergency and Critical Care medicine
Zip code
770-8503
Address
2-50-1 Kuramoto, Tokushima, 770-8503, Japan
TEL
088-633-9347
Homepage URL
nobuto_nakanishi@yahoo.co.jp
Sponsor or person
Institute
Tokushima University Graduate School
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokushima Prefectural Central Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Trial Center for Developmental therapeutics, Tokushima University Hospital
Address
2-50-1 Kuramoto, Tokushima, 770-8503, Japan
Tel
088-633-9294
awachiken@tokushima-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、徳島県立中央病院（1740)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/32897665/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/32897665/
Number of participants that the trial has enrolled
42
Results
In 5 days, the change in biceps brachii muscle thickness was -1.9% versus -11.2% in the electrical muscle stimulation and control (p = 0.007) groups, and the change in cross-sectional area was -2.7% versus -10.0% (p = 0.03). The change in rectus femoris muscle thickness was -0.9% versus -14.7% (p = 0.003) and cross-sectional area was -1.7% versus -10.4% (p = 0.04).
Results date posted
| 2020 | Year | 05 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 09 | Month | 30 | Day |
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 15 | Day |
Date of closure to data entry
| 2020 | Year | 09 | Month | 15 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
42 patients were included.
Management information
Registered date
| 2017 | Year | 04 | Month | 18 | Day |
Last modified on
| 2020 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031011
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
