UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039013 |
|---|---|
| Receipt number | R000044238 |
| Scientific Title | Effects of neuromuscular electrical stimulation on prevention of ICU-acquired weakness. |
| Date of disclosure of the study information | 2020/01/01 |
| Last modified on | 2022/12/29 09:44:20 |
* 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
Effects of neuromuscular electrical stimulation on prevention of ICU-acquired weakness.
Acronym
Effects of neuromuscular electrical stimulation on prevention of ICU-acquired weakness.
Scientific Title
Effects of neuromuscular electrical stimulation on prevention of ICU-acquired weakness.
Scientific Title:Acronym
Effects of neuromuscular electrical stimulation on prevention of ICU-acquired weakness.
Region
| Japan |
Condition
Condition
ICU-acquired weakness
Classification by specialty
| Emergency medicine | Intensive care medicine | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of neuromuscular electrical stimulation for preventing ICU-acquired weakness in mechanically ventilated patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Daily neuromuscular electrical stimulation knee extension torque
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
For the NMES group,
Patients starts NMES therapy to bilateral knee extension muscles (5min/day, 50Hz, input<100mA, pulse amplitude 600 micro sec, 2 sec on-4sec off in 48 hours after admitting to ICU,
Interventions continue everyday while patients use ventilator On the first day and the final day in intervention,
Interventions/Control_2
For plasebo group
No electronic stimulation therapy
On the first day and final day of intervention, in placebo group
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 can start NMES therapy in 48hr after admitting to ICU, and continue it more than 2 days
Key exclusion criteria
under 18 years old, pregnant, BMI over 35, neuromuscular disease patients, Patients who have PM, clinical brain-dead patients, those who can't put electrode on their thigh, etc
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | eichi |
| Middle name | |
| Last name | narimatsu |
Organization
Sapporo medical university
Division name
Emergency Medicine
Zip code
0608543
Address
291 S1W16 Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
enarimat@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | yoichi |
| Middle name | |
| Last name | katayama |
Organization
Sapporo medical university
Division name
Emergency Medicine
Zip code
0608543
Address
291 S1W16 Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
Homepage URL
https://web.sapmed.ac.jp/tccm/index.html
yoichikata@gmail.com
Sponsor or person
Institute
Sapporo medical university
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Sapporo medical university
Address
291 S1W16 Chuo-ku, Sapporo, Hokkaido, Japan
Tel
011-611-2111
ji-rskk@sapmed.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
札幌医科大学附属病院救命救急センター
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 27 | Day |
Last modified on
| 2022 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044238
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
