UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057633 |
|---|---|
| Receipt number | R000065846 |
| Scientific Title | Investigating the effects of different-frequency neuromuscular electrical stimulation (NMES) on physical function decline and indication criteria in patients admitted to the EICU |
| Date of disclosure of the study information | 2025/06/15 |
| Last modified on | 2025/04/16 21:46:13 |
* 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
Investigation of the optimal NMES protocol and its applicable conditions to prevent physical function decline in patients admitted to the EICU
Acronym
Preventing Weakness with NMES
Scientific Title
Investigating the effects of different-frequency neuromuscular electrical stimulation (NMES) on physical function decline and indication criteria in patients admitted to the EICU
Scientific Title:Acronym
NMES Frequency Trial in EICU
Region
| Japan |
Condition
Condition
Sepsis, Trauma, Acute Cardiovascular Disease, Acute Respiratory Failure
Classification by specialty
| Emergency medicine | Intensive care medicine | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effectiveness of neuromuscular electrical stimulation (NMES) at different frequencies (20 Hz vs 4 Hz) in preventing physical function decline in critically ill patients admitted to the EICU, and to examine its appropriate indications.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Medical Research Council (MRC) score measured at three time points: at the start of physical therapy, at EICU discharge, and at hospital discharge
Key secondary outcomes
Functional Independence Measure (FIM), Intensive Care Unit Mobility Scale (IMS), Functional Status Score for the ICU (FSS-ICU), handgrip strength, knee extension strength, calf circumference, quadriceps muscle thickness, 6-minute walk distance (6MWD), Short Physical Performance Battery (SPPB), blood biochemical markers (C-reactive protein [CRP], creatine kinase [CK], lactate, and blood glucose), duration of mechanical ventilation, length of stay in the EICU ward, and total hospital length of stay.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients admitted to the EICU who are prescribed physical therapy will receive standard rehabilitation. Eligible participants will be randomly assigned to either the Tetanic NMES group or the Sub-Tetanic NMES group. During their stay in the EICU, NMES will be administered five times per week for 20 minutes per session. The Tetanic NMES group will receive Tetanic NMES for 20 minutes per session.
Interventions/Control_2
Patients admitted to the EICU who are prescribed physical therapy will receive standard rehabilitation. Eligible participants will be randomly assigned to either the Tetanic NMES group or the Sub-Tetanic NMES group. During their stay in the EICU, NMES will be administered five times per week for 20 minutes per session. The Sub-Tetanic NMES group will receive Sub-Tetanic NMES for 20 minutes per session.
Interventions/Control_3
A historical control group matched using propensity scores will be used as the control group.
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
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients admitted to the EICU ward of this hospital
Age 18 years or older at the time of hospital admission
Patients who have been prescribed physical therapy
Key exclusion criteria
Patients who meet any of the following conditions:
Implanted with internal electronic devices such as pacemakers that may be affected by NMES electrical stimulation
Diagnosed with progressive neuromuscular diseases
Diagnosed with malignant tumors
Undergoing therapeutic hypothermia
Medically prohibited from lower limb movement by a physician
Refused to participate in the study through informed consent or public disclosure documents
Any other patients deemed inappropriate for safe participation in this study by the principal investigator or attending physician
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | HIDEYA |
| Middle name | |
| Last name | YANAMOTO |
Organization
Osaka Medical and Pharmaceutical University Hospital
Division name
Department of Rehabilitation
Zip code
569-8686
Address
2-7 Daigakucho, Takatsuki City, Osaka, Japan
TEL
072-683-1221
hideya.yanamoto@ompu.ac.jp
Public contact
Name of contact person
| 1st name | HIDEYA |
| Middle name | |
| Last name | YANAMOTO |
Organization
Osaka Medical and Pharmaceutical University Hospital
Division name
Department of Rehabilitation
Zip code
569-8686
Address
2-7 Daigakucho, Takatsuki, Osaka, Japan
TEL
072-683-1221
Homepage URL
hideya.yanamoto@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
HIDEYA YANAMOTO
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical and Pharmaceutical University Hospital
Address
2-7 Daigakucho, Takatsuki, Osaka, Japan
Tel
072-683-1221
hideya.yanamoto@ompu.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 04 | Month | 16 | Day |
Last modified on
| 2025 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065846
