UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050050 |
|---|---|
| Receipt number | R000056988 |
| Scientific Title | Effect of long-term neuromuscular electrical stimulation therapy on ICU-acquired muscle weakness: a randomized, open-label, parallel-group study |
| Date of disclosure of the study information | 2023/01/16 |
| Last modified on | 2025/03/24 18:12:28 |
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Basic information
Public title
Effect of long-term neuromuscular electrical stimulation therapy on ICU-acquired muscle weakness: a randomized, open-label, parallel-group study
Acronym
Effect of long-term neuromuscular electrical stimulation therapy on ICU-acquired muscle weakness: a randomized, open-label, parallel-group study
Scientific Title
Effect of long-term neuromuscular electrical stimulation therapy on ICU-acquired muscle weakness: a randomized, open-label, parallel-group study
Scientific Title:Acronym
Effect of long-term neuromuscular electrical stimulation therapy on ICU-acquired muscle weakness: a randomized, open-label, parallel-group study
Region
| Japan |
Condition
Condition
ICU-acquired weakness (ICU-AW)
Classification by specialty
| Intensive care medicine | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of long-term neuromuscular electrical stimulation (NMES) on the recovery-promoting effects on extremity muscle strength and the ability to perform activities of daily living at discharge.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in MRC sum score (initial evaluation - 30 days after NMES start)
Key secondary outcomes
Handgrip force, quadriceps force, SPPB, BI (hospital discharge)
Change in MRC sum score (1 week, 2 weeks, 3 weeks after starting NMES)
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention group: 60 min of NMES applied to bilateral quadriceps 5 times/wk for 30 days from ICU admission
Interventions/Control_2
Control group: Same frequency and duration of bilateral quadriceps shams (ineffective stimulation intensity) for 30 days from ICU admission
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
1. Closed-ICU for more than 48 hours
2. MRC sum score < 48 (while in ICU)
3. Subjects who are awake, have received sufficient explanation about participating in this study, and have obtained written informed consent of the patient's own free will after sufficient understanding
Key exclusion criteria
1. Neuromuscular disorders in the medical history or as reason for admission
2. Orthopedic disease in the medical history or as reason for admission
3. After lung transplantation surgery
4. After artificial heart surgery
5. After implanted pacemaker
6. fragile skin
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Nagura |
Organization
Nagasaki University Hospital
Division name
Department of Rehabilitation Medicine
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki 852-8501, JAPAN
TEL
0958197258
nagura@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Nagura |
Organization
Nagasaki University Hospital
Division name
Department of Rehabilitation Medicine
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki 852-8501, JAPAN
TEL
0958197258
Homepage URL
nagura@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki 852-8501, JAPAN
Tel
0958197200
gaibushikin@ml.nagasaki-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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 16 | 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
48
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
Completed
Date of protocol fixation
| 2023 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 01 | Month | 16 | Day |
Last modified on
| 2025 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056988
