UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056149 |
|---|---|
| Receipt number | R000064118 |
| Scientific Title | Optimal exercise dose of neuromuscular electrical stimulation therapy for critically ill intensive care unit patients using belt electrode skeletal muscle electrical stimulation: a single-center randomized controlled trial. |
| Date of disclosure of the study information | 2024/11/13 |
| Last modified on | 2024/11/16 08:26:46 |
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Basic information
Public title
A study on optimal exercise dose for electrical stimulation therapy in critically ill intensive care unit patients.
Acronym
RCT of NMES in critically ill ICU patients
Scientific Title
Optimal exercise dose of neuromuscular electrical stimulation therapy for critically ill intensive care unit patients using belt electrode skeletal muscle electrical stimulation: a single-center randomized controlled trial.
Scientific Title:Acronym
RCT of NMES in critically ill ICU patients
Region
| Japan |
Condition
Condition
Patients aged 18 years and over expected to stay in ICU for more than 3 days
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Cardiology | Pneumology | Endocrinology and Metabolism |
| Hematology and clinical oncology | Nephrology | Clinical immunology |
| Psychosomatic Internal Medicine | Infectious disease | Geriatrics |
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Vascular surgery | Chest surgery | Endocrine surgery |
| Breast surgery | Obstetrics and Gynecology | Ophthalmology |
| Dermatology | Psychiatry | Oto-rhino-laryngology |
| Orthopedics | Urology | Radiology |
| Oral surgery | Cardiovascular surgery | Plastic surgery |
| Operative medicine | Emergency medicine | Intensive care medicine |
| Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to investigate the efficacy and safety of different durations (20 or 60 minutes) with B-SES in critically ill patients admitted to the ICU.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage change in rectus femoris muscle cross-sectional area (assessed using ultrasound echocardiography on days 1 and 7 of B-SES implementation)
Key secondary outcomes
-Muscle injury (assessed using N-TITIN/urinary Cre on days 3/5/7 of B-SES start)
-Adverse events during B-SES implementation
-Physical function at discharge (grip strength, Medical Research Council Score, 6-minute walk distance)
-ADL(Barthel Index) at discharge
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Treatment (B-SES 60 min/day) starts on the day of registration (Day 1) and is administered daily from Day 1 to Day 7.It should be done for a total of 60 minutes, with interruptions along the way.
Interventions/Control_2
Treatment (B-SES 20 min/day) starts on the day of registration (Day 1) and is administered daily from Day 1 to Day 7.It should be done for a total of 20 minutes, with interruptions along the way.
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) 18 years and over.
(2) Patients expected to stay in the ICU for more than 3 days
Key exclusion criteria
(1) Patients with unstable circulatory and respiratory status
(2) Patients with external cardiopulmonary ventilation
(3) Patients with trauma, infection, surgery, ischaemia or thrombosis of the lower limbs
(4) Patients with anuria
(5) Patients with implanted electronic devices (e.g. pacemakers)
(6) Patients who do not wish to undergo aggressive treatment
(7) Pregnant women
(8) Patients with neuromuscular diseases
(9) Patients on muscle relaxants
(10) Patients considered unsuitable.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Idei |
Organization
Yokohama City University Hospital
Division name
Intensive Care Department
Zip code
2360004
Address
3-9, Fukura, Yokohama Shi Kanazawa Ku, Kanagawa Ken, Japan
TEL
0457872800
idei.mas.bn@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Hideyuki |
| Middle name | |
| Last name | Oritsu |
Organization
Yokohama City University Hospital
Division name
Rehabilitation Department
Zip code
2360004
Address
3-9, Fukura, Yokohama Shi Kanazawa Ku, Kanagawa Ken, Japan
TEL
0457872800
Homepage URL
oritsu@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
IDEI Masafumi
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Yokohama City University Ethics Committee
Address
3-9, Fukura, Yokohama Shi Kanazawa Ku, Kanagawa Ken, Japan
Tel
0457872800
rinri@yokohama-cu.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
| 2024 | Year | 11 | Month | 13 | 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
| 2024 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 11 | Month | 13 | Day |
Last modified on
| 2024 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064118
