UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033540 |
|---|---|
| Receipt number | R000038247 |
| Scientific Title | An exploratory randomized controlled trial testing efficacy of adjunctive electrical muscle stimulation used in early rehabilitation in patients with sepsis |
| Date of disclosure of the study information | 2018/07/27 |
| Last modified on | 2019/11/27 20:16:27 |
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Basic information
Public title
An exploratory randomized controlled trial testing efficacy of adjunctive electrical muscle stimulation used in early rehabilitation in patients with sepsis
Acronym
Sepsis EMS study
Scientific Title
An exploratory randomized controlled trial testing efficacy of adjunctive electrical muscle stimulation used in early rehabilitation in patients with sepsis
Scientific Title:Acronym
Sepsis EMS study
Region
| Japan |
Condition
Condition
Sepsis
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigates whether conventional physiotherapy plus EMS prevents muscle strength impairment more than physiotherapy alone.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is decrement in quadriceps strength (N/kg) on Day 15 versus Day 1.
Key secondary outcomes
Secondary outcomes are decrements in muscle strength grade determined by the manual muscle test (MMT) and in thickness of the rectus femoris muscle on Day 1, Day 8, and Day 15. The pre-hospitalization FIM score will be recorded on the day of hospital admission, and change in the FIM score on Day 15 compared with the prehospitalization value will be assessed
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The intervention group will receive EMS as follows. Belt electrodes of the Auto Tens Pro (Homer Ion Co. Ltd., Tokyo, Japan) will be placed around the abdomen, distal part of both thighs, and both ankles so that the entire lower limbs can be electrically stimulated. Once-daily 20-min stimulation (5-s stimulations at 20 Hz at 2-s intervals) will be delivered 5 days a week for 2 weeks. The electrical current value will be in the range of 2 to 15 mA. A total of 3 days will be used to determine the maximum electrical current value with an acceptable level of discomfort for each patient. A rehabilitation physician, one of the co-investigators, will supervise the 14-day intervention. On the same days as EMS, patients will receive conventional physiotherapy, as the control group will receive.
Interventions/Control_2
The control group will be treated solely using conventional physiotherapy over 14 days. Conventional physiotherapy comprises motor exercises and range of motion exercises.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.A signed informed consent form for participation in the study provided by the patient, or if difficult, by an authorized representative who has the legal capacity to decide the therapy strategy.
2.=> 20 years old
3.Diagnosis of sepsis
Key exclusion criteria
1.Presence of a pacemaker
2.Known primary systemic neuromuscular disease or intracranial disease at admission
3.Pre-hospitalization functional independence measure (FIM) score < 80, with inability to walk independently
4.Fracture or skin lesion (except contusion) in the region subjected to EMS (thigh, knee joint, ankle joint)
5.Pregnancy
6.Assessed as approaching or imminent death
7.Trauma
8.Unable to reach consensus
9.Determined by the physician-in-charge
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Kimura |
Organization
Center Hospital of the National Center for Global Health and Medicine
Division name
Department of Emergency Medicine and Critical Care
Zip code
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan
TEL
03-3202-7181
akimura@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kento Takii |
Organization
Center Hospital of the National Center for Global Health and Medicine
Division name
Department of Emergency Medicine and Critical Care
Zip code
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan
TEL
03-3202-7181
Homepage URL
ktakii@hosp.ncgm.go.jp
Sponsor or person
Institute
Center Hospital of the National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
Center Hospital of the National Center for Global Health and Medicine
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
Address
Tel
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
| 2018 | Year | 07 | Month | 27 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | 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
| 2018 | Year | 07 | Month | 27 | Day |
Last modified on
| 2019 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038247
