UMIN-CTR Clinical Trial

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
Email	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
Email	ktakii@hosp.ncgm.go.jp

Sponsor
Institute	Center Hospital of the National Center for Global Health and Medicine
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038247