UMIN-CTR Clinical Trial

Basic information
Public title	Effect of neuromuscular electrical stimulation in patients with sepsis
Acronym	Neuromuscular electrical stimulation in patients with sepsis
Scientific Title	Effect of neuromuscular electrical stimulation in patients with sepsis
Scientific Title:Acronym	Neuromuscular electrical stimulation in patients with sepsis
Region	Japan

Condition
Condition	Sepsis
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of neuromuscular electrical stimulation in patients with sepsis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Main outcome is the mobility ability. The measurement is performed at ICU admission and discharge, and before hospital discharge. Difference in the mobility ability between patients with neuromuscular electrical stimulation and those without historical control.
Key secondary outcomes	Secondary outcome is the muscle strength and activity of daily living. The measurement is performed at ICU admission and discharge, and before hospital discharge. Difference in the muscle strength and activity of daily living between patients with neuromuscular electrical stimulation and those without historical control.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Muscle strength training with neuromuscular electrical stimulation is performed for 60-min each day, 5-days per week, from the patients or proxies agreement to hospital discharge.
Interventions/Control_2
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. Patients with sepsis in admission to medical intensive care unit at our single hospital. 2. Patients were followed in rehabilitation 3. Participants or proxies agreed to join this research.
Key exclusion criteria	1. Unable to walk without assistance before ICU admission 2. Neuromuscular disease (e.g. myasthenia Gravis, Guillain-Barre disease) 3. Muscle inflammation (e.g. rhabdomyolysis, myositis, neuroleptic malignant syndrome) 4. Skin lesions (e.g. burns) 5. Patients who were determined inappropriate to rehabilitation because of declining clinical status. 6. Patients who were determined inappropriate to participate in this study by attending physician.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Miho Shimizu
Organization	Nagoya University Hospital
Division name	Department of Rehabilitation
Zip code
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	052-741-2111
Email	miho.shimizu@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hiroki Nakajima
Organization	Nagoya University Hospital
Division name	Department of Rehabilitation
Zip code
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	052-741-2111
Homepage URL
Email	nkjmx1121@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Hospital
Institute
Department

Funding Source
Organization	Japanese Physical Therapy Association
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	名古屋大学医学部附属病院（愛知県）

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 01 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	Completed
Date of protocol fixation	2017 Year 08 Month 28 Day
Date of IRB	2017 Year 11 Month 28 Day
Anticipated trial start date	2017 Year 10 Month 01 Day
Last follow-up date	2020 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 08 Month 28 Day
Last modified on	2020 Year 02 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032808