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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018646
Receipt No. R000021587
Scientific Title Combination of neuromuscular electrical stimulation and thermotherapy to prevent ICU-acquired weakness in a septic patient
Date of disclosure of the study information 2015/08/11
Last modified on 2018/02/11

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Basic information
Public title Combination of neuromuscular electrical stimulation and thermotherapy to prevent ICU-acquired weakness in a septic patient
Acronym Neuromuscular electrical stimulation and thermotherapy in a septic patient
Scientific Title Combination of neuromuscular electrical stimulation and thermotherapy to prevent ICU-acquired weakness in a septic patient
Scientific Title:Acronym Neuromuscular electrical stimulation and thermotherapy in a septic patient
Region
Japan

Condition
Condition Septic patient
Classification by specialty
Medicine in general Intensive care medicine Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to examine the effect of muscle strength and physical function, activity of daily living when discharged hospital
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Muscle strength, physical function, activity of daily living (first intervention, discharged ICU, discharged hospital)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 intervention group: transcutaneous EMS of the bilateral quadriceps (five times a week, 30 minutes each session)
Interventions/Control_2 intervention group: transcutaneous EMS and thermotherapy of the bilateral quadriceps (five times a week, 30 minutes each session)
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The diagnosis of sepsis was defined by Intensive care physician in the ICU, fulfilled the criteria for septic shock
Key exclusion criteria 1. severe orthopedic or neurological disorders
2. unstable cardiac disease
3. weak skin
4. malignancy
5. pregnant
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatoshi Hanada
Organization Nagasaki University Hospital
Division name Department of Rehabilitation Medicine
Zip code
Address 1-7-1 Sakamoto, Nagasaki
TEL 095-819-7258
Email mstshnd@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masatoshi Hanada
Organization Nagasaki University Hospital
Division name Department of Rehabilitation Medicine
Zip code
Address 1-7-1 Sakamoto, Nagasaki
TEL 095-819-7258
Homepage URL
Email mstshnd@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University Hospital
Institute
Department

Funding Source
Organization None
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
2015 Year 08 Month 11 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 Enrolling by invitation
Date of protocol fixation
2015 Year 01 Month 05 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 08 Month 11 Day
Last modified on
2018 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021587

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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