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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042154
Receipt No. R000048102
Scientific Title Effect of neuromuscular electrical stimulation for elderly critical ill patients in Intensive Care Unit:a randomized controlled trial
Date of disclosure of the study information 2020/10/19
Last modified on 2020/10/18

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Basic information
Public title Effect of neuromuscular electrical stimulation for elderly critical ill patients in Intensive Care Unit:a randomized controlled trial
Acronym Effect of neuromuscular electrical stimulation for elderly critical ill patients in Intensive Care Unit:a randomized controlled trial
Scientific Title Effect of neuromuscular electrical stimulation for elderly critical ill patients in Intensive Care Unit:a randomized controlled trial
Scientific Title:Acronym Effect of neuromuscular electrical stimulation for elderly critical ill patients in Intensive Care Unit:a randomized controlled trial
Region
Japan

Condition
Condition Elderly critical ill patients in Intensive Care Unit
Classification by specialty
Intensive care medicine Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate whether or not a neuromuscular electrical stimulation therapy in combination with an early rehabilitation is effective in improving Knee extension strength and physical function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Knee extension strength and weight ratio by Hand-Held Dynamometer
Key secondary outcomes 6 minutes walking distance
MRC scale
Barthel index

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Usually early rehabilitation program and neuromuscular electrical stimulation therapy
Frequency 20Hz, 60 minutes par day,
Conducted every day until walking 100m continuously
Interventions/Control_2 Usually early rehabilitation program
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients who are admitted to intensive care units in emergency center of Kochi health sciences center.
Patients age 65 and over with an APACHE II score of 20 or higher.
Key exclusion criteria 1. Intensive care unit admission to be less than 72 hours
2. Clinical frailty scale => 5
3. Do not attempt resuscitation
4. Patients with difficulty walking at discharge due to stroke, neuromuscular disease, or trauma
5. Malignant tumor with poor disease control
6. After implantation of a pacemaker
7. Dementia
8. Consent can not be gotten
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Kazuhiro
Middle name
Last name Yokobatake
Organization Kochi Health Sciences Center
Division name Department of Medical Technology Rehabilitation Service
Zip code 781-8555
Address 2125-1, ike, Kochi-city, Kochi, Japan
TEL 088-837-3000
Email yokoba.1008@gmail.com

Public contact
Name of contact person
1st name Kazuhiro
Middle name
Last name Yokobatake
Organization Kochi Health Sciences Center
Division name Department of Medical Technology Rehabilitation Service
Zip code 781-8555
Address 2125-1, ike, Kochi-city, Kochi, Japan
TEL 088-837-3000
Homepage URL
Email yokoba.1008@gmail.com

Sponsor
Institute Kochi Health Sciences Center
Institute
Department

Funding Source
Organization Homerion Laboratory Co.,Ltd
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 Kochi Health Sciences Center
Address 2125-1, ike, Kochi-city, Kochi, Japan
Tel 088-837-3000
Email yokoba.1008@gmail.com

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 高知医療センター

Other administrative information
Date of disclosure of the study information
2020 Year 10 Month 19 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
2020 Year 10 Month 19 Day
Date of IRB
2020 Year 07 Month 21 Day
Anticipated trial start date
2020 Year 10 Month 19 Day
Last follow-up date
2021 Year 10 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 10 Month 18 Day
Last modified on
2020 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048102

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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