UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042154 |
|---|---|
| Receipt number | 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 | 2023/09/22 06:09:22 |
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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
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
yokoba.1008@gmail.com
Sponsor or person
Institute
Kochi Health Sciences Center
Institute
Department
Personal name
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
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
Open public recruiting
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
| 2024 | Year | 10 | Month | 19 | Day |
Date of closure to data entry
| 2024 | Year | 10 | Month | 19 | Day |
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
| 2023 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048102
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
