UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018646 |
|---|---|
| Receipt number | 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 | 2022/08/16 12:58:32 |
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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 | Masatoshi |
| Middle name | |
| Last name | Hanada |
Organization
Nagasaki University Hospital
Division name
Department of Rehabilitation Medicine
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki
TEL
0958197258
mstshnd@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Hanada |
| Middle name | |
| Last name | Masatoshi |
Organization
Nagasaki University Hospital
Division name
Department of Rehabilitation Medicine
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki
TEL
0958197258
Homepage URL
mstshnd@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
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
Nagasaki University Hospital
Address
Sakamoto 1-7-1, Nagasaki
Tel
0958194126
mstshnd@nagasaki-u.ac.jp
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
UMIN000018646
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished
Number of participants that the trial has enrolled
5
Results
We could not analysis.
Results date posted
| 2022 | Year | 08 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Sepsis
Participant flow
Until hospital discharge
Adverse events
None
Outcome measures
urea 3-methyl histidine
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
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
| 2022 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021587
| 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 |
