UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037274 |
|---|---|
| Receipt number | R000042461 |
| Scientific Title | Changes in muscle oxygenation status by muscle electrical stimulation for patients admitted to intensive care unit |
| Date of disclosure of the study information | 2019/07/06 |
| Last modified on | 2025/04/02 10:03:55 |
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Basic information
Public title
Changes in muscle oxygenation status by muscle electrical stimulation for patients admitted to intensive care unit
Acronym
Changes in muscle oxygenation status by muscle electrical stimulation for patients admitted to intensive care unit
Scientific Title
Changes in muscle oxygenation status by muscle electrical stimulation for patients admitted to intensive care unit
Scientific Title:Acronym
Changes in muscle oxygenation status by muscle electrical stimulation for patients admitted to intensive care unit
Region
| Japan |
Condition
Condition
Patients admitted to ICU
Classification by specialty
| Intensive care medicine | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To invastigate muscle oxygenation status during electric muscle stimulation to bilateral lower limbs in patients admitted to ICU using near infrared spectroscopy.
Basic objectives2
Others
Basic objectives -Others
Pathophysiological analysis
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Muscle oxygentaion status in gastrocnemius muscle and vastus lateralis muscle during eletrical muscle stimulation (1st,7th,14th day after EMS trainig)
Key secondary outcomes
Vital signs, SpO2, and lactate before and after eletrical muscle stimulation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Electrical muscle stimulation: bilateral lower limb muscles, Muscle contracion can be recognized, 20 min per day, up to 14 days)
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients admitted to ICU
Key exclusion criteria
Trauma or skin disorder in abdomen and/or lower limbs
Leg edema
Cervical spinal cord injury (C1-C5)
Drug overdose
Suicide
Post resustitaion
Venous thrombosis in lower limbs
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Kutsuzawa |
Organization
Tokai University
Division name
School of Medicine
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463-93-1121
tkutsu@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Kutsuzawa |
Organization
Tokai University
Division name
School of Medicine
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463-93-1121
Homepage URL
tkutsu@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
Tokai University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board for Clinical Research, Tokai University
Address
143 shimokasuya, Isehara, Kanagawa
Tel
0463-93-1121
tokai-rinsho@ml.tokai-u.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
東海大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 06 | Day |
Related information
URL releasing protocol
https://www.u-tokai.ac.jp/uploads/2025/03/37.pdf
Publication of results
Published
Result
URL related to results and publications
https://www.u-tokai.ac.jp/uploads/2025/03/37.pdf
Number of participants that the trial has enrolled
5
Results
Only the 1st measurement of the 3 of 5 patients was analyzed, as voluntary movements of the patients' lower limbs occurred during the electrical muscle stimulation (EMS). No changes in vital signs were observed after EMS, with no hypoxemia. Moreover, no muscle desaturation was detected. Total-Hb/Mb and oxy-Hb/Mb were increased in the GM muscles of cases 1 and 3 after EMS. VL muscles exhibited lower each Hb/Mb than GM muscles, possibly due to the low stimulus intensity.
Results date posted
| 2025 | Year | 03 | Month | 17 | Day |
Results Delayed
Results Delay Reason
The study period was extended, but the number of cases could not be collected, and it was decided to report the cases as a case series.
Date of the first journal publication of results
| 2025 | Year | 03 | Month | 31 | Day |
Baseline Characteristics
Patients admitted to ICU
(i) Patients admitted to the ICU aged between 20 and 80 years old
(ii) Transcutaneous oxygen saturation (SpO2 ) 93% or more
(iii) No abnormal vital signs
(iv) Excluding acute drug intoxication, suicide attempt, resuscitation after cardiopulmonary arrest on arrival, 1st to 5th cervical vertebra injury, and old cerebrovascular disease.
(v) Patients with burns, trauma or injury to the belt electrode site (abdomen, thighs, lower legs), excluding lower limb oedema and lower limb venous thrombus
Participant flow
Eligible ICU patients are selected, the study is explained in writing and verbally to the patient or surrogate and consent is obtained in writing.
EMS of the whole lower limb for 14 days from the date of stabilisation of vital signs and improvement of cerebral oedema; NIRS measurements during EMS on days 1, 7 and 14.
Study completed at the end of 14 days of EMS or ICU discharge.
Adverse events
None
Outcome measures
Near infrared spectroscopy (NIRS), oxygenated-Hb/Mb, deoxygenated-Hb/Mb, total-Hb/Mb
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 04 | Day |
Last modified on
| 2025 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042461
