UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032566 |
|---|---|
| Receipt number | R000037136 |
| Scientific Title | Changes in muscle oxygenation state during different intensity of electrical stimulation between thigh and lower leg muscle in adult male |
| Date of disclosure of the study information | 2018/05/20 |
| Last modified on | 2024/03/06 12:25:48 |
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Basic information
Public title
Changes in muscle oxygenation state during different intensity of electrical stimulation between thigh and lower leg muscle in adult male
Acronym
Muscle oxygenation state during electrical stimulation between thigh and lower leg muscle
Scientific Title
Changes in muscle oxygenation state during different intensity of electrical stimulation between thigh and lower leg muscle in adult male
Scientific Title:Acronym
Muscle oxygenation state during electrical stimulation between thigh and lower leg muscle
Region
| Japan |
Condition
Condition
ICU-acquired muscle weakness
Classification by specialty
| Intensive care medicine | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the oxygenation state of gastrocnemius and vastus lateralis muslces during same intensity of electrical stimulation or different intensity to each muscle.
Basic objectives2
Others
Basic objectives -Others
To determine the influence of different intensity between thigh and lower leg muscles on oxygenation state and blood volume.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in muscle oxygenation state (total-Hb/Mb, oxy-Hb/Mb, deoxy-Hb/Mb, TOI, THI) during electrical muscle stimulation
Key secondary outcomes
Blood pressure, SpO2
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Electrical stimulation, 15 min
Intensity
a) Thigh : Lower leg, 1:1
b) Thigh : Lower leg, 2:1
Interventions_1: a) -> wash out (at least 7days) -> b)
Interventions/Control_2
Electrical stimulation, 15 min
Intensity
a) Thigh : Lower leg, 1:1
b) Thigh : Lower leg, 2:1
Interventions_2: b) -> wash out (at least 7 days) -> a)
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
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
1. 20 years-old <= healthy man < 40 years-old
2. Independence of ADL
3. Normal lung function
4. Written informed consent was obtained.
Key exclusion criteria
1. Abnormal Vital signs
1) BT: <35.0 degree centigrade, 38.0 degree centigrade<=
2) PR: <50 bpm, 130 bpm<=
3) syst. BP: <90 mmHg, 180 mmhg <=
4) SpO2: <93%
2. Neuromuscular disease (MG, ALS, etc), cerebrovascular disease (lower limb paresis)
3. Severe heart disease, renal failure, hepatic failure, DM
4. Disease of lower limb (trauma, infection, joint disorder, varix, deep vein thrombos, obstructive arteriosclerotic disease, severe edema).
5. Pain in muscles and joint of lower extremity.
6. Using steroid, anti-coagulant, or anti-platelet agents.
7. BMI 27<=
8. Allergy of Latex or surgical tape
9. Subjects who are considered ineligible by the principal or other investigators.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Kutsuzawa |
Organization
Tokai University
Division name
Graduate School of Health Sciences
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
Graduate School of Health Sciences
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
None
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（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 20 | Day |
Related information
URL releasing protocol
https://doi.org/10.15032/jsrcr.29.supplement_157s
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.15032/jsrcr.29.supplement_157s
Number of participants that the trial has enrolled
6
Results
Muscle oxygenation kinetics were divided into three types based on changes in total- hemoglobin/myoglobin: the usual type (the same changes as in voluntary exercise), the increase type, and the unchanged type. The ratio of normal/increased/no change was 2:3:1 for the vastus lateralis muscle and 3:2:1 for the gastrocnemius muscle. Stimulus intensity 1:1 and 1:2 did not change this type.
Results date posted
| 2024 | Year | 03 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Age of the 6 subjects: 29.5 (2.6) years, BMI: 22.3 (2.5) (one subject was 26.8 kg/m2), Subcutaneous fat thickness of the vastus lateralis muscle: 6.5 (2.0) mm (2 subjects: 9.5 mm and 10.0 mm), those of the gastrocnemius muscle: 4.2 (2.1) mm.
Data were shown as mean (SD).
Participant flow
Posters inviting volunteers are placed in the facility where the researcher works to recruit study participants. The researcher explains the study in writing to the study participants and obtains written consent. The first bout muscle electrical stimulation was performed after a medical interview, blood pressure, pulse rate, and transcutaneous oxygen saturation were measured. The second bout was performed at least one week later.
Adverse events
None
Outcome measures
Muscle oxygenation status of the vastus lateralis and gastrocnemius muscles during muscle electrical stimulation.
Blood pressure, pulse rate, and transcutaneous oxygen saturation.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2021 | Year | 08 | 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
| 2018 | Year | 05 | Month | 12 | Day |
Last modified on
| 2024 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037136
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