UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032566
Receipt No. 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 2019/05/13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email tkutsu@is.icc.u-tokai.ac.jp

Sponsor
Institute Tokai University
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 15
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 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
2019 Year 03 Month 25 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
2019 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037136

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.