UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026334 |
|---|---|
| Receipt number | R000030183 |
| Scientific Title | Influence of the activities and physical condition has on the cytokine expression by electrical stimulation |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2017/02/28 14:37:17 |
* 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
Influence of the activities and physical condition has on the cytokine expression by electrical stimulation
Acronym
Influence of the activities and physical condition has on the cytokine expression by electrical stimulation
Scientific Title
Influence of the activities and physical condition has on the cytokine expression by electrical stimulation
Scientific Title:Acronym
Influence of the activities and physical condition has on the cytokine expression by electrical stimulation
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploratory study on the relationship between cytokine expression level and physical function by myoelectric electrical stimulation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Expression level of 40 types of cytokines by muscle electrical stimulation:
Eotaxin, Eotaxin-2, GCSF, GM-CSF, ICAM-1, IFN-gamma, I-309, IL-1alpha, IL-1beta, IL-2, IL-3, IL-4, IL-6, IL-6sR, IL-7, IL-8, IL-10, IL-11, IL-12p40, IL-12p70, IL-13, IL-15, IL-16, IL-17, IP-10, MCP-1, MCP-2, M-CSF, MIG, MIP-1alpha, MIP-1beta, MIP-1delta, RANTES, TGF-beta1, TNF-alpha, TNF-beta, sTNF RI, sTNF-RII, PDGF-BB, TIMP-2
Key secondary outcomes
knee extension muscle strength, oxygen uptake at rest, peak oxygen uptake
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
Muscle electrical stimulation
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
| 26 | years-old | >= |
Gender
Male
Key inclusion criteria
To participate in this research, those who can acquire document consent by their free will with sufficient understanding after receiving sufficient explanation and for healthy volunteers aged 20 to 26 when acquiring consent.
Key exclusion criteria
Those who have disorders that are thought to affect metabolism such as heart failure, diabetes, etc., those who are at risk for intervention such as epilepsy, others who have judged that it is inappropriate by the research director, the research sharing person.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Momota |
Organization
Fujita Health University
Division name
School of Health Science
Zip code
Address
1-98 Dengakugakubo,Kutsukake,Tyoake,Aichi,Japan
TEL
+81-562-93-9000
momo@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Momota |
Organization
Fujita Health University
Division name
School of Health Science
Zip code
Address
1-98 Dengakugakubo,Kutsukake,Tyoake,Aichi,Japan
TEL
+81-562-93-9000
Homepage URL
momo@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
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
Address
Tel
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
| 2018 | Year | 04 | Month | 01 | 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
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 28 | Day |
Last modified on
| 2017 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030183
