UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000031282 |
|---|---|
| Receipt number | R000035629 |
| Scientific Title | Study to verify the effect of walking with a specially processed insole |
| Date of disclosure of the study information | 2018/02/20 |
| Last modified on | 2019/01/28 18:24:02 |
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Basic information
Public title
Study to verify the effect of walking with a specially processed insole
Acronym
Study to verify the effect of walking with a specially processed insole
Scientific Title
Study to verify the effect of walking with a specially processed insole
Scientific Title:Acronym
Study to verify the effect of walking with a specially processed insole
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
While walking is good, the muscle load is imposed on the sandy beach walking training image, stimulation of Growth hormone (GH) secretion promotion, effects such as lowering of Glucose and Triglyceride is to be brought about by special processing insole.We hope to promote the health of the people through walking, and aim for LOCOMO countermeasures.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Growth hormone before and after walking
Key secondary outcomes
Cortisol, Triglyceride, Glucose, Insulin before and after walking
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Wear the test item and conduct walking (30 minutes) about 3 METS (normal walking degree).
Interventions/Control_2
Wear a control item and perform walking (about 30 minutes) about 3 METS (normal walking degree).
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
| 25 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
Individuals who belong to or are related to Kanazawa Urata Clinic and who do not conflict with exclusion criteria
Key exclusion criteria
[1]Individuals using medical products
[2]Individuals with serious medical history / current medical history
[3]Individuals with serious anemia
[4]Individuals who are pregnant or are posslibly, or are lactating
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Yonei |
Organization
Faculty of Life and Medical Sciences,Doshisha University
Division name
Anti-Aging Medical Research Center
Zip code
Address
1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
TEL
0774-65-6394
yyonei@mail.doshisha.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seigo Isozaki |
Organization
Faculty of Life and Medical Sciences,Doshisha University
Division name
Anti-Aging Medical Research Center
Zip code
Address
1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
TEL
0774-65-6394
Homepage URL
isozaki@yonei-labo.com
Sponsor or person
Institute
Doshisha University
Institute
Department
Personal name
Funding Source
Organization
ASICS Trading Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
金沢浦田クリニック（石川県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.toukastress.jp/webj/article/2018/GS18-21.pdf
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
| 2018 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 20 | 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
| 2018 | Year | 02 | Month | 13 | Day |
Last modified on
| 2019 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035629
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
