UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032518 |
|---|---|
| Receipt number | R000037084 |
| Scientific Title | Investigation of the Effect of Walking with the Test Product (Shoes) on Muscle Activity. |
| Date of disclosure of the study information | 2018/05/14 |
| Last modified on | 2018/07/11 13:52:32 |
* 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
Investigation of the Effect of Walking with the Test Product (Shoes) on Muscle Activity.
Acronym
Investigation of the Effect of Walking with the Test Product (Shoes) on Muscle Activity.
Scientific Title
Investigation of the Effect of Walking with the Test Product (Shoes) on Muscle Activity.
Scientific Title:Acronym
Investigation of the Effect of Walking with the Test Product (Shoes) on Muscle Activity.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study was to investigate the effect of walking test products (shoes) on muscle activity in healthy Japanese women aged 30 years or older and younger than 55 years.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Electromyography
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
2-minute use of the test product
Wash out
2-minute use of the placebo product
Interventions/Control_2
2-minute use of the placebo product
Wash out
2-minute use of the test product
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
| 30 | years-old | <= |
Age-upper limit
| 55 | years-old | > |
Gender
Female
Key inclusion criteria
1)Age: 30 years or older, less than 55 years of age
2)Gender: Japanese women
3)Foot Size: 22.5 cm to 23.5 cm
Key exclusion criteria
1)Persons currently receiving any medication or outpatient treatment
2)History of liver disease or serious renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, metabolic disease
3)Persons with a history of drug or food allergy
4)Persons with a history of injury or surgery affecting gait
5)Individuals with extreme predation
6)Extremely irregular lifestyle, such as eating or sleeping
7)Persons with sleep disorders
8)Persons with a current or past history of psychiatric disorders (e.g., depression)
9)Persons with a current or past history of alcoholism
10)Those who are currently participating in other clinical studies or have participated in other clinical studies within the past 3 months
11)Pregnant, lactating women, or women who wish to become pregnant during the study
12)Persons with irregular working hours, such as night shifts
13)Other subjects who are considered inappropriate for inclusion in the study by the investigator
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ochitani Daisuke |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
Address
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
81-3-3431-1260
ochitani@huma-c.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ochitani Daisuke |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
Address
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
81-3-3431-1260
Homepage URL
ochitani@huma-c.co.jp
Sponsor or person
Institute
HUMA R&D CORP
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 14 | 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
| 2018 | Year | 04 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | Month | 14 | 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 | 05 | Month | 08 | Day |
Last modified on
| 2018 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037084
