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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032518
Receipt No. 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

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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
Email 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
Email ochitani@huma-c.co.jp

Sponsor
Institute HUMA R&D CORP
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037084

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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