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

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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 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


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

Value
https://center6.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