UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015680
Receipt number R000018228
Scientific Title Fatigue recovery effect test of functional clothing article by a healthy person.
Date of disclosure of the study information 2014/11/13
Last modified on 2015/04/27 12:57:05

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Basic information

Public title

Fatigue recovery effect test of functional clothing article by a healthy person.

Acronym

Fatigue recovery effect test of functional clothing article by a healthy person.

Scientific Title

Fatigue recovery effect test of functional clothing article by a healthy person.

Scientific Title:Acronym

Fatigue recovery effect test of functional clothing article by a healthy person.

Region

Japan


Condition

Condition

Healthy individual.

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Exercise capacity measured when the functional clothing were used 1 week.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Blood lactate value change amaount after exercise bike rowing.

Key secondary outcomes

Blood glucose value change amount after exercise bike rowing.


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

new product group.

Interventions/Control_2

Conventional product group.

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

40 years-old >=

Gender

Male

Key inclusion criteria

Four days a week, those who the more exercise every two hours.

Key exclusion criteria

1)Heavy sequela or severe disease.
2)Heavy atopic dermatitis or systemic skin diseases such as psoriasis.
3)Systemic administration of immunosuppressive drugs or steroids.
4)The person who is unsuitable for the entry judged by a doctor and advisor to evaluate the movement.

Target sample size

18


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenichi Isoda, M.D.,Ph.D.

Organization

Mie University Hospital

Division name

Dermatology

Zip code


Address

2-174 Edobashi, Tsu, Mie 514-8507, Japan

TEL

059-232-1111

Email

isoda@clin.medic.mie-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Koji Umeda,Ph.D.

Organization

KSK Laboratories,Inc.

Division name

representative

Zip code


Address

t.c.p 4F,7-15 Daimon, Tsu, Mie 514-0027, Japan

TEL

059-253-8091

Homepage URL

http://www.ksk-lab.co.jp

Email

info@ksk-lab.co.jp


Sponsor or person

Institute

Mie University, Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

KSK Laboratories,Inc.

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

国立大学法人三重大学 総合研究棟2


Other administrative information

Date of disclosure of the study information

2014 Year 11 Month 13 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

2014 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 11 Month 15 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

2014 Year 11 Month 13 Day

Last modified on

2015 Year 04 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018228


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name