UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000035617
Receipt number R000040575
Scientific Title Clinical investigation for the early effects of physical exercise on concentrations of aging-related biomarkers in circulation
Date of disclosure of the study information 2019/01/23
Last modified on 2021/01/22 17:17:32

* 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

Clinical investigation for the early effects of physical exercise on concentrations of aging-related biomarkers in circulation

Acronym

Clinical investigation for the early effects of physical exercise on concentrations of aging-related biomarkers in circulation

Scientific Title

Clinical investigation for the early effects of physical exercise on concentrations of aging-related biomarkers in circulation

Scientific Title:Acronym

Clinical investigation for the early effects of physical exercise on concentrations of aging-related biomarkers in circulation

Region

Japan


Condition

Condition

normal individuals

Classification by specialty

Endocrinology and Metabolism Geriatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate early effect of exercise on human health status and circulating level of aging-related factors.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluating percentage of participants of whom circulating ANGPTL2 level is decreased by exercise.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Stretching exercise, or walking exercise

Interventions/Control_2


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


Not applicable

Gender

Male and Female

Key inclusion criteria

Adult individuals without daily habits of exercise.

Key exclusion criteria

<20 years old, severe diabetes, severe heart disease, severe lung disease, severe liver disease, severe kidney disease, severe peripheral artery disease, severe cancer, severe dementia, without routine medical check in 2017, or inappropriate by the judgment of the doctor.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Yuichi
Middle name
Last name Oike

Organization

Graduate School of Medical Sciences, Kumamoto University

Division name

Department of Molecular Genetics

Zip code

8608556

Address

1-1-1 Honjyo, Chuo-ku, Kumamoto, Kumamoto, Japan

TEL

096-373-5142

Email

olegene@kumamoto-u.ac.jp


Public contact

Name of contact person

1st name Jun
Middle name
Last name Morinaga

Organization

Graduate School of Medical Sciences, Kumamoto University

Division name

Department of Molecular Genetics

Zip code

8608556

Address

1-1-1 Honjyo, Chuo-ku, Kumamoto, Kumamoto, Japan

TEL

096-373-5142

Homepage URL


Email

morijun@kumamoto-u.ac.jp


Sponsor or person

Institute

Kumamoto University

Institute

Department

Personal name



Funding Source

Organization

Saishunkan 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

Ethics Committee of Kumamoto University

Address

1-1-1, Honjo, Chuo-ku, Kumamoto City, japan

Tel

096-373-5657

Email

ski-shien@jimu.kumamoto-u.ac.jp


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

2019 Year 01 Month 23 Day


Related information

URL releasing protocol

Unpublished

Publication of results

Unpublished


Result

URL related to results and publications

Unpublished

Number of participants that the trial has enrolled

50

Results

No significant effect of physical exercise on aging-related biomarkers was observed.

Results date posted

2021 Year 01 Month 22 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

General workers.

Participant flow

After study enrolment, participants performed exercise for one week.

Adverse events

No.

Outcome measures

Circulating levels of aging related biomarkers.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 11 Month 08 Day

Date of IRB

2018 Year 11 Month 08 Day

Anticipated trial start date

2019 Year 01 Month 01 Day

Last follow-up date

2019 Year 01 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 01 Month 22 Day

Last modified on

2021 Year 01 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040575


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name