UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039714
Receipt number R000045289
Scientific Title The verification study for safety evaluation of exercise in normal pressure and hypoxia among healthy people
Date of disclosure of the study information 2020/03/05
Last modified on 2021/03/04 17:22:29

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Basic information

Public title

The safety test of exercise in normal pressure and hypoxia

Acronym

The safety test of exercise in normal pressure and hypoxia

Scientific Title

The verification study for safety evaluation of exercise in normal pressure and hypoxia among healthy people

Scientific Title:Acronym

The verification study for safety evaluation of exercise in normal pressure and hypoxia among healthy people

Region

Japan


Condition

Condition

None

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Verification of safety on exercise load under normal pressure and low oxygen environment

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Achievement rate by exercise load

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

Uncontrolled

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Exercise load by using health equipment
(Set the oxygen concentration to 20%, 18%, 16%)

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

59 years-old >=

Gender

Male and Female

Key inclusion criteria

1. No disease
2. Between 20 and 59 years old
3. Can exercise for over 30 minutes from walking to jogging on a treadmill
4. Understand the purpose and content of this research sufficiently and have sufficient decision-making ability

Key exclusion criteria

1. Take healthy foods (ex. supplements) regularly
2. Pregnant or possibility of becoming pregnant
3. Systolic blood pressure is 140mmHg or more or diastolic blood pressure is 80mmHg or more
4. Heart rate is 100 beats per minute or more
5. Oxygen saturation is 95% or less
6. Body temperature is 37.0 degrees or more
7. Have an urgent and obvious life crisis
8. Participants in other clinical trials

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Kazuya
Middle name
Last name Yamagata

Organization

Faculty of Life Sciences, Kumamoto University

Division name

Center of Metabolic Regulation of Healthy Aging

Zip code

860-8556

Address

1-1-1 Honjo, Chuo-ku, Kumamoto

TEL

096-373-5657

Email

k-yamaga@kumamoto-u.ac.jp


Public contact

Name of contact person

1st name Korin
Middle name
Last name Sakakida

Organization

Kumamoto University Hospital

Division name

Department of General Clinical Research

Zip code

860-8556

Address

1-1-1 Honjo, Chuo-ku, Kumamoto

TEL

096-373-5575

Homepage URL


Email

korin@kumamoto-u.ac.jp


Sponsor or person

Institute

Faculty of Life Sciences, Kumamoto University
Center of Metabolic Regulation of Healthy Aging

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Faculty of Life Sciences, Kumamoto University

Address

1-1-1 Honjo, Chuo-ku, Kumamoto

Tel

096-373-5966

Email

byi-senshin@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

2020 Year 03 Month 05 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

40

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

2020 Year 03 Month 05 Day

Date of IRB

2020 Year 06 Month 09 Day

Anticipated trial start date

2020 Year 04 Month 01 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry

2021 Year 03 Month 31 Day

Date trial data considered complete

2021 Year 03 Month 31 Day

Date analysis concluded

2021 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2020 Year 03 Month 05 Day

Last modified on

2021 Year 03 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045289


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name