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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039714
Receipt No. 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 2020/09/03

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

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
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 Preinitiation
Date of protocol fixation
2020 Year 03 Month 05 Day
Date of IRB
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 03 Month 05 Day
Last modified on
2020 Year 09 Month 03 Day


Link to view the page
URL(English) https://upload.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


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