UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045289