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
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
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
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
