UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047259 |
|---|---|
| Receipt number | R000053886 |
| Scientific Title | Clinical trial for the safety evaluation of exercise under hypoxia on Japanese elderly |
| Date of disclosure of the study information | 2022/05/01 |
| Last modified on | 2022/07/12 14:38:42 |
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Basic information
Public title
Clinical trial for the safety evaluation of exercise under hypoxia on Japanese elderly
Acronym
Clinical trial for the safety evaluation of exercise under hypoxia on Japanese elderly
Scientific Title
Clinical trial for the safety evaluation of exercise under hypoxia on Japanese elderly
Scientific Title:Acronym
Clinical trial for the safety evaluation of exercise under hypoxia on Japanese elderly
Region
| Japan |
Condition
Condition
Aging
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We plan to test the safety for the exercise under hypoxia on Japanese elderly
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We plan to test the safety for the exercise under hypoxia on Japanese elderly
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
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Participants are tested with exercise protocol under 20% oxygen, 18% oxygen, 16% oxygen.
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
| 60 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
We will enrolled the person
1.who is not treated with any other disease
2.whose age is above 60 years old under 75 years old
3.who can exercise for 30 minutes
4.who can understand what we explain about this trial
Key exclusion criteria
We will exclude the person
1.who take some drugs, supplement
2.who is pregnant
3.whose blood pressure is above 140/90mmHg
4.whose heart rate is above 100bpm
5.whose SpO2 is below 95% at room air
6.whose body temperature is above 37 degree
7.whose life is impending
8.who is enrolled with other clinical trial
9.who is considered as not suitable for this trial
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Eiichi |
| Middle name | |
| Last name | Araki |
Organization
Kumamoto University
Division name
Center for metabolic regulation of healthy aging
Zip code
8608556
Address
1-1-1 Honjyo, Kumamoto city, Kumamoto Prefecture
TEL
0963737380
fukudakazuki@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Fukuda |
Organization
Kumamoto University
Division name
Center for metabolic regulation of healthy aging
Zip code
8608556
Address
1-1-1 Honjyo, Kumamoto city, Kumamoto Prefecture
TEL
0963737380
Homepage URL
fukudakazuki@kumamoto-u.ac.jp
Sponsor or person
Institute
Center for metabolic regulation of healthy aging, Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Manpei Suzuki Diabetes Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kumamoto University Hospital Institutional Review Board
Address
1-1-1 Honjyo Kumamoto City, Kumamoto Prefecture
Tel
096-373-7380
fukudakazuki@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
| 2022 | Year | 05 | Month | 01 | 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
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 07 | 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
| 2022 | Year | 03 | Month | 23 | Day |
Last modified on
| 2022 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053886
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
