UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048809 |
|---|---|
| Receipt number | R000055610 |
| Scientific Title | Development of a method for determining optimal exercise intensity using sweat lactate sensor under hypoxia |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2022/10/09 10:30:00 |
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Basic information
Public title
Development of a method for determining optimal exercise intensity using sweat lactate sensor under hypoxia
Acronym
Development of a method for determining optimal exercise intensity using sweat lactate sensor under hypoxia
Scientific Title
Development of a method for determining optimal exercise intensity using sweat lactate sensor under hypoxia
Scientific Title:Acronym
Development of a method for determining optimal exercise intensity using sweat lactate sensor under hypoxia
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the accuracy of sweat LT measurements in cyclists under hypoxia and the relationship between FTP and sweat LT
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between sweat LT and AT under hypoxic environment
Key secondary outcomes
1) Comparison of power at VO2max obtained by expiratory gas analysis with the maximum average power per minute during the progressive load test
2) Calculate the percentage of MAP of power in sweat LT and verify the variation of eigenvalues
3) Comparison of changes in skeletal muscle tissue oxygen saturation and maximum exercise intensity (exercise duration, maximum exercise load, maximum oxygen uptake)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
After pedaling exercise in a normoxic environment, perform pedaling exercise in a hypoxic environment (15%) within one month. Each pedaling time is about 10-20 minutes.
Interventions/Control_2
After pedaling exercise in a hypoxic environment (15%), perform pedaling exercise in a normoxic environment within one month. Each pedaling time is about 10-20 minutes.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Healthy adults aged 18 years or older with no medical history and taking no medications
2. Those who are training for the purpose of cycling
Key exclusion criteria
1.Those who are judged by the research representative/co-investigators to be unsuitable for this study
2. Subjects who cannot exercise enough due to trauma, etc.
3.Those who have a smoking history and habit
4.People who have a habit of taking medicine
5. Subjects who habitually take supplements
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Katsumata |
| Middle name | |
| Last name | Yoshinori |
Organization
Keio University
Division name
School of Medicine, Institute for Integrated Sports Medicine
Zip code
160-0016
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
TEL
03-5269-9054
goodcentury21@keio.jp
Public contact
Name of contact person
| 1st name | Katsumata |
| Middle name | |
| Last name | Yoshinori |
Organization
Keio University
Division name
School of Medicine, Institute for Integrated Sports Medicine
Zip code
160-0016
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
TEL
03-5269-9054
Homepage URL
goodcentury21@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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 | 09 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 08 | Month | 31 | Day |
Last modified on
| 2022 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055610
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
