UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044183 |
|---|---|
| Receipt number | R000050457 |
| Scientific Title | Measurement of anaerobic threshold using blood oxygen saturation -Pilot Study- |
| Date of disclosure of the study information | 2021/07/01 |
| Last modified on | 2021/11/17 09:24:12 |
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Basic information
Public title
Examination of simple measurement method of anaerobic threshold
Acronym
Examination of simple measurement method of anaerobic threshold
Scientific Title
Measurement of anaerobic threshold using blood oxygen saturation -Pilot Study-
Scientific Title:Acronym
Measurement of anaerobic threshold using blood oxygen saturation
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of measurement method of anaerobic threshold using blood oxygen saturation
Basic objectives2
Others
Basic objectives -Others
Verify the validity of the inspection method
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exercise intensity corresponding to the anaerobic threshold
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Age: 20 -65 years old
2. Sex : Male or Female
3. BMI:18.5 -25.0 kg/m^2
4. Written informed consent
Key exclusion criteria
1. Subjects with severe liver diseases, digestive organ diseases, kidney diseases and heart diseases.
2. Subjects who are planned to participate in other clinical study.
3. Subjects who intend to become pregnant or lactating.
4. Subjects infected with coronavirus (COVID-19) or who fall under close contact with infected persons
5. Subjects with exercise-induced diseases such as exercise-induced arrhythmia and exercise-induced anaphylaxis and exercise equipment disorders
6. Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Yui |
Organization
FANCL Corporation
Division name
Research Institute, Health science research center
Zip code
244-0806
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3443
ke-yui@fancl.co.jp
Public contact
Name of contact person
| 1st name | Yuri |
| Middle name | |
| Last name | Ishii |
Organization
FANCL Corporation
Division name
Research Institute, Health science research center
Zip code
244-0806
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
TEL
045-820-3419
Homepage URL
yuishii@fancl.co.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
FANCL Corporation Clinical Research Ethics Committee
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
Tel
045-820-3657
akihide_nisihara@fancl.co.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
株式会社ファンケル 総合研究所（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | 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
| 2021 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The validity of the new method is verified by determining the anaerobic threshold point from the blood oxygen saturation during exercise load and comparing the exercise intensity at that point with the existing method.
Management information
Registered date
| 2021 | Year | 05 | Month | 12 | Day |
Last modified on
| 2021 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050457
