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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000044183
Receipt No. 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

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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
Email 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
Email yuishii@fancl.co.jp

Sponsor
Institute FANCL Corporation
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050457

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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