UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049277 |
|---|---|
| Receipt number | R000056116 |
| Scientific Title | Measurement of anaerobic threshold and respiratory compensation point using blood oxygen saturation |
| Date of disclosure of the study information | 2022/11/01 |
| Last modified on | 2023/04/24 17:18:54 |
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Basic information
Public title
Examination of simple measurement method of anaerobic threshold and respiratory compensation point
Acronym
Examination of simple measurement method of anaerobic threshold and respiratory compensation point
Scientific Title
Measurement of anaerobic threshold and respiratory compensation point using blood oxygen saturation
Scientific Title:Acronym
Measurement of anaerobic threshold and respiratory compensation point 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 and respiratory compensation point using blood oxygen saturation
Basic objectives2
Others
Basic objectives -Others
Exercise intensity
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Anaerobic threshold and respiratory compensation point
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Exercise
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. Men and women between the ages of 20 and 65.
2. BMI of 18.5 or more and less than 30.0 kg/m2.
Key exclusion criteria
1. Subjects with severe respiratory disease, liver diseases, digestive organ diseases, kidney diseases and heart diseases.
2. Subjects who are resistant to high-intensity exercise.
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
30
Research contact person
Name of lead principal investigator
| 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
TEL
045-820-3419
yuishii@fancl.co.jp
Public contact
Name of contact person
| 1st name | Masatsugu |
| Middle name | |
| Last name | Abe |
Organization
New Business Division
Division name
New Business Promotion Department
Zip code
231-8528
Address
89-1 Yamashita-cho, Naka-ku, Yokohama
TEL
045-226-1044
Homepage URL
abe_masatsugu@fancl.co.jp
Sponsor or person
Institute
FANCL Research Institute
Institute
Department
Personal name
Funding Source
Organization
FANCL Research Institute
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
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | 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
34
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 | 09 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 20 | Day |
Last modified on
| 2023 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056116
| 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 |
