UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051366 |
|---|---|
| Receipt number | R000058603 |
| Scientific Title | Validation of a method for the assessment of optimal exercise intensity using a percutaneous oxygen saturation |
| Date of disclosure of the study information | 2023/06/16 |
| Last modified on | 2023/12/19 20:07:21 |
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Basic information
Public title
Validation of a method for the assessment of optimal exercise intensity using a percutaneous oxygen saturation
Acronym
Validation of a method for the assessment of optimal exercise intensity using a percutaneous oxygen saturation
Scientific Title
Validation of a method for the assessment of optimal exercise intensity using a percutaneous oxygen saturation
Scientific Title:Acronym
Validation of a method for the assessment of optimal exercise intensity using a percutaneous oxygen saturation
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to investigate the validation for assessing the optimal exercise intensity using a simple non-invasive measurement method of percutaneous oxygen saturation in compared with the blood lactate, expiratory gas markers and double product (rate pressure product) responses.
Basic objectives2
Others
Basic objectives -Others
reliability
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
percutaneous oxygen saturation
Key secondary outcomes
blood lactate accumulation
oxygen consumption
carbon dioxide production
heart rate
systolic blood pressure
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
| 18 | years-old | <= |
Age-upper limit
| 45 | years-old | > |
Gender
Male and Female
Key inclusion criteria
People who fully understand the purpose of research, risks associated with the research intervention, obligations and consequences of research participation, and his/her right of withdrawing consent any time during the study
Key exclusion criteria
1) People who have concomitant diseases/injuries affecting enforcement of safety physical activity, 2) with a history of cardiovascular disease including resent myocardial infarction, 3) severe lever or kidney diseases, 4) hypertension or diabetes mellitus, 5) a person who is scheduled to have an operation (surgery), 6) a patient who is recovering/treatment from/in other serious diseases, and 7) during pregnancy
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Kumahara |
Organization
Nakamura Gakuen University
Division name
Faculty of Nutritional Sciences
Zip code
814-0198
Address
5-7-1 Befu, Jonan-ku, Fukuoka 814-0198, Japan
TEL
092-851-2531
kumahara-h@umin.ac.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Kumahara |
Organization
Nakamura Gakuen University
Division name
Faculty of Nutritional Sciences
Zip code
814-0198
Address
5-7-1 Befu, Jonan-ku, Fukuoka 814-0198, Japan
TEL
092-851-2531
Homepage URL
kumahara-h@umin.ac.jp
Sponsor or person
Institute
Nakamura Gakuen University
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
Nakamura Gakuen University
Address
5-7-1 Befu, Jonan-ku, Fukuoka 814-0198, Japan
Tel
092-851-2531
kks@nakamura-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
| 2023 | Year | 06 | Month | 16 | 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
Suspended
Date of protocol fixation
| 2023 | Year | 04 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The validation for assessing the optimal exercise intensity using a simple non-invasive measurement method of blood oxygen saturation during an incremental exercise load in compared with the conventional methods.
Management information
Registered date
| 2023 | Year | 06 | Month | 16 | Day |
Last modified on
| 2023 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058603
| 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 |
