UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047208 |
|---|---|
| Receipt number | R000053845 |
| Scientific Title | Study on sweat sodium excretion during exercise |
| Date of disclosure of the study information | 2022/03/22 |
| Last modified on | 2023/02/27 15:15:32 |
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Basic information
Public title
Study on sweat sodium excretion during exercise
Acronym
Study on sweat sodium excretion during exercise
Scientific Title
Study on sweat sodium excretion during exercise
Scientific Title:Acronym
Study on sweat sodium excretion during exercise
Region
| Japan |
Condition
Condition
Normal
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate sweat sodium excretion during exercises.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sweat sodium excretion during incremental and constant exercise load
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Incremental exercise load test
Interventions/Control_2
Constant exercise load test (low intensity)
Interventions/Control_3
Constant exercise load test (Middle intensity)
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
| 22 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Female university student
(2) must be in good physical condition.
(3) those who voluntarily participate in this study with written informed consent.
Key exclusion criteria
Subjects with heart disease and/or respiratory disease and/or injury
Subjects receiving treatment (medicine prescription by physician)
Subjects who are judged as unsuitable for this study by physician
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Michiyo |
| Middle name | |
| Last name | Kimura |
Organization
Takasaki University of Health and Welfare
Division name
Faculty of Health and Welfare
Zip code
370-0033
Address
37-1 Nakaorui,Takasaki city,Gunma
TEL
0273521290
mura@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Michiyo |
| Middle name | |
| Last name | Kimura |
Organization
Takasaki University of Health and Welfare
Division name
Faculty of Health and Welfare
Zip code
3700033
Address
37-1 Nakaorui,Takasaki city,Gunma
TEL
0273521290
Homepage URL
kimura@takasaki-u.ac.jp
Sponsor or person
Institute
Takasaki University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Takasaki University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Takasaki University of Health and Welfare
Address
37-1 Nakaorui,Takasaki city,Gunma
Tel
0273521290
mune@takasaki-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
| 2022 | Year | 03 | Month | 22 | 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
| 2022 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2023 | 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 | 03 | Month | 18 | Day |
Last modified on
| 2023 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053845
