UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053580 |
|---|---|
| Receipt number | R000061146 |
| Scientific Title | Effects of sunburn on exercise performance |
| Date of disclosure of the study information | 2024/02/09 |
| Last modified on | 2024/02/09 15:35:26 |
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Basic information
Public title
Effects of sunburn on exercise performance
Acronym
Sunburn and performance
Scientific Title
Effects of sunburn on exercise performance
Scientific Title:Acronym
Sunburn and performance
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effects of sunburn on immune function, oxidative stress, fatigue, and exercise performance.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exercise performance (grip strength, vertical jump, reaction time, agility, anaerobic capacity) at 6 hours after sunburn
Key secondary outcomes
Salivary biomarkers, urinary biomarkers, autonomic nerve activity, mood states, and fatigue
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Sunburn equivalent to minimal erythema dose (MED)
Interventions/Control_2
Rest for the same amount of time as MED
Interventions/Control_3
Sunburn equivalent to twofold MED
Interventions/Control_4
Rest for the same amount of time as twofold MED
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Persons who are able to obtain free and voluntary consent to participate in research in writing from the individual
Men and women between the ages of 18 and 40 at the time of consent
Persons who are willing to comply with the study protocol and agree to participate in the study
Key exclusion criteria
Women who are pregnant or may become pregnant
Persons who are considered to have difficulty in daily living due to surgical injuries or medical conditions
Subjects who have difficulty in exposing themselves to ultraviolet rays of the sun due to skin diseases, photosensitivity, etc.
Persons who are deemed inappropriate as subjects for this study by the principal investigator and the person in charge of the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiko |
| Middle name | |
| Last name | Eda |
Organization
Dokkyo Medical University
Division name
Premedical Sciences, Department of Fundamental Education
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Shimotsugagun, Tochigi, Japan
TEL
0282-87-2119
n-eda@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Nobuhiko |
| Middle name | |
| Last name | Eda |
Organization
Dokkyo Medical University
Division name
Premedical Sciences, Department of Fundamental Education
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Shimotsugagun, Tochigi, Japan
TEL
0282-87-2119
Homepage URL
n-eda@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Bioethics Committee, Dokkyo Medical University
Address
880 Kitakobayashi, Mibu, Shimotsugagun, Tochigi, Japan
Tel
0282-87-2474
kenkyu@dokkyomed.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
| 2024 | Year | 02 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 14 | 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
Management information
Registered date
| 2024 | Year | 02 | Month | 09 | Day |
Last modified on
| 2024 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061146
| 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 |
