UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016276 |
|---|---|
| Receipt number | R000018885 |
| Scientific Title | Effects of functional clothing fabric under different light conditions on heart rate variability in human |
| Date of disclosure of the study information | 2015/01/20 |
| Last modified on | 2021/09/23 18:15:19 |
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Basic information
Public title
Effects of functional clothing fabric under different light conditions on heart rate variability in human
Acronym
Effects of functional clothing fabric under different light conditions on heart rate variability in human
Scientific Title
Effects of functional clothing fabric under different light conditions on heart rate variability in human
Scientific Title:Acronym
Effects of functional clothing fabric under different light conditions on heart rate variability in human
Region
| Japan |
Condition
Condition
healthy general people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
functional evaluation of clothing
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
difference of before and after (exercise) by heart rate variability
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
4 conditions in random order (light A/clothing A, light A/clothing B, light B/clothing A, light B/clothing B)
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
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
healthy adult male
Key exclusion criteria
1) mental disease
2) extreme morning-type or evening-type
3) sleep disorder
4) smoking
5) BMI over 30kg/m2
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | tomoko |
| Middle name | |
| Last name | wakamura |
Organization
Graduate School of Medicine Kyoto University
Division name
human health science
Zip code
6068507
Address
53 Kawaharacho Shogoin Sakyoku Kyoto-city Kyoto-prefecture
TEL
0757513974
wakamura.tomoko.5v@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Wakamura |
Organization
Graduate School of Medicine Kyoto University
Division name
human health science
Zip code
6068507
Address
53 Kawaharacho Shogoin Sakyoku Kyoto-city Kyoto-prefecture
TEL
075-751-3974
Homepage URL
wakamura.tomoko.5v@kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto University Uneihi-koufukin
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
(tel)075-753-4680
ethcom@kuhp.kyoto-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
| 2015 | Year | 01 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2015 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2015 | Year | 09 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 20 | Day |
Last modified on
| 2021 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018885
