UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015549 |
|---|---|
| Receipt number | R000009556 |
| Scientific Title | Research on the living environment and lifestyle for the elderly to prevent heat disorders |
| Date of disclosure of the study information | 2014/10/28 |
| Last modified on | 2021/11/02 16:18:36 |
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Basic information
Public title
Research on the living environment and lifestyle for the elderly to prevent heat disorders
Acronym
Measurement of thermal environments and physiological value of the elderly in summer
Scientific Title
Research on the living environment and lifestyle for the elderly to prevent heat disorders
Scientific Title:Acronym
Measurement of thermal environments and physiological value of the elderly in summer
Region
| Japan |
Condition
Condition
heat disorders
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The thermal environment, physiological value under daily life environment are measured for the purpose to prevent heat disorders of elder person.
Corrective strategy is examined based on the measurement results and questionnaire survey.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
temperature/relative humidity / clo value / physical activity / skin temperature/
thermal sensation/thermal comfort/perspiration
Key secondary outcomes
lifestyle/air-conditioning/
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
universiry student
healthy older adults
Key exclusion criteria
Those who cannot cooperate in the continuous measurement for three days
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Michiyo |
| Middle name | |
| Last name | AZUMA |
Organization
Kio University
Division name
Faculty of Health Sciences
Zip code
635-0832
Address
4-2-2 Umami-naka Koryo-cho, Kitakatsuragi-gun,Nara,635-0832 Japan
TEL
+81-745-54-1601
m.azuma@kio.ac.jp
Public contact
Name of contact person
| 1st name | Hirotsugu |
| Middle name | |
| Last name | Nakayama |
Organization
Kio University
Division name
General affairs department
Zip code
635-0832
Address
4-2-2 Umami-naka Koryo-cho, Kitakatsuragi-gun,Nara,635-0832 Japan
TEL
+81-745-54-1601
Homepage URL
soumu@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kio University
Address
4-2-2 Umami-naka Koryo-cho, Kitakatsuragi-gun,Nara,635-0832 Japan
Tel
0745-54-1601
soumu@kio.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
| 2014 | Year | 10 | Month | 28 | Day |
Related information
URL releasing protocol
https://kaken.nii.ac.jp/ja/file/KAKENHI-PROJECT-24500934/24500934seika.pdf
Publication of results
Published
Result
URL related to results and publications
https://kaken.nii.ac.jp/ja/file/KAKENHI-PROJECT-24500934/24500934seika.pdf
Number of participants that the trial has enrolled
51
Results
Older adults were accepted hot environment in their daily lives and tended to wear a large amount of clothes. The changes of skin ambient was effected by ambient air temperature, indicating the importance of promoting appropriate environmental regulation behavior.
Results date posted
| 2021 | Year | 11 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healthy older adults
Participant flow
Recruitment of volunteers through the Silver Human Resources Center, etc.
Adverse events
nothing special
Outcome measures
ambient temperature and humidity
skin temperature
warm / cold threshold
Clo value
questionnaire
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2012 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2012 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All participants were healthy Japanese individuals living in the Kinki region of Japan.
The questionnaire survey contents were individual characteristics, knowledge about heat disorders, daily living habits, behavior related to environmental control, provisions for the summer heat, and water and food intake.
The measurement survey contents were the data on ambient air temperature, relative humidity, skin temperature, activity, thermal sensation, comfort sensations, room temperature evaluations, acceptability, and the clothing insulation (clo) value.
Management information
Registered date
| 2014 | Year | 10 | Month | 28 | Day |
Last modified on
| 2021 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009556
| 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 |
