UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021463 |
|---|---|
| Receipt number | R000024752 |
| Scientific Title | Investigation of emotional assessment accompanying town-walk programs featuring radon in air as value-added regional resources |
| Date of disclosure of the study information | 2016/03/14 |
| Last modified on | 2017/07/18 11:47:34 |
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Basic information
Public title
Investigation of emotional assessment accompanying town-walk programs featuring radon in air as value-added regional resources
Acronym
Changes in saliva cortisol levels and emotional assessment after walking in Komono Town, Mie Prefecture
Scientific Title
Investigation of emotional assessment accompanying town-walk programs featuring radon in air as value-added regional resources
Scientific Title:Acronym
Changes in saliva cortisol levels and emotional assessment after walking in Komono Town, Mie Prefecture
Region
| Japan |
Condition
Condition
healthy subject
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, focusing on the effect of walking on relaxation, we compared levels of stress hormones and emotional scores obtained before and after walking.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary cortisol, Mood check list short form 2(MCL-S.2), and Visual analog scale(VAS) just before-and-after walking program as intervention
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
After giving their informed consent, local residents participated in two walking programs, each for a distance of approximately 7 km.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy male and female
Key exclusion criteria
Not have serious underlying disease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chihiro MIWA |
Organization
Aichi Medical College for Physical and Occupational Therapy
Division name
Department of rehabilitation
Zip code
Address
519 Ichiba, Kiyosu, Aichi
TEL
052-409-3311
aichi@yuai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasunori MORI |
Organization
Mie Prefecture Health and Environment Research Institute
Division name
Department of hygienic sciences
Zip code
Address
3684-11 Sakura-cho, Yokkaichi, Mie
TEL
059-329-3800
Homepage URL
hokan@pref.mie.jp
Sponsor or person
Institute
Mie Prefecture Health and Environment Research Institute
Institute
Department
Personal name
Funding Source
Organization
Mie Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 03 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
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 | 02 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 14 | Day |
Last modified on
| 2017 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024752
| 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 |
