UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of emotional assessment accompanying town-walk programs featuring radon in air as value-added regional resources
Title of the study (Brief title)	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	Chihiro MIWA
Organization	Aichi Medical College for Physical and Occupational Therapy
Division name	Department of rehabilitation
Address	519 Ichiba, Kiyosu, Aichi
TEL	052-409-3311
Email	aichi@yuai.ac.jp

Public contact
Name of contact person	Yasunori MORI
Organization	Mie Prefecture Health and Environment Research Institute
Division name	Department of hygienic sciences
Address	3684-11 Sakura-cho, Yokkaichi, Mie
TEL	059-329-3800
Homepage URL
Email	hokan@pref.mie.jp

Sponsor
Institute	Mie Prefecture Health and Environment Research Institute
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024752