UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The psychosomatic stress-associated effects of spa-resort tour in elderly people.
Title of the study (Brief title)	Psychosomatic stress and spa-bathing of the elderly
Region	Japan

Condition
Condition	None
Classification by specialty	Medicine in general Geriatrics Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the impact of a short-term spa-resort tour on psychosomatic stress of the elderly
Basic objectives2	Others
Basic objectives -Others	The evaluation of biological effects
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Stress score questionnaire
Key secondary outcomes	Blood pressure Salivary amylase Blood test (CRP, serum cortisol)

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	60 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy people aged 60 years or over
Key exclusion criteria	People in unhealthy condition
Target sample size	20

Research contact person
Name of lead principal investigator	Toyoki Maeda
Organization	Kyushu University Beppu Hospital
Division name	The division of internal medicine
Address	4546 Tsurumihara, Beppu, Oita, 874-0838, JAPAN
TEL	0977-27-1635(+81-977-27-1635)
Email	maedat@beppu.kyushu-u.ac.jp

Public contact
Name of contact person	Toyoki Maeda
Organization	Kyushu University Beppu Hospital
Division name	The division of internal medicine
Address	4546 Tsurumihara, Beppu, Oita, 874-0838, JAPAN
TEL	0977-27-1635(+81-977-27-1635)
Homepage URL
Email	maedat@beppu.kyushu-u.ac.jp

Sponsor
Institute	Beppu city
Institute
Department

Funding Source
Organization	Beppu city
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	2019 Year 06 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 30 Day
Anticipated trial start date	2017 Year 07 Month 03 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	Unpublished
URL releasing results
Results
Other related information	It was suggested that spa-resort tour was able to reduce psychosomatic stress of the participants.

Management information
Registered date	2019 Year 01 Month 09 Day
Last modified on	2019 Year 01 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040442