UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033018
Receipt No. R000037643
Scientific Title Relationship of various diseases with daily bathing at home and hot spa bathing by middle-aged and elderly ambulatory patients: a Japanese multicenter cross-sectional study
Date of disclosure of the study information 2018/06/16
Last modified on 2019/02/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Relationship of various diseases with daily bathing at home and hot spa bathing by middle-aged and elderly ambulatory patients: a Japanese multicenter cross-sectional study
Acronym Relationship between bathing and various diseases
Scientific Title Relationship of various diseases with daily bathing at home and hot spa bathing by middle-aged and elderly ambulatory patients: a Japanese multicenter cross-sectional study
Scientific Title:Acronym Relationship between bathing and various diseases
Region
Japan

Condition
Condition Various diseases
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the relationship between daily and hot spa bathing and the number of underlying diseases in middle-aged and elderly ambulatory patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Occurrence of underlying diseases.
We identified the underlying diseases based on two sources. First was the International Statistical Classification of Diseases and Related Health Problems (ICD-11). The following chapters in ICD-11 were referenced: Chapter 2, Neoplasms; Chapter 4, Diseases of the blood or blood-forming organs; Chapter 5, Endocrine, nutrition, or metabolic diseases; Chapter 6, Mental, behavioural or neurodevelopmental disorders; Chapter 8, Diseases of the nervous system; Chapter 11, Diseases of the circulatory system; Chapter 12, Diseases of the respiratory system; Chapter 13, Diseases of the digestive system; Chapter 14, Diseases of the skin; and Chapter 15, Diseases of the musculoskeletal system or connective tissue. The second source was a book entitled Balneology, Climatology and Physical Medicine (in Japanese) published by the Japanese Society of Balneology, Climatology and Physical Medicine in 2014. From this source, we adopted the section "Medical treatment for specific diseases".
Key secondary outcomes

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
85 years-old >=
Gender Male and Female
Key inclusion criteria The participants in this study are ambulatory patients aged 60-85 years are being treated by certified medical doctors of the Japanese Society Balneology, Climatology and Physical Medicine during October 1-7, 2018.
Key exclusion criteria Nothing.
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroharu Kamioka
Organization Tokyo Unversity of Agriculture
Division name Faculty of Regional Environment Science
Zip code
Address Sakuragaoka 1-1-1, Setagayaku, Tokyo, Japan
TEL 03-5477-2587
Email h1kamiok@nodai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takamitsu Uchiyama
Organization Tokyo University of Agriculture
Division name Research Institute
Zip code
Address Sakuragaoka 1-1-1, Setagayaku, Tokyo, Japan
TEL 03-5477-2532
Homepage URL
Email uchiyama@nodai.ac.jp

Sponsor
Institute Academic Committee, Japanese Society of Balneology, Climatology and Physical Medicine
Institute
Department

Funding Source
Organization Japanese Society of Balneology, Climatology and Physical Medicine
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
Address
Tel
Email

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
2018 Year 06 Month 16 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://doi.org/10.1016/j.ctim.2019.02.003
Number of participants that the trial has enrolled
Results
Among the 1,261 patients who participated, there was no significant difference in age between males (n=508, 72.8yrs.) and females (n=753, 73.5yrs.). There was also no significant age difference between males (number of diseases: 2.7pts.) and females (number of diseases: 2.7pts.) in the occurrence of underlying diseases. Frequency and time of daily hot water bathing at home were not associated with the occurrence of underlying diseases. However, compared with participants who utilized hot water spa at least once a week, the occurrence of underlying diseases was significantly associated with bathing frequency: one to three times per month (OR 2.72, 95% CI: 1.63-4.52); twice or five times a year (OR 1.92, 95% CI: 1.25-2.94). 
       In conclusion, lower frequency of hot water spa bathing was significantly associated with increased risk on the occurrence of underlying diseases in middle-aged and elderly ambulatory patients. 
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
2018 Year 06 Month 16 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
2018 Year 10 Month 07 Day
Date of closure to data entry
2018 Year 10 Month 20 Day
Date trial data considered complete
2018 Year 10 Month 25 Day
Date analysis concluded
2018 Year 11 Month 20 Day

Other
Other related information Authors and Contributors: Prof. Hiroharu Kamioka, Dr. Yasunori Mori, Dr. Katsutaro Nagata, Dr. Shigeaki Iwanaga, Prof. Masahiko Uzura, Dr. Satoru Yamaguchi. HK (steering author) conceive the study. YM will perform the statistical analyses. KN, SI, MU, and SY confirmed medical items on the check sheet.
The exposure group in this study is ambulatory patients aged 60-85 years are being treated by certified medical doctors of the Japanese Society Balneology, Climatology and Physical Medicine during October 1-7, 2018. Frequency and time if daily bathing and hot spa bathing is recorded for these patients, along with the occurrence of underlying diseases. Finding from the exposure group are compared with those from a low frequency-bathing group and a short time-bathing group. The methodology of this study was approved by the Ethics Board of Tokyo University of Agriculture (No.1809).

Management information
Registered date
2018 Year 06 Month 16 Day
Last modified on
2019 Year 02 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037643

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.