UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033018 |
|---|---|
| Receipt number | 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 08:05:19 |
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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
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
uchiyama@nodai.ac.jp
Sponsor or person
Institute
Academic Committee, Japanese Society of Balneology, Climatology and Physical Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037643
| Research Plan | |
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