UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060745 |
|---|---|
| Receipt number | R000069510 |
| Scientific Title | Effects of Exercise and Nanomist Sauna Bathing on Cytokines, Physical Activity Levels, Circulation, Metabolism, Immune Function, and Psychological Health |
| Date of disclosure of the study information | 2026/02/25 |
| Last modified on | 2026/02/25 16:36:26 |
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Basic information
Public title
Effects of Exercise and Nanomist Sauna Bathing on Cytokines, Physical Activity Levels, Circulation, Metabolism, Immune Function, and Psychological Health
Acronym
Effects of Exercise and Nanomist Sauna Bathing on Cytokines, Physical Activity Levels, Circulation, Metabolism, Immune Function, and Psychological Health
Scientific Title
Effects of Exercise and Nanomist Sauna Bathing on Cytokines, Physical Activity Levels, Circulation, Metabolism, Immune Function, and Psychological Health
Scientific Title:Acronym
Effects of Exercise and Nanomist Sauna Bathing on Cytokines, Physical Activity Levels, Circulation, Metabolism, Immune Function, and Psychological Health
Region
| Japan |
Condition
Condition
Healthy participants
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to scientifically clarify the effects of nanomist saunas and exercise on physical activity levels, the cardiovascular system, metabolism, and psychological health, and to explore their potential application as physical therapy.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle-derived myokine (Irisin)
Key secondary outcomes
Blood test data, physical activity level, upper and lower limb muscle strength, walking ability, hair mineral analysis, pain, salivary immunoglobulin A, health-related QOL, anxiety, mood changes, sleep quality
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Be 18 years of age or older at the time of consent acquisition
2)Individuals using Shinobuyama Terrace
3)Individuals who have consented to participate in this research
Key exclusion criteria
1)Fever, bacterial infection, acute inflammatory disease, acute myocardial infarction, severe hypertension, pregnancy or menstruation, severe anemia, purpura (individuals with bleeding factors), undergoing dialysis
2)Being 85 years of age or older
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Endo |
Organization
Fukushima Medical University
Division name
Department of Physical Therapy
Zip code
960-8516
Address
10-6, Sakaemachi, Fukushima City, Japan
TEL
024-581-5539
ysendo@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Edno |
Organization
Fukushima Medical University
Division name
Department of Physical Therapy
Zip code
9608516
Address
10-6, Sakaemachi, Fukushima City, Japan
TEL
0245815539
Homepage URL
yasuendo18@gmail.com
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
kushima Medical University
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
Fukushima Medical University
Address
1 Hikariga-oka, Fukushima City 960-1295, JAPAN
Tel
024-547-1825
rs@fmu.ac.jp
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
福島県立医科大学（福島県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2035 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Participants will freely choose to use either the nano mist sauna, exercise, or both as part of their regular facility use at Shinobuyama Terrace.
Primary and secondary outcome measures will be assessed at baseline, 1 month, 2 months, and 3 months.
Management information
Registered date
| 2026 | Year | 02 | Month | 25 | Day |
Last modified on
| 2026 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069510
