UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045851 |
|---|---|
| Receipt number | R000051543 |
| Scientific Title | Effects of Shinrin-yoku on mucosal immunity: Randomized controlled study |
| Date of disclosure of the study information | 2021/10/25 |
| Last modified on | 2023/10/27 12:05:55 |
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Basic information
Public title
Study on Health Promotion by Shinrin-yoku - Effects of Shinrin-yoku on Immune System and Relationship with Endocrine System
Acronym
Changes in immune function by Shinrin-yoku
Scientific Title
Effects of Shinrin-yoku on mucosal immunity: Randomized controlled study
Scientific Title:Acronym
Changes in mucosal immune function by Shinrin-yoku: Randomized Controlled Study
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine whether performing Shinrin-yoku improves mucosal immune function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in sIgA levels after 2.5 hours of Shinrin-yoku, including 60 minutes of walking
Key secondary outcomes
Changes in NK cell activity, cytokines such as IgG and CD-8, and stress hormones such as cortisol before and after 2.5 hours of Shinrin-yoku, including 60 minutes of walking in the forest and city
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Two and a half hours of Shinrin-yoku, including a 60-minute walk (spend time in the forest using all five senses while taking a slow stroll).
Interventions/Control_2
The control group will perform the same activity in the city (2.5 hours in the city, including a 60-minute walk).
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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male
Key inclusion criteria
No difficulty walking for about 90 minutes.
The participants live in an urban area in the Kanto region and are able to travel to Ginza and Musashi Itsukaichi Station on their own without difficulty.
Key exclusion criteria
Those who are taking drugs such as antibiotics, anti-inflammatory drugs, anti-allergic drugs, steroids, immunosuppressive drugs, etc., which may affect this study. Those who have related diseases (collagen diseases, common cold, inflammatory diseases, etc.), and those who currently have a smoking habit.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hiroko |
| Middle name | |
| Last name | Ochiai |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Department of Plastic and Reconstructive Surgery
Zip code
152-8902
Address
2-5-1, Higashigaoka, Meguroku ,Tokyo
TEL
0334110111
ochiroko@gmail.com
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Ochiai |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Department of Plastic and Reconstructive Surgery
Zip code
152-8902
Address
2-5-1, Higashigaoka, Meguroku ,Tokyo
TEL
0334110111
Homepage URL
ochiroko@gmail.com
Sponsor or person
Institute
National Hospital Organization (Tokyo Medical Center Clinical Research Center)
Institute
Department
Personal name
Funding Source
Organization
The Commemorative Foundation for the Public Interest Fund for Vehicle Racing
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokyo Women's Medical University
Tokyo Medical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Tokyo Medical Center
Address
2-5-1, Higashigaoka, Meguroku ,Tokyo
Tel
0334110111
ochiroko@gmail.com
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
| 2021 | Year | 10 | 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
79
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
It is currently being submitted to a journal and has not yet been accepted for publication.
Date of the first journal publication of results
Baseline Characteristics
A:40-70-year-old men,B.no difficulty in walking for approximately 90 minutes, and C:living in an urban area in the Kanto region and being able to travel to place where the experiments are conducted on their own without difficulty. The exclusion criteria were as follows: a:those who were taking drugs such as antibiotics, anti-inflammatory drugs, anti-allergic drugs, steroids, immunosuppressive drugs, etc., which may affect this study; b:those who had related　diseases (collagen diseases, common cold, inflammatory diseases, etc.); and :those who had a smoking habit.
Participant flow
The 84 participants were randomized into two groups, 42 into the forest walk and 42 into the urban walk group. Due to scheduling problems and knee pain, withdrawals occurred, and 37 forest walkers and 41 urban walkers participated in the experiment. Saliva and blood samples were collected before and after each 90-minute walk, and questionnaires were administered.
Adverse events
Non ie particular.
Outcome measures
The primary outcome measure was salivary sIgA, and secondary outcomes included stress hormone levels, and the Profile of Mood Status questionnaire, second version (POMS-2).
Plan to share IPD
None in particular.
IPD sharing Plan description
None in particular.
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 25 | Day |
Last modified on
| 2023 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051543
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