UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047628 |
|---|---|
| Receipt number | R000054313 |
| Scientific Title | Effects of Shinrin-yoku on endocrine system and cognitive reserve function: Randomized controlled study |
| Date of disclosure of the study information | 2022/06/01 |
| Last modified on | 2023/10/27 12:06:43 |
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Basic information
Public title
Study on Health Promotion by Shinrin-yoku
-Effects of Shinrin-yoku on the Endocrine System-
Acronym
Changes in endocrine by Shinrin-yoku
Scientific Title
Effects of Shinrin-yoku on endocrine system and cognitive reserve function: Randomized controlled study
Scientific Title:Acronym
Changes in endocrine 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 how the endocrine system is affected by Shinrin-yoku
Basic objectives2
Others
Basic objectives -Others
Examine whether Shinrin-yoku improves cognitive reserve function
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Increase in serotonin secretion by 5 hours of forest bathing, including a 5 km round-trip walk(compared to urban walking)
Key secondary outcomes
Increased oxytocin secretion and improved cognitive reserve function after 5 hours of forest bathing, including a 5 km round-trip walk(compared to urban walking)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Three-day stay in Nagano with overnight stay. The first group will walk in Akazawa Natural Recreation Forest on the first day and walk in the urban area of Ina City on the second day. The walk will last 5 hours, including a 5 km round trip walk.
Interventions/Control_2
Three-day stay in Nagano with overnight stay. The second group will walk in the urban area of Ina City on the first day and walk in Akazawa Natural Recreation Forest on the second day. The walk will last 5 hours, including a 5 km round trip 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
Female
Key inclusion criteria
1. The subject must be able to undertake a 4-hour walk without difficulty.
2. Reside in an urban area in the Kanto region.
Key exclusion criteria
1. Has depression, dementia, and various addictions.
2. Are taking medications (e.g., antidepressants) that may affect this study, and have a history of hospitalization or hospital visits related to these medications.
Target sample size
30
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
Nippon Medical School
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
| 2022 | Year | 06 | Month | 01 | 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
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 28 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 28 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 28 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 29 | 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=R000054313
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
