UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062728 |
|---|---|
| Receipt number | R000071818 |
| Scientific Title | Evaluation of the effects of forest walking and digital biomarker measurement using a proprietary wearable device on mind and body. |
| Date of disclosure of the study information | 2026/09/04 |
| Last modified on | 2026/08/28 18:49:25 |
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Basic information
Public title
Evaluation of the effects of forest walking and digital biomarker measurement using a proprietary wearable device on mind and body.
Acronym
Evaluation of the effects of forest walking and digital biomarker
Scientific Title
Evaluation of the effects of forest walking and digital biomarker measurement using a proprietary wearable device on mind and body.
Scientific Title:Acronym
Evaluation of the effects of forest walking and digital biomarker
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
While recent advancements in science and technology and shifts in socio-economic structures have supported our convenient and fast-paced lifestyles, these rapid changes have also precipitated environmental issues (particularly climate change), exacerbated social inequality, and increased mental stress in daily life, thereby threatening human health and quality of life. Against this backdrop, there is growing expectation that utilizing environments such as forests and parks can improve psychological and physiological health, aid recovery from fatigue, and extend healthy life expectancy. Research is expanding globally, particularly regarding walking in forests and parks, to examine not only the physical health benefits of aerobic exercise but also the mental relaxation effects provided by the natural environment. This study conducts an exploratory assessment of physiological and psychological changes before and after walking in existing forest parks within Akita Prefecture, an area where scientific evidence-based research is currently lacking. The study utilizes physiological data measured via wearable devices developed at Akita International University, alongside psychological analysis (such as stress levels) derived from the State-Trait Anxiety Inventory (STAI) questionnaire.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary endpoint: The following item corresponding to the study objective of "objectively evaluating the physiological effects of walking in a forest park":
"Autonomic nervous system activity index (heart rate variability [HRV] analysis via precise fingertip measurement)"
Key secondary outcomes
Secondary endpoints: The following items established to complement the primary endpoint and to examine psychological effects and relationships with covariates from multiple perspectives.
1. Psychological endpoints: Changes in STAI (State-Trait Anxiety Inventory) scores (pre-walk vs. post-walk).
2. Other physiological endpoints: Comparison of resting heart rate (HR) and blood pressure/pulse wave-related indices at three time points.
3. Composite/exploratory endpoints: Correlation between physiological changes (change in HRV) and psychological changes (change in STAI); evaluation of the influence of environmental factors (weather, temperature, humidity) and baseline characteristics (age, gender, etc.).
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy men and women aged 18 or older who do not meet any exclusion criteria.
Key exclusion criteria
1) Exclusion criteria: Individuals who-based on an interview conducted using the explanatory document at the time of the participation request-present with skin conditions at the intended device attachment site; are pregnant or potentially pregnant; or have underlying medical conditions such as severe heart disease, malignant tumors, or active inflammation.
2) Individuals who have already been selected for and participated in another intervention group (forest park walk) in this study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Akitoshi |
| Middle name | |
| Last name | Seiyama |
Organization
Akita Inter
Division name
Creative Design and Data Science Center
Zip code
010-1292
Address
Yuwa, Akita City, 010-1292, Akita, japan
TEL
+81-18-886-5985
aseiyama@aiu.ac.jp
Public contact
Name of contact person
| 1st name | Akitoshi |
| Middle name | |
| Last name | SEIYAMA |
Organization
Akita International University
Division name
Creative Design and Data Science Center
Zip code
010-1292
Address
Yuwa, Akita City, 010-1292, Akita, japan
TEL
+81-18-886-5985
Homepage URL
aseiyama@aiu.ac.jp
Sponsor or person
Institute
Akita International University
Institute
Department
Personal name
Funding Source
Organization
Akita International 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
Akita International University
Address
Yuwa, Akita City, 010-1292, Akita, japan
Tel
+81-18-886-5985
aseiyama@aiu.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None in particular.
Management information
Registered date
| 2026 | Year | 08 | Month | 28 | Day |
Last modified on
| 2026 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071818
