- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05359289
Effects of Forest Therapy on Cognitive Performance and Mental Health in Older Adults Health in Older Adults
April 27, 2022 updated by: National Taiwan University Hospital
Effects of Forest Therapy on Cognitive Performance and Mental Health in Older Adults
In Taiwan, aging is happening at a fast pace.
The Taiwan Ministry of Interior officially announced that Taiwan will become an aged society in April 2018 and is expected to transition into a hyper-aged society within eight years.
Critically, scholars recognize that optimizing cognitive activity and wellbeing influences quality of life in a late life which in turn is a key factor for successful aging.
To alleviate the social and economic impact of aging, as well as impact on families, there is a need for studying anti-aging approaches.
The World Health Organization suggests that the general public should have a healthy lifestyle which includes participating in activities for physical health, as well as cognitive and mental health involving maintaining social interactions.
This present research is part of a broader integrated program in which the purpose is to promote and study the efficacy of forest therapy on physical health, and cognitive and mental health in older adults.
The study site is located at the National Taiwan Science Education Center (NTSEC) which includes wetlands, waterfronts, green-spaces and urban parks.
The investigators will evaluate two types of interventions for participants, "forest therapy program" and "fitness program" for older adults.
The study approach applies a between-subjects and pretest-posttest design.
The investigators will collect participants' physical data, psychological responses, and cognitive performance in the course of both programs.
By comparing these data before and after the intervention programs, the investigators seek to understand the both programs' effects on physical health, and cognitive and mental health.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
In Taiwan, aging is happening at a fast pace.
The Taiwan Ministry of Interior officially announced that Taiwan will become an aged society in April 2018 and is expected to transition into a hyper-aged society within eight years.
Critically, scholars recognize that optimizing cognitive activity and wellbeing influences quality of life in a late life which in turn is a key factor for successful aging.
To alleviate the social and economic impact of aging, as well as impact on families, there is a need for studying anti-aging approaches.
The World Health Organization suggests that the general public should have a healthy lifestyle which includes participating in activities for physical health, as well as cognitive and mental health involving maintaining social interactions.
This present research is part of a broader integrated program in which the purpose is to promote and study the efficacy of forest therapy on physical health, and cognitive and mental health in older adults.
The study site is located at the National Taiwan Science Education Center (NTSEC) which includes wetlands, waterfronts, green-spaces and urban parks.
The investigators will evaluate two types of interventions for participants, "forest therapy program" and "fitness program" for older adults.
The study approach applies a between-subjects and pretest-posttest design.
The investigators will collect participants' physical data, psychological responses, and cognitive performance in the course of both programs.
By comparing these data before and after the intervention programs, the investigators seek to understand the both programs' effects on physical health, and cognitive and mental health.
In addition, the investigators will elucidate the efficacy of the forest therapy program through measurement of the changes in physical, cognitive, and mental health performance and status indicators.
The forest therapy and fitness programs at National Taiwan Science Education Center (NTSEC), along with a robot programming training and tinkering activities that are part of the broader project, acts as a public education and service window towards addressing cognitive aging issues in Taiwan.
It should be further noted that this will be a critical platform for obtaining ecological research data on a novel class of cognitive interventions for cognitive aging using psychological and brain imaging techniques to bridge critical neural mechanistic knowledge gaps.
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chia-Pin Yu, Ph.D.
- Phone Number: +886 2 33664618
- Email: simonyu@ntu.edu.tw
Study Locations
-
-
-
Taipei, Taiwan, 11165
- Recruiting
- National Taiwan Science Education Center
-
Contact:
- Carmen Lui, B. Sc
- Phone Number: +886-2-6610-1234
- Email: luicarmen21@gmail.com
-
Sub-Investigator:
- Chia-Pin Yu, Ph.D.
-
Taipei, Taiwan, 10617
- Recruiting
- School of Forestry and Resource Conservation, National Taiwan University
-
Contact:
- Chia-Pin Yu, Ph.D.
- Phone Number: +886 2 33664618
- Email: simonyu@ntu.edu.tw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Literate in Mandarin and Taiwanese.
- Willing to participate entirely in this research.
- Age > 65.
Exclusion Criteria:
- Participated in cognitive-related training in the past two months.
- Diagnosed with mild cognitive impairment(MCI)
- Severe psychological or behavioral disorder that would seriously interfere with the progress of activity.
- Severe hearing Impairments or visual Impairment
- History of degenerative cognitive disorders, Organic Mental Disorders, Brain Dysfunction, Psychogenic neurosis.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Board Games
Participants will play boards games under a schedule matching the Experimental and Active Comparator arms.
|
Participants will play board games with each other.
|
|
Experimental: Forest therapy training
Participants will expect to have an improvement of cognitive functions via a serial nature-based therapy/intervention.
|
Participants will experience nature-based interventions including forest hiking, horticultural therapy and green wellness activities for their mental health and physical conditions.
|
|
Active Comparator: Senior fitness training
Participants will expect to have an improvement of cognitive functions through a structural senior fitness program.
|
The fitness program includes physics fitness of stamina, coordination and aerobic exercise in 12 weeks.
Participants will join the senior fitness program including physical fitness, aerobic exercise and exercise prescription during the 12 weeks program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes of neural functional activity during inferential processing
Time Frame: week 0, week 12
|
Participants will undergo a Rule Inference fMRI task to infer underlying rules that map color configurations of circles in a triangular arrangement to a target color category within as few tries as possible under active or passive conditions.The goal for participants will be to infer the cue-category association rules using as few cues as possible.
The primary outcome measure here is the degree of neural response estimate change in blood oxygen level dependent (BOLD)signal pre- and post-intervention.
|
week 0, week 12
|
|
Changes of overall accuracy during inferential processing
Time Frame: week 0, week 12
|
Changes from pre- to post-intervention in participant overall accuracy in identifying latent rules in the Rule Inference fMRI task.
|
week 0, week 12
|
|
Changes of learning rate during inferential processing
Time Frame: week 0, week 12
|
Changes from pre- to post-intervention in participant number of trials to criterion in the Rule Inference fMRI task.
|
week 0, week 12
|
|
Changes of strategic performance during inferential processing
Time Frame: week 0, week 12
|
Changes from pre- to post-intervention in participant coefficients of expression of modeled response strategies in the Rule Inference fMRI task will be assessed.
|
week 0, week 12
|
|
Changes in the Montreal Cognitive Assessment (MoCA) score
Time Frame: week 0, week 12
|
Pre- to post-intervention changes in participant MoCA score.
Score range from 0 to 30 with higher scores indicating better cognitive ability.
|
week 0, week 12
|
|
Change in Wechsler Memory Scale III Logical Memory I & II
Time Frame: week 0, week 12
|
Score range 0 - 75.
Higher score indicates better verbal episodic memory.
|
week 0, week 12
|
|
Change in Wechsler Memory Scale III Face Memory
Time Frame: week 0, week 12
|
Score range 0 - 48.
Higher score indicates better visual face memory.
|
week 0, week 12
|
|
Change in Wechsler Memory Scale III Verbal Paired Memory
Time Frame: week 0, week 12
|
Score range 0 - 32.
Higher score indicates better verbal memory and learning.
|
week 0, week 12
|
|
Change in Wechsler Memory Scale III Family Pictures I & II
Time Frame: week 0, week 12
|
Score range 0 - 64.
Higher score indicates better visual memory and learning.
|
week 0, week 12
|
|
Change in Wechsler Memory Scale III Word Lists I & II
Time Frame: week 0, week 12
|
Score range 0 - 36.
Higher score indicates better verbal memory and learning.
For II, recall score range is 0 to 8; recognition score range is 0 to 24.
|
week 0, week 12
|
|
Change in Wechsler Memory Scale III Visual Reproduction I & II
Time Frame: week 0, week 12
|
Score range 0 - 104.
Higher score indicates better visual memory.
For II, recall score range is 0-104; recognition score range is 0-48.
|
week 0, week 12
|
|
Change in Wechsler Memory Scale III Spatial Span
Time Frame: week 0, week 12
|
Score range 0 - 32.
Higher score indicates better spatial memory.
range is 0-48.
|
week 0, week 12
|
|
Change in Wechsler Memory Scale III Digit Span
Time Frame: week 0, week 12
|
Score range 0 - 32.
Higher score indicates better auditory memory.
|
week 0, week 12
|
|
Change in Wechsler Adult Intelligence Scale III Vocabulary
Time Frame: week 0, week 12
|
Score range 0 - 66. Higher score indicates better vocabulary.
|
week 0, week 12
|
|
Change in Wechsler Adult Intelligence Scale III Digit Symbol
Time Frame: week 0, week 12
|
Score range 0 - 133.
Higher score indicates better processing speed.
|
week 0, week 12
|
|
Change in Wechsler Adult Intelligence Scale III Block Design
Time Frame: week 0, week 12
|
Score range 0 - 68.
Higher score indicates better visual processing.
|
week 0, week 12
|
|
Change in Wechsler Adult Intelligence Scale III Arithmetic
Time Frame: week 0, week 12
|
Score range 0 - 22. Higher score indicates better mathematical computation ability.
|
week 0, week 12
|
|
Change in Wechsler Adult Intelligence Scale III Matrix Reasoning
Time Frame: week 0, week 12
|
Score range 0 - 26.
Higher score indicates better reasoning.
|
week 0, week 12
|
|
Change in the Profile of Mood States(POMS)
Time Frame: week 0, week 12
|
Pre- to post-intervention changes in participant POMS score.
Score range from 0 to 24 with higher scores indicating the level of each mood States, as tension-anxiety, anger-hostility, depression-dejection, fatigue-inertia, confusion-bewilderment, vigor-activity.
|
week 0, week 12
|
|
Change in State-Trait Anxiety Inventory(STAI)
Time Frame: week 0, week 12
|
Pre- to post-intervention changes in participant STAI score.
Score range from 0 to 80 with higher scores indicating higher anxiety level.
|
week 0, week 12
|
|
Change in Chinese Word Remote Associate Task(CWRAT)
Time Frame: week 0, week 12
|
Pre- to post-intervention changes in participant CWRAT score.
Score range from 0 to 80 with higher scores indicating better creativity.
|
week 0, week 12
|
|
Change in Diastolic Blood Pressure(DBP) and Systolic Blood Pressure(SBP)
Time Frame: week 0, week 12
|
Pre- to post-intervention changes in participant blood pressure.
Normal SBP of an adult under 120 mmHg and normal DBP under 80 mmHg with lower pressure indicating better health.
|
week 0, week 12
|
|
Change in heart rate
Time Frame: week 0, week 12
|
Pre- to post-intervention changes in participant heart rate.
The normal heart rate of an adult beats between 60 to 100 times per minute, with lower times indicating better health.
|
week 0, week 12
|
|
Change in heart rate variability (HRV)
Time Frame: week 0, week 12
|
Changes from pre- to post-intervention in participant HRV.
In sympathetic nervous system, with lower ratio of Low/High Frequency and higher high Frequency indicating better relaxation.
|
week 0, week 12
|
|
Change in Body Mass Index(BMI)
Time Frame: week 0, week 12
|
Changes from pre- to post-intervention in participant Body Mass Index.
|
week 0, week 12
|
|
Change in Waist-Hip Ratio
Time Frame: week 0, week 12
|
Changes from pre- to post-intervention in participant Waist-Hip Ratio.
|
week 0, week 12
|
|
Change in 30s arm curl test
Time Frame: week 0, week 12
|
Changes from pre- to post-intervention in participant 30s arm curl test, with higher times indicating better strength.
|
week 0, week 12
|
|
Change in 30s chair stand test
Time Frame: week 0, week 12
|
Changes from pre- to post-intervention in participant 30s chair stand test, with higher times indicating better endurance.
|
week 0, week 12
|
|
Change in back scratch test
Time Frame: week 0, week 12
|
Changes from pre- to post-intervention in participant 30s back scratch test, with higher times indicating better upper limb flexibility.
|
week 0, week 12
|
|
Change in chair sit-and-reach test
Time Frame: week 0, week 12
|
Changes from pre- to post-intervention in participant 30s chair sit-and-reach test, with higher times indicating better lower limb flexibility.
|
week 0, week 12
|
|
Change in Seated Up- and- Go Test
Time Frame: week 0, week 12
|
Changes from pre- to post-intervention in participant Seated Up- and- Go Test, with fewer time indicating better dynamic balance and agility.
|
week 0, week 12
|
|
Change in 2-minute step test
Time Frame: week 0, week 12
|
Changes from pre- to post-intervention in participant Seated Up- and- Go Test, with higher times indicating better cardiorespiratory fitness.
|
week 0, week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes of neural functional activity during resting-state
Time Frame: week 0, week 12
|
Brain functional activity measured using fMRI during rest with eyes-open
|
week 0, week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Chia-Pin Yu, Ph.D., National Taiwan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2021
Primary Completion (Anticipated)
July 1, 2023
Study Completion (Anticipated)
July 1, 2024
Study Registration Dates
First Submitted
April 7, 2022
First Submitted That Met QC Criteria
April 27, 2022
First Posted (Actual)
May 3, 2022
Study Record Updates
Last Update Posted (Actual)
May 3, 2022
Last Update Submitted That Met QC Criteria
April 27, 2022
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 202105HM079
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data that can be shared include anonymized neuropsychological assessment scores, cognitive behavioral performance scores, brain imaging data that have been published.
IPD Sharing Time Frame
Data will become available 1 year after primary results are published by the central research team.
Data are anticipated to be available for sharing for an indefinite period after the above criteria is met.
IPD Sharing Access Criteria
Data sharing will be done based direct requests and on case-by-case evaluation for appropriateness.
Use of shared data will require agreement on appropriate citation of data sources at least or authorship inclusion or acknowledgement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Forest Therapy for Cognition
-
University of VigoPlan social EnceCompletedMood | Autonomic Nervous System Activity | Healthy Subjects (HS) | Forest TherapySpain
-
National University Hospital, SingaporeUnknownIndications for Warfarin TherapySingapore, Malaysia
-
Al-Azhar UniversityNot yet recruitingPrimary Teeth Indicated for Pulp Therapy
-
NHS Greater Glasgow and ClydeUniversity of GlasgowCompletedPatients Referred for Routine Psychological TherapyUnited Kingdom
-
Biotronik SE & Co. KGCompleted
-
EBG MedAustron GmbHRecruiting
-
Northwestern UniversityUniversity of PennsylvaniaCompletedAssess Fidelity to Cognitive-behavioral Therapy for Youth
-
Second Affiliated Hospital, School of Medicine,...Not yet recruitingHELICOBACTER PYLORI INFECTIONS | Rescue Therapy for Helicobacter Pylori
-
PfizerTerminatedInfant, Small for Gestational Age | Growth Hormone TherapyGermany
-
Ankara City Hospital BilkentCompletedCognition | Geriatric Patients | Sedation for Gastroenteric Endoscopic ProcedureTurkey
Clinical Trials on Board Games
-
Riphah International UniversityCompletedGeriatric PopulationPakistan
-
National University of SingaporeAWWA Rehab and Day Care CentreCompleted
-
University of CalgaryNational Alliance for Research on Schizophrenia and DepressionCompletedProdromal Schizophrenia
-
National Taiwan University HospitalMinistry of Science and Technology, Taiwan; National Taiwan University; National...CompletedCognitive TrainingTaiwan
-
National Taiwan University HospitalRecruitingPromoting Active Inference of Healthy Older Adults With Language ActivityTaiwan
-
Brain In Game scientific-technical serviceAtención, Familia, Infancia, Mayores (AFIM21); Mercurio DistribucionesCompletedCognitive Change | Child DevelopmentSpain
-
Brain In Game scientific-technical serviceUniversity Hospital of Santa Maria, LleidaRecruitingCognitive Impairment, MildSpain
-
National Taiwan University HospitalMinistry of Science and Technology, Taiwan; National Taiwan University; National...CompletedCognitive Inferential AbilityTaiwan
-
Bern University of Applied SciencesGoethe University; Maastricht University Medical Center; Swiss Federal Institute...CompletedMuscle Weakness | Poor Performance StatusSwitzerland
-
Geisinger ClinicCompletedRadiation Exposure to OperatorUnited States