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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 11165
        • Recruiting
        • National Taiwan Science Education Center
        • Contact:
        • Sub-Investigator:
          • Chia-Pin Yu, Ph.D.
      • Taipei, Taiwan, 10617
        • Recruiting
        • School of Forestry and Resource Conservation, National Taiwan University
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Board Games
Participants will play boards games under a schedule matching the Experimental and Active Comparator arms.
Behavioral: Board Games
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.
Behavioral: Forest therapy training
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.
Behavioral: Senior fitness training
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Science and Technology, Taiwan
National Taiwan University
National Taiwan Science Education Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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