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Forest Therapy for CognitionNCT05359289

Effects of Forest Therapy on Cognitive Performance and Mental Health in Older Adults Health in Older Adults

A study testing Forest therapy training, Senior fitness training and Board Games in people with Forest Therapy for Cognition, run by National Taiwan University Hospital at 2 sites in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Forest Therapy for Cognition
What is being tested?
Forest therapy training, Senior fitness training and Board Games
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
2 sitesTaiwan
Study dates
1 Sep 2021to Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Literate in Mandarin and Taiwanese.
  • Willing to participate entirely in this research.
  • Age > 65.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Chia-Pin Yu, Ph.D. contact

+886 2 33664618

simonyu@ntu.edu.tw

Taiwan2 sites, 2 recruiting
  • School of Forestry and Resource Conservation, National Taiwan University

    Taipei, 10617

    Chia-Pin Yu, Ph.D., +886 2 33664618, simonyu@ntu.edu.tw

    Recruiting
  • National Taiwan Science Education Center

    Taipei, 11165

    Carmen Lui, B. Sc, +886-2-6610-1234, luicarmen21@gmail.com

    Chia-Pin Yu, Ph.D.

    Recruiting

Other trials in Taiwan

About this study

Official title: 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.

Read the 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.

Being tested
Forest therapy training, Senior fitness training, Board Games
Keywords
forest therapy, successful ageing, physical and mental health, cognitive health, senior fitness, clinic trial, brain imaging
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Forest therapy trainingBehavioural

    Participants will experience nature-based interventions including forest hiking, horticultural therapy and green wellness activities for their mental health and physical conditions.

  • Senior fitness trainingBehavioural

    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.

  • Board GamesBehavioural

    Participants will play board games with each other.

Study groups in NCT05359289
Study groupRoleWhat they receive
Forest therapy trainingExperimentalParticipants will expect to have an improvement of cognitive functions via a serial nature-based therapy/intervention.
Receives: Behavioral: Forest therapy training
Senior fitness trainingActive comparatorParticipants will expect to have an improvement of cognitive functions through a structural senior fitness program.
Receives: Behavioral: Senior fitness training
Board GamesPlacebo comparatorParticipants will play boards games under a schedule matching the Experimental and Active Comparator arms.
Receives: Behavioral: Board Games

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes of neural functional activity during inferential processing

    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.

    Measured: week 0, week 12

  2. Changes of overall accuracy during inferential processing

    Changes from pre- to post-intervention in participant overall accuracy in identifying latent rules in the Rule Inference fMRI task.

    Measured: week 0, week 12

  3. Changes of learning rate during inferential processing

    Changes from pre- to post-intervention in participant number of trials to criterion in the Rule Inference fMRI task.

    Measured: week 0, week 12

  4. Changes of strategic performance during inferential processing

    Changes from pre- to post-intervention in participant coefficients of expression of modeled response strategies in the Rule Inference fMRI task will be assessed.

    Measured: week 0, week 12

  5. Changes in the Montreal Cognitive Assessment (MoCA) score

    Pre- to post-intervention changes in participant MoCA score. Score range from 0 to 30 with higher scores indicating better cognitive ability.

    Measured: week 0, week 12

  6. Change in Wechsler Memory Scale III Logical Memory I & II

    Score range 0 - 75. Higher score indicates better verbal episodic memory.

    Measured: week 0, week 12

  7. Change in Wechsler Memory Scale III Face Memory

    Score range 0 - 48. Higher score indicates better visual face memory.

    Measured: week 0, week 12

  8. Change in Wechsler Memory Scale III Verbal Paired Memory

    Score range 0 - 32. Higher score indicates better verbal memory and learning.

    Measured: week 0, week 12

  9. Change in Wechsler Memory Scale III Family Pictures I & II

    Score range 0 - 64. Higher score indicates better visual memory and learning.

    Measured: week 0, week 12

  10. Change in Wechsler Memory Scale III Word Lists I & II

    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.

    Measured: week 0, week 12

  11. Change in Wechsler Memory Scale III Visual Reproduction I & II

    Score range 0 - 104. Higher score indicates better visual memory. For II, recall score range is 0-104; recognition score range is 0-48.

    Measured: week 0, week 12

  12. Change in Wechsler Memory Scale III Spatial Span

    Score range 0 - 32. Higher score indicates better spatial memory. range is 0-48.

    Measured: week 0, week 12

  13. Change in Wechsler Memory Scale III Digit Span

    Score range 0 - 32. Higher score indicates better auditory memory.

    Measured: week 0, week 12

  14. Change in Wechsler Adult Intelligence Scale III Vocabulary

    Score range 0 - 66. Higher score indicates better vocabulary.

    Measured: week 0, week 12

  15. Change in Wechsler Adult Intelligence Scale III Digit Symbol

    Score range 0 - 133. Higher score indicates better processing speed.

    Measured: week 0, week 12

  16. Change in Wechsler Adult Intelligence Scale III Block Design

    Score range 0 - 68. Higher score indicates better visual processing.

    Measured: week 0, week 12

  17. Change in Wechsler Adult Intelligence Scale III Arithmetic

    Score range 0 - 22. Higher score indicates better mathematical computation ability.

    Measured: week 0, week 12

  18. Change in Wechsler Adult Intelligence Scale III Matrix Reasoning

    Score range 0 - 26. Higher score indicates better reasoning.

    Measured: week 0, week 12

  19. Change in the Profile of Mood States(POMS)

    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.

    Measured: week 0, week 12

  20. Change in State-Trait Anxiety Inventory(STAI)

    Pre- to post-intervention changes in participant STAI score. Score range from 0 to 80 with higher scores indicating higher anxiety level.

    Measured: week 0, week 12

  21. Change in Chinese Word Remote Associate Task(CWRAT)

    Pre- to post-intervention changes in participant CWRAT score. Score range from 0 to 80 with higher scores indicating better creativity.

    Measured: week 0, week 12

  22. Change in Diastolic Blood Pressure(DBP) and Systolic Blood Pressure(SBP)

    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.

    Measured: week 0, week 12

  23. Change in heart rate

    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.

    Measured: week 0, week 12

  24. Change in heart rate variability (HRV)

    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.

    Measured: week 0, week 12

  25. Change in Body Mass Index(BMI)

    Changes from pre- to post-intervention in participant Body Mass Index.

    Measured: week 0, week 12

  26. Change in Waist-Hip Ratio

    Changes from pre- to post-intervention in participant Waist-Hip Ratio.

    Measured: week 0, week 12

  27. Change in 30s arm curl test

    Changes from pre- to post-intervention in participant 30s arm curl test, with higher times indicating better strength.

    Measured: week 0, week 12

  28. Change in 30s chair stand test

    Changes from pre- to post-intervention in participant 30s chair stand test, with higher times indicating better endurance.

    Measured: week 0, week 12

  29. Change in back scratch test

    Changes from pre- to post-intervention in participant 30s back scratch test, with higher times indicating better upper limb flexibility.

    Measured: week 0, week 12

  30. Change in chair sit-and-reach test

    Changes from pre- to post-intervention in participant 30s chair sit-and-reach test, with higher times indicating better lower limb flexibility.

    Measured: week 0, week 12

  31. Change in Seated Up- and- Go Test

    Changes from pre- to post-intervention in participant Seated Up- and- Go Test, with fewer time indicating better dynamic balance and agility.

    Measured: week 0, week 12

  32. Change in 2-minute step test

    Changes from pre- to post-intervention in participant Seated Up- and- Go Test, with higher times indicating better cardiorespiratory fitness.

    Measured: week 0, week 12

Secondary outcomes (1)
  1. Changes of neural functional activity during resting-state

    Brain functional activity measured using fMRI during rest with eyes-open

    Measured: week 0, week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2022
  2. Study start1 Sep 2021
  3. Primary completionJul 2023 (estimated)
  4. Study completionJul 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05359289
Sponsor's protocol ID
202105HM079
Status last verified
Aug 2021
First submitted
7 Apr 2022
Last updated
3 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data that can be shared include anonymized neuropsychological assessment scores, cognitive behavioral performance scores, brain imaging data that have been published.

Questions about this trial

What is this clinical trial studying?

A study testing Forest therapy training, Senior fitness training and Board Games in people with Forest Therapy for Cognition, run by National Taiwan University Hospital at 2 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chia-Pin Yu, Ph.D. (+886 2 33664618, simonyu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes of neural functional activity during inferential processing (time frame: week 0, week 12). The study lists 32 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022.

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