NCT05359289

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 3, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

May 3, 2022

Status Verified

August 1, 2021

Enrollment Period

1.8 years

First QC Date

April 7, 2022

Last Update Submit

April 27, 2022

Conditions

Keywords

forest therapysuccessful ageingphysical and mental healthcognitive healthsenior fitnessclinic trialbrain imaging

Outcome Measures

Primary Outcomes (32)

  • 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.

    week 0, week 12

  • 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.

    week 0, week 12

  • 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.

    week 0, week 12

  • 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.

    week 0, week 12

  • 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.

    week 0, week 12

  • Change in Wechsler Memory Scale III Logical Memory I & II

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

    week 0, week 12

  • Change in Wechsler Memory Scale III Face Memory

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

    week 0, week 12

  • Change in Wechsler Memory Scale III Verbal Paired Memory

    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

    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

    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

    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

    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

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

    week 0, week 12

  • Change in Wechsler Adult Intelligence Scale III Vocabulary

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

    week 0, week 12

  • Change in Wechsler Adult Intelligence Scale III Digit Symbol

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

    week 0, week 12

  • Change in Wechsler Adult Intelligence Scale III Block Design

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

    week 0, week 12

  • Change in Wechsler Adult Intelligence Scale III Arithmetic

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

    week 0, week 12

  • Change in Wechsler Adult Intelligence Scale III Matrix Reasoning

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

    week 0, week 12

  • 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.

    week 0, week 12

  • 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.

    week 0, week 12

  • 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.

    week 0, week 12

  • 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.

    week 0, week 12

  • 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.

    week 0, week 12

  • 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.

    week 0, week 12

  • Change in Body Mass Index(BMI)

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

    week 0, week 12

  • Change in Waist-Hip Ratio

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

    week 0, week 12

  • Change in 30s arm curl test

    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

    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

    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

    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

    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

    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 Outcomes (1)

  • Changes of neural functional activity during resting-state

    week 0, week 12

Study Arms (3)

Forest therapy training

EXPERIMENTAL

Participants will expect to have an improvement of cognitive functions via a serial nature-based therapy/intervention.

Behavioral: Forest therapy training

Senior fitness training

ACTIVE COMPARATOR

Participants will expect to have an improvement of cognitive functions through a structural senior fitness program.

Behavioral: Senior fitness training

Board Games

PLACEBO COMPARATOR

Participants will play boards games under a schedule matching the Experimental and Active Comparator arms.

Behavioral: Board Games

Interventions

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

Forest therapy 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.

Senior fitness training
Board GamesBEHAVIORAL

Participants will play board games with each other.

Board Games

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

School of Forestry and Resource Conservation, National Taiwan University

Taipei, 10617, Taiwan

RECRUITING

National Taiwan Science Education Center

Taipei, 11165, Taiwan

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Chia-Pin Yu, Ph.D.

    National Taiwan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chia-Pin Yu, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2022

First Posted

May 3, 2022

Study Start

September 1, 2021

Primary Completion

July 1, 2023

Study Completion

July 1, 2024

Last Updated

May 3, 2022

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share

Data that can be shared include anonymized neuropsychological assessment scores, cognitive behavioral performance scores, brain imaging data that have been published.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
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.
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.

Locations