The Training Effects of Tinkering Activities on Cognitive Flexibility in Older Adults From Communities

January 19, 2025 updated by: National Taiwan University Hospital
Aging has been a serious global-wise concern in public health. In particular, elders face declination of cognitive functions that threaten their quality of life. A good approach to slow down cognitive declination during aging processes is therefore in urgent need. According to the Successful Aging model (Rowe, J.W. and Kahn, R.L) participation in meaningful occupational activity may maintains high cognitive and body function. This sub-project is a part of the larger integrated project that will address the need for cognitive promotion by conducting cognitive training interventions on community older adults, utilizing the National Taiwan Science Education Center (NTSEC) as the public recruiting site as well as intervention site. In this sub-project, a 12-week intervention will be carried out with three protocols: 1) Tinkering activities, 2)Controlled Tinkering Activities, and 3) Board Game intervention. Board games serve as a commonly seen cognitive training, with a growing series of literature continuing to support board games being the medium of cognitive promotion. Tinkering activities are primarily used in fields of education that comprise science, art, and technology. Through a series of themes objectives, participants can involve interestingly, creatively, and flexibly in the activity when the participants fulfill the goal with the materials retrievable at the site. The anticipation is that the elders participating in Tinkering activities may increase their cognitive flexibility as the participants involve in the elements hidden within the core of the training, such as problem exploration, active thinking and inference, trial and error, and problem-solving. The investigators target to obtain pre-and post-intervention behavioral and neurophysiological data, including electroencephalogram data in 40 experimental participants, 40 active control participants, and 40 passive control participants over a period of 3 years.

Study Overview

Study Type

Interventional

Enrollment (Actual)

118

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 Locations

      • Taipei, Taiwan, 10051
        • College of Medicine, National Taiwan University
      • Taipei, Taiwan, 11165
        • National Taiwan Science Education Center

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

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.
  • Severe impairment of visual or auditory abilities.
  • Diagnosed with mild cognitive impairment (MCI), or Dementia
  • Severe psychological or behavioral disorder that would seriously interfere with the progress of activity
  • History of degenerative cognitive disorder (e.g., acute stroke, traumatic brain injury, unconscious), organic mental disorders, brain dysfunction, or other neurology-related diagnoses.

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
Experimental: Tinkering
Tinkering activities are activities that comprise elements of science, art, and technology. Through a series of themes objectives, participants can involve interestingly, creatively, and flexibly in the activity when they fulfill the goal with the materials retrievable at the site. Participants will be trained as they involve in the elements hidden within the core of the training, such as problem exploration, active thinking and inference, trial and error, and problem-solving.
Active Comparator: Control Tinkering
Controlled Tinkering Activities utilize the themes of Tinkering activities but eliminate the core of Tinkering training, hence implementing a new set of activities that emphasize participants strictly follow procedures to complete the similar objective of Tinkering activities. Each participant will end up with a similar piece of work as Tinkering Activities participants would without problem exploration, active thinking and inference, trial and error, and problem-solving.
Active Comparator: Board Games
Board games are often constructed with concepts of different cognitive components, such as attention, working memory, planning, calculation; therefore serve as a commonly seen cognitive training, while more and more literature continues to support tabletop games being the medium of cognitive promotion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of Event-related potential component (ERP): P2, N2, P3
Time Frame: Week 0, Week 12, Week 36
The EEG data is recorded while the participants are carrying out the task-switching paradigm. The data will then be analyzed in terms of Event-Related Potential(ERP), where the components' changes will be observed in terms of amplitude and latency.
Week 0, Week 12, Week 36
Changes of reaction time and accuracy of task-switching paradigm
Time Frame: Week 0, Week 12, Week 36
The task-switching paradigm will ask the participants to judge whether the number(stimulus) presented is 1) even or odd, OR, 2) more than or less than 5. The switching between these rules will induce a switch cost effect (the time when the rule changes, the reaction time will increase to compensate the cognitive process needed to make the change) if the reaction time decreases after intervention, it implies an improvement.
Week 0, Week 12, Week 36
Changes of Accuracy in Wisconsin Card Sorting Test
Time Frame: Week 0, Week 12, Week 36
Score ranged 0-128, the higher the score, the better the executive function
Week 0, Week 12, Week 36
Changes of Number of Categories Completed in Wisconsin Card Sorting Test
Time Frame: Week 0, Week 12, Week 36
The number of sequences of 10 consecutive correct matches (maximum = 6), higher the score, the better the executive function
Week 0, Week 12, Week 36
Changes of Trials to Complete First Category in Wisconsin Card Sorting Test
Time Frame: Week 0, Week 12, Week 36
Total number of trials to complete first category, the less the score, the better the executive function
Week 0, Week 12, Week 36
Changes of Percent Perseverative Errors in Wisconsin Card Sorting Test
Time Frame: Week 0, Week 12, Week 36
The concentration of perseverative errors in relation to overall test performance (the number of trials given) multiplied by 100. The less the score, the better the executive function.
Week 0, Week 12, Week 36
Changes of Failure to Maintain Set in Wisconsin Card Sorting Test
Time Frame: Week 0, Week 12, Week 36
When a participant makes five or more consecutive correct matches but then makes an error before successfully completing the category, the less the score, the better the executive function.
Week 0, Week 12, Week 36

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Changes of University of California, Los Angeles Loneliness Scale
Time Frame: Week 0, Week 12, Week 36
score ranged 20-80, the higher the greater sense of loneliness in the participants.
Week 0, Week 12, Week 36
Changes of Geriatric Depression Scale
Time Frame: Week 0, Week 12, Week 36
Score ranged 0-15, the higher the score, the severe the depressive symptoms.
Week 0, Week 12, Week 36
Changes of Flow Scale
Time Frame: Week 0, Week 12, Week 36
Score ranged 1-5, higher the score, the better the flow experience the participant had.
Week 0, Week 12, Week 36
Changes of Cognitive Flexibility Scale (CFS)
Time Frame: Week 0, Week 12, Week 36
It is a 12-item 6-point scale in Likert format, the higher the score, the higher the participants' cognitive flexibility.
Week 0, Week 12, Week 36
Changes of Guilford's Alternative Uses Test (GAU)
Time Frame: Week 0, Week 12, Week 36
Scoring in terms of originality, fluency, elaboration and flexibility. The higher the score the better the creativity and divergent thinking.
Week 0, Week 12, Week 36
Changes of Color Trails Test (CTT)
Time Frame: Week 0, Week 12, Week 36
Measures in time, error, cues, near miss, and color error. The less time, error, cues, near miss and color error the participants take, the better the executive function, alternate and sustain attention.
Week 0, Week 12, Week 36
Changes of University of California, San Diego Performance-Based Skills Assessment (UPSA-BRIEF)
Time Frame: Week 0, Week 12, Week 36
Score range 0-100, the higher the score, the better the function of activities of daily living.
Week 0, Week 12, Week 36
Changes of Remote Associates Test
Time Frame: Week 0, Week 12, Week 36
Score range 0-30. The higher the score, the better the ability of remote associate creativity.
Week 0, Week 12, Week 36
Changes of Neural functional activity during inferential processing
Time Frame: Week 0, Week 12
Participants will undergo a Rule Inference functional magnetic resonance imaging 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 functional magnetic resonance imaging 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 functional magnetic resonance imaging 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 functional magnetic resonance imaging task will be assessed.
Week 0, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hui-Fen Mao, M.S., 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)

February 22, 2021

Primary Completion (Actual)

July 29, 2024

Study Completion (Actual)

July 29, 2024

Study Registration Dates

First Submitted

April 6, 2022

First Submitted That Met QC Criteria

April 27, 2022

First Posted (Actual)

May 3, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 19, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 202010050RINB

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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