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

NCT05358145 | Completed

• 1 other identifier: 202010050RINB
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cognitive Training

Keywords

Task-Switching; Electroencephalogram; Cognitive Flexibility; Aging; Brain Imaging

Outcome Measures

Primary Outcomes (7)

• Changes of Event-related potential component (ERP): P2, N2, P3

  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

  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

  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

  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

  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

  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

  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 Outcomes (25)

• Changes of University of California, Los Angeles Loneliness Scale

  Week 0, Week 12, Week 36

• Changes of Geriatric Depression Scale

  Week 0, Week 12, Week 36

• Changes of Flow Scale

  Week 0, Week 12, Week 36

• Changes of Cognitive Flexibility Scale (CFS)

  Week 0, Week 12, Week 36

• Changes of Guilford's Alternative Uses Test (GAU)

  Week 0, Week 12, Week 36

Study Arms (3)

Tinkering

EXPERIMENTAL

Behavioral: Tinkering Activities

Control Tinkering

ACTIVE COMPARATOR

Behavioral: Control Tinkering Activities

Board Games

ACTIVE COMPARATOR

Behavioral: Board Games Activities

Interventions

Tinkering Activities BEHAVIORAL

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.

Tinkering

Control Tinkering Activities BEHAVIORAL

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.

Control Tinkering

Board Games Activities BEHAVIORAL

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.

Board Games

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older 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.
• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator
• National Taiwan University: collaborator
• National Taiwan Science Education Center: collaborator

Study Sites (2)

College of Medicine, National Taiwan University

Taipei, 10051, Taiwan

Location

National Taiwan Science Education Center

Taipei, 11165, Taiwan

Location

Study Officials

• Hui-Fen Mao, M.S.

  National Taiwan University

  PRINCIPAL INVESTIGATOR

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 6, 2022
• First Posted: May 3, 2022
• Study Start: February 22, 2021
• Primary Completion: July 29, 2024
• Study Completion: July 29, 2024
• Last Updated: January 22, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• 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

TW (2)