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

Cognitive Training Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05358145
• Other study ID #: 202010050RINB
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2021
• Est. completion date: July 2024

Study information

• Verified date: November 2023
• Source: National Taiwan University Hospital
• Contact: Hui-Fen Mao, M.S.
• Phone: 02-3366-8178
• Email: huifen02[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Training

Intervention

Behavioral:
• Tinkering Activities
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.
• Control Tinkering Activities
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.
• Board Games Activities
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.

Locations

Country	Name	City	State
Taiwan	College of Medicine, National Taiwan University	Taipei
Taiwan	National Taiwan Science Education Center	Taipei

Sponsors (4)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Ministry of Science and Technology, Taiwan, National Taiwan Science Education Center, National Taiwan University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Changes of University of California, Los Angeles Loneliness Scale	score ranged 20-80, the higher the greater sense of loneliness in the participants.	Week 0, Week 12, Week 36
Secondary	Changes of Geriatric Depression Scale	Score ranged 0-15, the higher the score, the severe the depressive symptoms.	Week 0, Week 12, Week 36
Secondary	Changes of Flow Scale	Score ranged 1-5, higher the score, the better the flow experience the participant had.	Week 0, Week 12, Week 36
Secondary	Changes of Cognitive Flexibility Scale (CFS)	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
Secondary	Changes of Guilford's Alternative Uses Test (GAU)	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
Secondary	Changes of Color Trails Test (CTT)	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
Secondary	Changes of University of California, San Diego Performance-Based Skills Assessment (UPSA-BRIEF)	Score range 0-100, the higher the score, the better the function of activities of daily living.	Week 0, Week 12, Week 36
Secondary	Changes of Remote Associates Test	Score range 0-30. The higher the score, the better the ability of remote associate creativity.	Week 0, Week 12, Week 36
Secondary	Changes of Neural functional activity during inferential processing	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
Secondary	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 functional magnetic resonance imaging task.	Week 0, Week 12
Secondary	Changes of learning rate during inferential processing	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
Secondary	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 functional magnetic resonance imaging task will be assessed.	Week 0, Week 12
Secondary	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
Secondary	Change in Wechsler Memory Scale III Face Memory	Score range 0 - 48. Higher score indicates better visual face memory.	Week 0, Week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Wechsler Memory Scale III Spatial Span	Score range 0 - 32. Higher score indicates better spatial memory.	Week 0, Week 12
Secondary	Change in Wechsler Memory Scale III Digit Span	Score range 0 - 32. Higher score indicates better auditory memory.	Week 0, Week 12
Secondary	Change in Wechsler Adult Intelligence Scale III Vocabulary	Score range 0 - 66. Higher score indicates better vocabulary.	Week 0, Week 12
Secondary	Change in Wechsler Adult Intelligence Scale III Digit Symbol	Score range 0 - 133. Higher score indicates better processing speed.	Week 0, Week 12
Secondary	Change in Wechsler Adult Intelligence Scale III Block Design	Score range 0 - 68. Higher score indicates better visual processing.	Week 0, Week 12
Secondary	Change in Wechsler Adult Intelligence Scale III Arithmetic	Score range 0 - 22. Higher score indicates better mathematical computation ability.	Week 0, Week 12
Secondary	Change in Wechsler Adult Intelligence Scale III Matrix Reasoning	Score range 0 - 26. Higher score indicates better reasoning.	Week 0, Week 12