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Los efectos del entrenamiento de las actividades de retoques en la flexibilidad cognitiva en adultos mayores de las comunidades

16 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Actual)

118

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

65 años y mayores (Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Ciencia básica
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Retocando

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.

Comparador activo: Control de retoques

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.

Comparador activo: Juegos de mesa

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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes of Event-related potential component (ERP): P2, N2, P3
Periodo de tiempo: Week 0, Week 12

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
Changes of reaction time and accuracy of task-switching paradigm
Periodo de tiempo: Week 0, Week 12

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
Changes of Accuracy in Wisconsin Card Sorting Test
Periodo de tiempo: Week 0, Week 12

Score ranged 0-128, the higher the score, the better the executive function

Week 0, Week 12
Changes of Number of Categories Completed in Wisconsin Card Sorting Test
Periodo de tiempo: Week 0, Week 12

The number of sequences of 10 consecutive correct matches (maximum = 6), higher the score, the better the executive function

Week 0, Week 12
Changes of Trials to Complete First Category in Wisconsin Card Sorting Test
Periodo de tiempo: Week 0, Week 12

Total number of trials to complete first category, the less the score, the better the executive function

Week 0, Week 12
Changes of Percent Perseverative Errors in Wisconsin Card Sorting Test
Periodo de tiempo: Week 0, Week 12

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
Changes of Failure to Maintain Set in Wisconsin Card Sorting Test
Periodo de tiempo: Week 0, Week 12

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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes of University of California, Los Angeles Loneliness Scale
Periodo de tiempo: Week 0, Week 12

score ranged 20-80, the higher the greater sense of loneliness in the participants.

Week 0, Week 12
Changes of Geriatric Depression Scale
Periodo de tiempo: Week 0, Week 12

Score ranged 0-15, the higher the score, the severe the depressive symptoms.

Week 0, Week 12
Changes of Flow Scale
Periodo de tiempo: Week 0, Week 12

Score ranged 1-5, higher the score, the better the flow experience the participant had.

Week 0, Week 12
Changes of Cognitive Flexibility Scale (CFS)
Periodo de tiempo: Week 0, Week 12

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
Changes of Guilford's Alternative Uses Test (GAU)
Periodo de tiempo: Week 0, Week 12

Scoring in terms of originality, fluency, elaboration and flexibility. The higher the score the better the creativity and divergent thinking.

Week 0, Week 12
Changes of Color Trails Test (CTT)
Periodo de tiempo: Week 0, Week 12

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
Changes of University of California, San Diego Performance-Based Skills Assessment (UPSA-BRIEF)
Periodo de tiempo: Week 0, Week 12

Score range 0-100, the higher the score, the better the function of activities of daily living.

Week 0, Week 12
Changes of Remote Associates Test
Periodo de tiempo: Week 0, Week 12

Score range 0-30. The higher the score, the better the ability of remote associate creativity.

Week 0, Week 12
Changes of Neural functional activity during inferential processing
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Change in Wechsler Memory Scale III Logical Memory I & II
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Week 0, Week 12

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

Week 0, Week 12

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Hui-Fen Mao, M.S., National Taiwan University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

22 de febrero de 2021

Finalización primaria (Actual)

29 de julio de 2024

Finalización del estudio (Actual)

29 de julio de 2024

Fechas de registro del estudio

Enviado por primera vez

6 de abril de 2022

Primero enviado que cumplió con los criterios de control de calidad

27 de abril de 2022

Publicado por primera vez (Actual)

3 de mayo de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

21 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

16 de septiembre de 2026

Última verificación

1 de diciembre de 2024

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 202010050RINB

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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

Marco de tiempo para compartir IPD

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.

Criterios de acceso compartido de IPD

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.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CÓDIGO_ANALÍTICO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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