Computerized Cognitive Training in Healthy Older Adults and Mild Cognitive Impairment
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Computerized Cognitive Training, Active Control Computerized Activities.
- Кому может быть актуально
- Состояния в реестре: Mild Cognitive Impairment (MCI), Healthy Aging. Базовые параметры: от 65 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Испания
- Следующий шаг
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Официальное название
Computerized Executive Function Training in Healthy Older Adults and Individuals With Mild Cognitive Impairment: Transfer Effects on Memory and Emotional Outcomes. A Randomized Controlled Trial
Обзор
The overall objective of this study is to assess the effect of an adaptive computerized cognitive training program for executive functions (CogniFit platform) on improving these functions in older adults, both healthy and with mild cognitive impairment (MCI), as well as to examine the potential transfer effects of this training on memory. Additionally, determine the impact of the intervention on the emotional symptoms, behavioral disorders, or quality of life of the participants.
Подробное описание
Population aging leads to an increase in the prevalence of cognitive decline, which negatively affects the autonomy and quality of life of older adults.
In turn, the mild cognitive impairment (MCI) is an intermediate state between normal aging and dementia. The impact of adaptive computerized cognitive training (CCT) specifically focused on executive functions in older adults with healthy cognition and MCI has not yet been sufficiently explored.
Additionally, the following stand out in both conditions: small sample sizes, limited duration, a lack of evidence regarding transfer effects to memory, insufficient knowledge of the actual impact on the emotional health, behavioral disorders, or quality of life, among other factors.
Among the main questions it aims to answer are:
* What are the initial differences in emotional symptoms (depression, anxiety), behavioral disorders, and quality of life between healthy older adults and adults with MCI, before the intervention? * Are there any improvements in emotional and functional well-being following the program intervention? * What are the effects of executive function training (adaptive CCT) on improving performance in executive functions? * Is there a transfer from trained executive functions to untrained memory domains directly?
Recruitment is carried out in day care centers and nursing homes that have shown collaboration with the university and have agreed to conduct the study. This recruitment takes place in Spain, in different autonomous communities.
Participants aged 65 years and older will be randomly assigned to one of four experimental conditions, defined by the combination of cognitive status (healthy aging vs. MCI) and type of intervention (training vs. active control). Accordingly, four experimental groups will be established.
Participants in this study will complete three in-person assessments: baseline (prior to cognitive training), post-intervention, and a three-month follow-up assessment. Each assessment session will last approximately two hours per participant. Assessments will be conducted by a multidisciplinary research team composed of psychologists, neuropsychologists, and neuroscientists with expertise in cognitive aging and cognitive interventions.
The intervention will last between 8 and 12 weeks, with participants completing approximately two to three training sessions per week. Training sessions will be conducted in small groups (approximately 3-5 participants) under the supervision of a psychologist from the research team, in designated rooms within each residence equipped with tables and tablets provided by the research team.
The executive function cognitive training program will be implemented using the CogniFit platform (CogniFit Inc ©) in research mode.
Вмешательства
- Поведенческое Computerized Cognitive Training
Participants in the experimental groups (Group 2: trained healthy individuals; Group 4: trained individuals with mild cognitive impairment) will use an online cognitive training platform (CogniFit®) consisting of multiple interactive games designed to train reasoning and executive functions. Training activities will target key executive processes related to reasoning, including processing speed, planning, working memory updating, focused attention, cognitive flexibility, and response inhibition. - Поведенческое Active Control Computerized Activities
Participants in the active control groups (Group 1: healthy control; Group 3: MCI control) will also use the CogniFit platform. However, in this condition, participants will engage in simple recreational computerized activities designed to control for screen exposure, participant engagement, and expectancy effects (e.g., digital coloring tasks, visual puzzles, and contour-tracing activities), without specifically targeting higher-order cognitive functions. Participants will complete sessions las
Первичные конечные точки
- Lobo's Mini Cognitive Examination (Spanish version of the MMSE) [Срок оценки: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).]
- CogniFit Cognitive Assessment Battery for Reasoning (CAB-RS) [Срок оценки: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).]
- CogniFit Cognitive Assessment Battery for Memory (CAB-ME) [Срок оценки: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).]
Вторичные конечные точки (7)
- Trail Making Test (Part A and Part B) [Срок оценки: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).]
- Digit Span Test (Modalities: Digital Span Forward and Digital Span Backward) [Срок оценки: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).]
- Yesavage Geriatric Depression Scale (Spanish adaptation) [Срок оценки: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).]
- Geriatric Anxiety Inventory (Spanish adaptation) [Срок оценки: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).]
- Neuropsychiatric Inventory Questionnaire (Spanish adaptation) [Срок оценки: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).]
- FUMAT Quality of Life Scale [Срок оценки: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).]
- Lawton & Brody Instrumental Activities of Daily Living Scale [Срок оценки: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).]
Критерии участия
Критерии включения
- adults 65 years of age and older;
- spanish speakers;
- residents in Spain (urban and rural communities);
- elderly population that does not have dementia or other major diagnosed uncontrolled neurological disorders;
- the initial cognitive state will be determined by a global screening test, the Lobo's Mini Cognitive Examination, that is, the spanish version of the Mini-Mental State Examination (MMSE); and 6) all participants must provide their signed written informed consent indicating that the individual has been informed of the relevant aspects of the study (and may withdraw from the study at any time if they so request).
Критерии исключения
- Older adults who obtain scores indicative of severe impairment (to be determined for low MEC scores that are suggestive of incipient dementia) or whose medical condition prevents them from participating safely;
- diagnosis of dementia (e.g., Alzheimer's disease or other);
- uncontrolled active major psychiatric illness (major depression, schizophrenia, etc.);
- significant uncontrolled neurological conditions or history (e.g., Parkinson's disease, stroke, severe traumatic brain injury);
- uncontrolled decompensated chronic medical conditions (e.g., diabetes, cardiovascular disease) that may affect cognition or attendance at sessions; and 6) severe uncorrected sensory disabilities (e.g., blindness or severe hearing loss) that interfere with the performance of tasks on tablets.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Испания · 2 центра
- Nebrija University — Madrid
- Complutense University of Madrid — Madrid
Идентификаторы
NCT: NCT07598409 · 57_CE_20251113_MOD