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Recruiting Not applicable

Effects of a Computerized Cognitive Stimulation Intervention Adapted to the Level of Cognitive Reserve

NCT06279325 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2024-04-01
Last updated
2024-12-12

Condition(s) studied

Mild Cognitive ImpairmentCognitive Dysfunction

Investigational drug(s) / intervention(s)

Computerized cognitive stimulation programFace-to-face training-explanatory session

Computerized cognitive stimulation program: * The cognitive stimulation (CS) program, for the IG, will be previously designed by 2 Occupational Therapy (OT) of the team, and adapted to the computerized format through a platform specialized in cognitive neurorehabilitation. The activities will be designed under OT models: human occupation model and cognitive-perceptual model, so that the different professions, interests and roles are represented, and allow to express different levels of complexity, according to the level of Cognitive Reserve (CR). * The cognitive aspects to be worked on are: memory, orientation, language, praxis, gnosis, calculation, perception, logical reasoning, attention-concentration and executive functions. * In addition, reinforcement, EF, episodic memory, attention and information processing speed activities will be designed, also according to the CR level.

Face-to-face training-explanatory session: The CG will undergo a group and face-to-face training-explanatory session, where the importance of maintaining the usual level of cognitive activity will be emphasized.

Study summary

Normal ageing presents subtle cognitive changes that can be detected before meeting the criteria for Mild cognitive impairment (MCI). Older people with low cognitive reserve and who receive limited cognitive stimulation are at greater risk of deterioration. In this regard, cognitive stimulation (CS) has been identified as an intervention that reduces this risk, provided that its design considers the differences in the level of cognitive reserve (CR) acquired throughout life and the baseline level of cognitive functioning. The general objective of this study is to evaluate, through a randomized clinical trial, the effectiveness of a computerized cognitive stimulation program, designed and adapted from Occupational Therapy based on the level of cognitive reserve in older adults in Primary Care. 100 participants will be randomized in a stratified manner according to the level of cognitive reserve (high/low), assigning 50 participants to the control group and 50 participants to the intervention group. The intervention group will carry out a computerized cognitive stimulation intervention designed and adapted from occupational therapy according to the level of cognitive reserve, through the "stimulus" platform. The main result expected to be achieved is the improvement of higher brain functions. As secondary results, the investigators expect that those cognitive aspects most vulnerable to ageing will decrease more slowly (in areas such as memory, executive function, attention and processing speed) and that the cognitive reserve of the participants will increase, in addition to being able to balance gender differences in these aspects. The investigators think that these results can positively impact the creation of adapted, meaningful and stimulating CS programs in older adults to prevent MCI and experience healthier ageing.

Eligibility

Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Age: ≥ 60 years. * With score in Lobo's Mini-cognitive Examination (MEC-35) (Lobo, A., Escolar, V., Ezquerra, J., \& Seva Díaz, 1979) between: 28-35 points (Friedman et al., 2012; Vinyoles Bargalló et al., 2002). * Non-institutionalized persons, belonging to the health centers where the study was conducted. * With a minimum educational level (knowing how to read and write). * Who do not present hearing, visual or communication difficulties that would prevent them from completing the cognitive training. Exclusion Criteria: * People with mild cognitive impairment or Alzheimer's disease (AD). * People with significant functional impairment. * People who have received any type of professionalized cognitive stimulation therapy in the last year. * People with significant psychiatric conditions, such as major depressive disorder or schizophrenia. * People who are taking medications that may adversely affect cognitive function, such as anticholinergics, tranquilizers and anticonvulsants.

Primary outcome measure(s)

  • MEC-35 (Spanish version of Folstein's Mini-Mental) — An initial evaluation (pre), post-intervention (in a period of 2 to 7 days after the last intervention session) and two follow-up evaluations (at 6 and 12 months) will be carried out.
    The primary outcome variable is MEC-35 (Spanish version of Folstein's Mini-Mental): the most widely used cognitive test in Primary Care, adapted by Lobo to the Spanish population (Lobo, A., et al 1979). It evaluates 8 components: temporal orientation, spatial orientation, fixation memory, attention, calculation, short-term memory, language and praxis. Its sensitivity is 85-90% and its specificity 69% (Lobo, A. et al 1999). Although its cut-off point for detecting cognitive impairment is 24, in NC, scores between 28-35 points are considered (Friedman et al., 2012; Vinyoles Bargalló et al., 2002).
  • Cognitive Reserve Questionnaire (CRQ) — An initial evaluation (pre), post-intervention (in a period of 2 to 7 days after the last intervention session) and two follow-up evaluations (at 6 and 12 months) will be carried out.
    To determine the level of cognitive reserve (Landenberger et al., 2019) the most suitable questionnaire is the Cognitive Reserve Questionnaire (CRQ) (Rami et al., 2011). It has eight items with between three and six response options. Each item relieves a CR factor: schooling, parental schooling, courses, occupation, musical training, languages, reading and intellectual games. The maximum score is 25 points. Between 7 and 9 points is considered a medium-low range of CR. Between 10-14 points medium-high range, and ≥15 points, high CR. It is an instrument with high reliability and acceptable convergent validity (Martino et al., 2021).

Trial sites (1)

FacilityCityRegionStatus
Centro de Salud Arrabal Zaragoza Zaragoza Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06279325 on ClinicalTrials.gov ↗ ← All trials in Spain