Effects of a Computerised Cognitive Stimulation Versus Stimulating Leisure Activities

NCT06058611 | Recruiting

• 1 other identifier: U
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate, at the level of global cognition, cognitive neuroconstructs, memory, verbal fluency, ADLs, IADLs, symptoms of depression and anxiety, the effectiveness of a personalised and adapted computerised cognitive stimulation programme (GI1) implemented from Primary Care versus stimulating leisure activities (GI2), in older adults aged 50 years and over with mild cognitive impairment and subjective cognitive impairment living in the community.

Conditions

Mild Cognitive Impairment; Randomized Controlled Trial; Subjective Cognitive Impairment

Keywords

Mild Cognitive Impairment; Older adults; Elderly; Randomized Controlled Trial; Cognitive Stimulation; Cognitive Intervention; Cognitively Stimulating Leisure Activities; Leisure Activities; Subjective Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Lobo Cognitive Mini-Test (MEC-35)

  The MEC-35 is one of the most widely used short cognitive tests for the study of cognitive abilities in the primary care setting. The MEC-35 assesses eight cognitive functions: temporal and spatial orientation (10 items), fixation memory (3 items), attention (3 items), calculation (5 items), short-term memory (3 items) and language and praxis (11 items) (Lobo et al. 1999) (figure 1). Its sensitivity is 89.8% and its specificity 83.9% (Calero MD, Navarro E, Robles P, 2000). Unlike the MMSE, the MEC-35 includes a series of three digits to repeat two similar items in reverse order. Subtraction is performed 3 by 3 from 30, instead of 7 by 7 from 100 (Folstein et al., 1975).

  Post-intervention (1 week), 3 months, 6 months, 12 months

Secondary Outcomes (1)

• Test of Memory Alteration (T@M)

  Post-intervention (1 week), 3 months, 6 months, 12 months

Other Outcomes (5)

• Set-Test (S-T)

  Post-intervention (1 week), 3 months, 6 months, 12 months

• Activities of Daily Living Questionnaire T-ADLQ

  Post-intervention (1 week), 3 months, 6 months, 12 months

• Lawton and Brody scale (L-B)

  Post-intervention (1 week), 3 months, 6 months, 12 months

Study Arms (3)

Intervention group 1 (GI1)

EXPERIMENTAL

Intervention group 1 (IG1) will carry out personalised and adapted computerised cognitive stimulation (CE) through the stimulus platform; 30 minutes/day, 5 days/week, 8 weeks; 40 sessions. The following will be worked on: memory, orientation, language, praxis, gnosis, calculation, perception, logical reasoning, attention-concentration and executive functions.

Other: Cognitive stimulation

Intervention group 2 (GI2)

EXPERIMENTAL

Intervention group 2 (IG2) will perform between 2 and 5 cognitively stimulating leisure activities for 8 weeks. These leisure activities will be selected from the adapted version of the Karp et al. 2006 questionnaire (Karp et al., 2006) taking into account the three components of leisure activities (mental, physical and social). The questionnaire contains 29 activities. In addition to indicating which cognitively stimulating leisure activities they perform on a weekly basis, participants in IG2 will indicate their daily frequency (\< 30 min, 30min-1 hour, 1-2 hours, \> 2 hours), commenting on whether they have carried them out individually or in a group. It will also be taken into account whether these activities were previously carried out according to their stage of life.

Other: Stimulating leisure activities

Control Group (CG)

NO INTERVENTION

The control group (CG) will not receive any intervention during the study period.

Interventions

Cognitive stimulation OTHER

Cognitive stimulation through the stimulus platform; 30 minutes/day, 5 days/week, 8 weeks; 40 sessions. The following will be worked on: memory, orientation, language, praxis, gnosis, calculation, perception, logical reasoning, attention-concentration and executive functions.

Intervention group 1 (GI1)

Stimulating leisure activities OTHER

Intervention group 2 (IG2) will perform between 2 and 5 cognitively stimulating leisure activities for 8 weeks. These leisure activities will be selected from the adapted version of the Karp et al. 2006 questionnaire (Karp et al., 2006) taking into account the three components of leisure activities (mental, physical and social). The questionnaire contains 29 activities. In addition to indicating which cognitively stimulating leisure activities they perform on a weekly basis, participants in IG2 will indicate their daily frequency (\< 30 min, 30min-1 hour, 1-2 hours, \> 2 hours), commenting on whether they have carried them out individually or in a group. It will also be taken into account whether these activities were previously carried out according to their stage of life.

Intervention group 2 (GI2)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 50 years old, resident in the community.
• Diagnosis of MCI or having between 24 and 27 points on the MEC-35 (this score seems to indicate the presence of MCI) (Calero, M. D and Navarro, 2006).
• Subjective cognitive impairment (score between 28-31 points on the MEC-35) (Gómez-Soria et al. 2023)

You may not qualify if:

• Institutionalisation.
• Taking acetylcholinesterase inhibitors as they may act on global cognition and/or cognitive functions.
• Sensory deficits (deafness and blindness) preventing intervention.
• Agitation.
• Having received cognitive stimulation in the last 12 months.

Sponsors & Collaborators

• Universidad de Zaragoza: lead

Study Sites (1)

Centro de Salud Arrabal

Zaragoza, Zaragoza, 50015, Spain

RECRUITING

Related Publications (11)

• Lobo A, Saz P, Marcos G, Dia JL, de la Camara C, Ventura T, Morales Asin F, Fernando Pascual L, Montanes JA, Aznar S. [Revalidation and standardization of the cognition mini-exam (first Spanish version of the Mini-Mental Status Examination) in the general geriatric population]. Med Clin (Barc). 1999 Jun 5;112(20):767-74. Spanish.

  PMID: 10422057 BACKGROUND

• Calero MD, Navarro E, Robles P, Garcia-Berben TM. [[Validity of the Cognitive Mini-Exam of Lobo et al. for the detection of dementia-associated cognitive deterioration] ]. Neurologia. 2000 Oct;15(8):337-42. Spanish.

  PMID: 11143500 BACKGROUND

• Rami L, Bosch B, Valls-Pedret C, Caprile C, Sanchez-Valle Diaz R, Molinuevo JL. [Discriminatory validity and association of the mini-mental test (MMSE) and the memory alteration test (M@T) with a neuropsychological battery in patients with amnestic mild cognitive impairment and Alzheimer's disease]. Rev Neurol. 2009 Aug 16-31;49(4):169-74. Spanish.

  PMID: 19621317 BACKGROUND

• Carnero-Pardo C, Espejo-Martinez B, Lopez-Alcalde S, Espinosa-Garcia M, Saez-Zea C, Hernandez-Torres E, Navarro-Espigares JL, Vilchez-Carrillo R. Diagnostic accuracy, effectiveness and cost for cognitive impairment and dementia screening of three short cognitive tests applicable to illiterates. PLoS One. 2011;6(11):e27069. doi: 10.1371/journal.pone.0027069. Epub 2011 Nov 2.

  PMID: 22073256 BACKGROUND

• Pascual Millan LF, Martinez Quinones JV, Modrego Pardo P, Mostacero Miguel E, Lopez del Val J, Morales Asin F. [The set-test for diagnosis of dementia]. Neurologia. 1990 Mar;5(3):82-5. Spanish.

  PMID: 2361045 BACKGROUND

• Munoz-Neira C, Lopez OL, Riveros R, Nunez-Huasaf J, Flores P, Slachevsky A. The technology - activities of daily living questionnaire: a version with a technology-related subscale. Dement Geriatr Cogn Disord. 2012;33(6):361-71. doi: 10.1159/000338606. Epub 2012 Jul 11.

  PMID: 22797087 BACKGROUND

• Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, Bouter LM, de Vet HC. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007 Jan;60(1):34-42. doi: 10.1016/j.jclinepi.2006.03.012. Epub 2006 Aug 24.

  PMID: 17161752 BACKGROUND

• Pfeffer RI, Kurosaki TT, Harrah CH Jr, Chance JM, Filos S. Measurement of functional activities in older adults in the community. J Gerontol. 1982 May;37(3):323-9. doi: 10.1093/geronj/37.3.323.

  PMID: 7069156 BACKGROUND

• Marc LG, Raue PJ, Bruce ML. Screening performance of the 15-item geriatric depression scale in a diverse elderly home care population. Am J Geriatr Psychiatry. 2008 Nov;16(11):914-21. doi: 10.1097/JGP.0b013e318186bd67.

  PMID: 18978252 BACKGROUND

• Goldberg D, Bridges K, Duncan-Jones P, Grayson D. Detecting anxiety and depression in general medical settings. BMJ. 1988 Oct 8;297(6653):897-9. doi: 10.1136/bmj.297.6653.897.

  PMID: 3140969 BACKGROUND

• Karp A, Paillard-Borg S, Wang HX, Silverstein M, Winblad B, Fratiglioni L. Mental, physical and social components in leisure activities equally contribute to decrease dementia risk. Dement Geriatr Cogn Disord. 2006;21(2):65-73. doi: 10.1159/000089919. Epub 2005 Nov 23.

  PMID: 16319455 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The professionals responsible for the assessments will be blinded and will be different from the professionals carrying out the intervention. Both will be trained.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor doctor

Model Details: Parallel allocation Two intervention group (GI1 and GI2) and a control group (CG) with the same characteristics are included

Study Record Dates

• First Submitted: September 16, 2023
• First Posted: September 28, 2023
• Study Start: April 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: September 30, 2025
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)