Effects of a Computerised Cognitive Stimulation Versus Stimulating Leisure Activities
NCT ID: NCT06058611
Last Updated: 2024-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2024-04-01
2025-09-30
Brief Summary
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Detailed Description
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Intervention Intervention group 1 (IG1) will carry out personalised and adapted computerised 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. Stimulus is a CE platform, which allows individualised intervention through the use of ICTs with different populations.
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 \[1) reading, 2) arts and crafts, 3) crosswords and word search puzzles, 4) interest in politics, 5) playing cards or chess, 6) visiting the second home, 7) attending courses, 8) watching television, 9) going to the theatre or concerts, 10) playing sports, 11) going to exhibitions or museums, 12) meeting friends, 13) walking, 14) listening to the radio, 15) travelling, 16) gardening, 17) painting, drawing or taking photos, 18) participating in family or charity activities, 19) outdoor activities, 20) collecting stamps or other items, 21) cooking, 22) writing, 23) doing housework, 24) attending religious activities, 25) playing musical instruments, 26) playing solitaire, 27) following the stock market or investing, 28) playing bingo, 29) singing\].
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.
The control group (CG) will not receive any intervention during the study period. At the end of the study, the control group will be offered to participate in either of the following two interventions.
There will be a pre-intervention, post-intervention assessment and two follow-ups at 6 and 12 months. Firstly, an assessment protocol will be used with ad hoc socio-demographic variables, referring to clinical characteristics and in relation to lifestyle. These variables will be collected in a socio-health record. In addition, if participants do not have a diagnosis of MCI, the MEC-35 will be used to apply the inclusion and exclusion criteria.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention group 1 (GI1)
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.
Cognitive stimulation
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 2 (GI2)
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.
Stimulating leisure activities
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.
Control Group (CG)
The control group (CG) will not receive any intervention during the study period.
No interventions assigned to this group
Interventions
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Cognitive stimulation
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.
Stimulating leisure activities
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.
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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.
50 Years
ALL
Yes
Sponsors
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Universidad de Zaragoza
OTHER
Responsible Party
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Isabel Gómez-Soria
Assistant professor doctor
Locations
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Centro de Salud Arrabal
Zaragoza, Zaragoza, Spain
Countries
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Facility Contacts
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Grupo Aragonés de Investigación en Atención Primaria
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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U
Identifier Type: -
Identifier Source: org_study_id