Clinical trial NCT04835909: Board Games Among Mild Cognitive Impairment Patients Experience (GAME Project)
Official title: Effectiveness on Cognition of a Cognitive Training Intervention Based on Modern Board and Card Games in Mild Cognitive Impairment Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Impairment, Mild
Keywords: Memory
Executive Functions
Cognitive training
Cognitive enrichment
Modern board and card games
Lead sponsor: Brain In Game scientific-technical service
Sponsor class: OTHER
Collaborators: name: University Hospital of Santa Maria, Lleida
First posted: 2021-04-08
Enrollment: 112
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Nowadays, on geriatric centres, cognitive decline used to be prevented by pen and paper exercises (Calero García \& Navarro Gonzalez, 2006). However, as Lampit et al. (2014) suggest, studies based on the efficacy and effectiveness of new cognitive-based interventions in order to improve these cognitive processes are fundamental (Lampit et al., 2014). Cognitive-based interventions are interventions that directly or indirectly try to improve cognitive processes (Chiu et al., 2017). Between the different kinds of cognitive-based interventions, cognitive training permits stablish randomized controlled trials. Cognitive training consists of repeating during a concrete time a standardized set of tasks in order to maintain or improve one or some cognitive processes. Meta-analysis studies have shown that computerized cognitive training can improve in a moderate size some cognitive processes in elderly people with mild cognitive impairment or dementia (Hill et al., 2017) and without those diagnoses (Lampit, Hallock, \& Valenzuela, 2014; Chiu et al., 2017). Although it seems that computerized training is effective, safe and secure, it is important to note the social component of the definition of health (OMS, 1948). Chang, Wray \& Lin (2014) found that social relationships predict the use of leisure activities and this predict a better physical health and wellbeing psychological. In fact, a comparative study found that those elderly people that have played board games have a 15% lower risk of having dementia diagnose and problems related with memory (Dartigues et al., 2013). To sum up, the aim of this research project is to test the effectiveness of a cognitive training based on modern board and card games in elderly people with a diagnose of mild-cognitive impairment in comparison to do cognitive paper and pencil tasks or in a wait-list comparison group.


Eligibility criteria: Inclusion Criteria:

* Participation in cognitive disease center
* Amnestic MCI diagnoses (clinical diagnoses following the guidelines of Petersen et al. 2011)
* Global deterioration scale (GDS) 2-3 values
* Participation assessing outcomes of the caregivers in the study

Exclusion Criteria:

* Participation in another cognitive training program
* Dementia, neurologic or other disease non-neurodegenerative, which could affect cognitive change over time (medical-reported)
* Severe visual impairment, language impairment or motoric impairment of the upper extremity which significantly affects ability to solve jigsaw puzzles (medical-reported)

Primary outcomes:
measure: Change in cognitive impairment from baseline to post intervention
timeFrame: Baseline and post intervention (after 16 weeks)
measure: Change in visuoconstruction, immediate memory and long-term memory from baseline to post intervention
timeFrame: Baseline and post intervention (after 16 weeks)
measure: Change in verbal long-term memory from baseline to post intervention
timeFrame: Baseline and post intervention (after 16 weeks)
measure: Change in verbal short-term memory from baseline to post intervention
timeFrame: Baseline and post intervention (after 16 weeks)
measure: Change in verbal working memory from baseline to post intervention
timeFrame: Baseline and post intervention (after 16 weeks)
measure: Change in visuospatial short-term memory from baseline to post intervention
timeFrame: Baseline and post intervention (after 16 weeks)
measure: Change in visuospatial working memory from baseline to post intervention
timeFrame: Baseline and post intervention (after 16 weeks)
measure: Change in visuospatial processing from baseline to post intervention
timeFrame: Baseline and post intervention (after 16 weeks)
measure: Change in flexibility from baseline to post intervention
timeFrame: Baseline and post intervention (after 16 weeks)
measure: Change in inhibition from baseline to post intervention
timeFrame: Baseline and post intervention (after 16 weeks)
measure: Change in phonemic and semantic fluency from baseline to post intervention
timeFrame: Baseline and post intervention (after 16 weeks)
Secondary outcomes:
measure: Change in neuropsychiatric symptoms from baseline to post intervention
timeFrame: Baseline and post intervention (after 16 weeks)
measure: Change in psychological well-being from baseline to post intervention
timeFrame: Baseline and post intervention (after 16 weeks)
measure: Change in depressive symptoms from baseline to post intervention
timeFrame: Baseline and post intervention (after 16 weeks)
Other outcomes:
measure: Social Status Index and sociodemographical information
timeFrame: Baseline
measure: Cognitive reserve questionnaire
timeFrame: Baseline
measure: Premorbid cognitive function
timeFrame: Baseline
Locations:
city: Lleida
country: Spain
facility: Faculty of Education, Psychology and Social Work; University of Lleida
city: Lleida
country: Spain
facility: Cognitive disorders unity, Santa Maria's University Hospital, GSS
Study officials:
References:
citation: Calero García, M. D., & Navarro Gonzalez, E. (2006). Eficacia de un programa de entrenamiento en memoria en el mantenimiento de ancianos con y sin deterioro cognitivo. Clínica y Salud, 17(2), 187-202.
citation: Chang PJ, Wray L, Lin Y. Social relationships, leisure activity, and health in older adults. Health Psychol. 2014 Jun;33(6):516-23. doi: 10.1037/hea0000051.
citation: Chiu HL, Chu H, Tsai JC, Liu D, Chen YR, Yang HL, Chou KR. The effect of cognitive-based training for the healthy older people: A meta-analysis of randomized controlled trials. PLoS One. 2017 May 1;12(5):e0176742. doi: 10.1371/journal.pone.0176742. eCollection 2017.
citation: Dartigues JF, Foubert-Samier A, Le Goff M, Viltard M, Amieva H, Orgogozo JM, Barberger-Gateau P, Helmer C. Playing board games, cognitive decline and dementia: a French population-based cohort study. BMJ Open. 2013 Aug 29;3(8):e002998. doi: 10.1136/bmjopen-2013-002998.
citation: Hill NT, Mowszowski L, Naismith SL, Chadwick VL, Valenzuela M, Lampit A. Computerized Cognitive Training in Older Adults With Mild Cognitive Impairment or Dementia: A Systematic Review and Meta-Analysis. Am J Psychiatry. 2017 Apr 1;174(4):329-340. doi: 10.1176/appi.ajp.2016.16030360. Epub 2016 Nov 14.
citation: Lampit A, Hallock H, Valenzuela M. Computerized cognitive training in cognitively healthy older adults: a systematic review and meta-analysis of effect modifiers. PLoS Med. 2014 Nov 18;11(11):e1001756. doi: 10.1371/journal.pmed.1001756. eCollection 2014 Nov.