Board Games Among Mild Cognitive Impairment Patients Experience (GAME Project)

Cognitive Impairment, Mild Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04835909
• Other study ID #: NCT2021UTC
• Status: Recruiting
• Phase: N/A
• Start date: February 16, 2021
• Est. completion date: March 2024

Study information

• Verified date: April 2021
• Source: Brain In Game scientific-technical service
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment, Mild

Intervention

Behavioral:
• Modern board and card games group
Modern board and card games group
• Paper and pencil tasks group
Paper and pencil tasks group

Locations

Country	Name	City	State
Spain	Cognitive disorders unity, Santa Maria's University Hospital, GSS	Lleida
Spain	Faculty of Education, Psychology and Social Work; University of Lleida	Lleida

Sponsors (2)

Lead Sponsor	Collaborator
Brain In Game scientific-technical service	University Hospital of Santa Maria, Lleida

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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.

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. — View 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. — View 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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Social Status Index and sociodemographical information	Hollingshead Index, age, sex, birth location	Baseline
Other	Cognitive reserve questionnaire	Cognitive reserve questionnaire (CRC), spanish version	Baseline
Other	Premorbid cognitive function	The Word Accentuation Test (TAP), spanish version	Baseline
Primary	Change in cognitive impairment from baseline to post intervention	Addenbrooke's Cognitive Examination	Baseline and post intervention (after 16 weeks)
Primary	Change in visuoconstruction, immediate memory and long-term memory from baseline to post intervention	Copy, draw after 3 and after 25 minuts of Rey-Osterrieth Complex Figure Test	Baseline and post intervention (after 16 weeks)
Primary	Change in verbal long-term memory from baseline to post intervention	Rey Auditory Verbal Learning Test (RAVLT)	Baseline and post intervention (after 16 weeks)
Primary	Change in verbal short-term memory from baseline to post intervention	Digit Memory Test Forward	Baseline and post intervention (after 16 weeks)
Primary	Change in verbal working memory from baseline to post intervention	Digit Memory Test Backward	Baseline and post intervention (after 16 weeks)
Primary	Change in visuospatial short-term memory from baseline to post intervention	Visual Memory Test Forward	Baseline and post intervention (after 16 weeks)
Primary	Change in visuospatial working memory from baseline to post intervention	Visual Memory Test Backward	Baseline and post intervention (after 16 weeks)
Primary	Change in visuospatial processing from baseline to post intervention	Trail Making Test A and Symbol Digit Modalities Test (SDMT)	Baseline and post intervention (after 16 weeks)
Primary	Change in flexibility from baseline to post intervention	Trail Making Test B and 5 digits test	Baseline and post intervention (after 16 weeks)
Primary	Change in inhibition from baseline to post intervention	5 digits test	Baseline and post intervention (after 16 weeks)
Primary	Change in phonemic and semantic fluency from baseline to post intervention	Animals category and P, M, R letters, Spanish version	Baseline and post intervention (after 16 weeks)
Secondary	Change in neuropsychiatric symptoms from baseline to post intervention	Neuropsychiatric Inventory (NPI), Self-reported and caregivers spanish versions. Higher scores mean higher neuropsychiatric symptomatology.	Baseline and post intervention (after 16 weeks)
Secondary	Change in psychological well-being from baseline to post intervention	Euro Quality of Life Scale (EQ-5D), Self-reported and caregivers spanish versions. Higher scores mean higher quality of life. Visual analogue scale: minimum value=0, maximum value=100.	Baseline and post intervention (after 16 weeks)
Secondary	Change in depressive symptoms from baseline to post intervention	Geriatric Depression Scale (GDS), Spanish version. Higher scores mean higher depressive symptomatology. Minimum value = 0, maximum value = 15.	Baseline and post intervention (after 16 weeks)