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

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness on Cognition of a Cognitive Training Intervention Based on Modern Board and Card Games in Mild Cognitive Impairment Patients: a Randomized Controlled Trial

Conditions
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Cognitive Impairment, Mild

Intervention / Treatment
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* Behavioral: Modern board and card games group
* Behavioral: Paper and pencil tasks group


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral: modern board and card games<br>Participants will play modern board and card games in groups at medical center 2 times per week for at least 1 hour over a period of 16 weeks. | Behavioral: Modern board and card games group<br>* Modern board and card games group<br>|
| Active Comparator: Behavioral: paper and pencil tasks<br>Participants will do cognitive paper and pencil tasks in groups at medical center 2 times per week for at least 1 hour over a period of 16 weeks. | Behavioral: Paper and pencil tasks group<br>* Paper and pencil tasks group<br>|
| No Intervention: Wait-list<br>Participants will be in a wait-list over a period of 16 weeks. Then, they received the board and card games' or paper and pencil tasks' intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cognitive impairment from baseline to post intervention | Addenbrooke's Cognitive Examination | Baseline and post intervention (after 16 weeks) | 
| 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) | 
| Change in verbal long-term memory from baseline to post intervention | Rey Auditory Verbal Learning Test (RAVLT) | Baseline and post intervention (after 16 weeks) | 
| Change in verbal short-term memory from baseline to post intervention | Digit Memory Test Forward | Baseline and post intervention (after 16 weeks) | 
| Change in verbal working memory from baseline to post intervention | Digit Memory Test Backward | Baseline and post intervention (after 16 weeks) | 
| Change in visuospatial short-term memory from baseline to post intervention | Visual Memory Test Forward | Baseline and post intervention (after 16 weeks) | 
| Change in visuospatial working memory from baseline to post intervention | Visual Memory Test Backward | Baseline and post intervention (after 16 weeks) | 
| 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) | 
| Change in flexibility from baseline to post intervention | Trail Making Test B and 5 digits test | Baseline and post intervention (after 16 weeks) | 
| Change in inhibition from baseline to post intervention | 5 digits test | Baseline and post intervention (after 16 weeks) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Memory, Executive Functions, Cognitive training, Cognitive enrichment, Modern board and card games