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

NCT04835909 | Unknown DMC

• 1 other identifier: NCT2021UTC
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 2

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.

Conditions

Cognitive Impairment, Mild

Keywords

Memory; Executive Functions; Cognitive training; Cognitive enrichment; Modern board and card games

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (3)

• Change in neuropsychiatric symptoms from baseline to post intervention

  Baseline and post intervention (after 16 weeks)

• Change in psychological well-being from baseline to post intervention

  Baseline and post intervention (after 16 weeks)

• Change in depressive symptoms from baseline to post intervention

  Baseline and post intervention (after 16 weeks)

Other Outcomes (3)

• Social Status Index and sociodemographical information

  Baseline

• Cognitive reserve questionnaire

  Baseline

• Premorbid cognitive function

  Baseline

Study Arms (3)

Behavioral: modern board and card games

EXPERIMENTAL

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

Behavioral: paper and pencil tasks

ACTIVE COMPARATOR

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

Wait-list

NO INTERVENTION

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.

Interventions

Modern board and card games group BEHAVIORAL

Modern board and card games group

Behavioral: modern board and card games

Paper and pencil tasks group BEHAVIORAL

Paper and pencil tasks group

Behavioral: paper and pencil tasks

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brain In Game scientific-technical service: lead
• University Hospital of Santa Maria, Lleida: collaborator

Study Sites (2)

Faculty of Education, Psychology and Social Work; University of Lleida

Lleida, 25001, Spain

RECRUITING

Cognitive disorders unity, Santa Maria's University Hospital, GSS

Lleida, 25198, Spain

RECRUITING

Related 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.

  BACKGROUND

• 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.

  PMID: 24884905 BACKGROUND

• 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.

  PMID: 28459873 BACKGROUND

• 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.

  PMID: 23988362 BACKGROUND

• 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.

  PMID: 27838936 BACKGROUND

• 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.

  PMID: 25405755 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Paper

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI 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 Record Dates

• First Submitted: March 22, 2021
• First Posted: April 8, 2021
• Study Start: February 16, 2021
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

ES (2)