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Status unknownNCT04835909GAME-ProjectUpdated Apr 8, 2021

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

An interventional study of Modern board and card games group and Paper and pencil tasks group in Cognitive Impairment, Mild, sponsored by Brain In Game scientific-technical service. Status unknown at 2 sites in Spain. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2021-04-08.

Sponsored by Brain In Game scientific-technical service · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
60 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Cognitive Impairment, Mild

Keywords

  • Memory
  • Executive Functions
  • Cognitive training
  • Cognitive enrichment
  • Modern board and card games
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In context

Cognitive Dysfunction

3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.

This study's planned enrollment of 112 is above the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Brain In Game scientific-technical service is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
112 participants (estimated)

Study arms

  • Experimental
    Behavioral: modern board and card games

    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

  • Active comparator
    Behavioral: paper and pencil tasks

    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

  • No intervention
    Wait-list

    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

  • BehavioralModern board and card games group

    Modern board and card games group

  • BehavioralPaper and pencil tasks group

    Paper and pencil tasks group

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What researchers measure

Primary outcomes

  1. Change in cognitive impairment from baseline to post intervention

    Addenbrooke's Cognitive Examination

    Time frame: Baseline and post intervention (after 16 weeks)

  2. 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

    Time frame: Baseline and post intervention (after 16 weeks)

  3. Change in verbal long-term memory from baseline to post intervention

    Rey Auditory Verbal Learning Test (RAVLT)

    Time frame: Baseline and post intervention (after 16 weeks)

  4. Change in verbal short-term memory from baseline to post intervention

    Digit Memory Test Forward

    Time frame: Baseline and post intervention (after 16 weeks)

  5. Change in verbal working memory from baseline to post intervention

    Digit Memory Test Backward

    Time frame: Baseline and post intervention (after 16 weeks)

  6. Change in visuospatial short-term memory from baseline to post intervention

    Visual Memory Test Forward

    Time frame: Baseline and post intervention (after 16 weeks)

  7. Change in visuospatial working memory from baseline to post intervention

    Visual Memory Test Backward

    Time frame: Baseline and post intervention (after 16 weeks)

  8. Change in visuospatial processing from baseline to post intervention

    Trail Making Test A and Symbol Digit Modalities Test (SDMT)

    Time frame: Baseline and post intervention (after 16 weeks)

  9. Change in flexibility from baseline to post intervention

    Trail Making Test B and 5 digits test

    Time frame: Baseline and post intervention (after 16 weeks)

  10. Change in inhibition from baseline to post intervention

    5 digits test

    Time frame: Baseline and post intervention (after 16 weeks)

  11. Change in phonemic and semantic fluency from baseline to post intervention

    Animals category and P, M, R letters, Spanish version

    Time frame: Baseline and post intervention (after 16 weeks)

Secondary outcomes

  1. Change in neuropsychiatric symptoms from baseline to post intervention

    Neuropsychiatric Inventory (NPI), Self-reported and caregivers spanish versions. Higher scores mean higher neuropsychiatric symptomatology.

    Time frame: Baseline and post intervention (after 16 weeks)

  2. 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.

    Time frame: Baseline and post intervention (after 16 weeks)

  3. 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.

    Time frame: Baseline and post intervention (after 16 weeks)

Other outcomes

  1. Social Status Index and sociodemographical information

    Hollingshead Index, age, sex, birth location

    Time frame: Baseline

  2. Cognitive reserve questionnaire

    Cognitive reserve questionnaire (CRC), spanish version

    Time frame: Baseline

  3. Premorbid cognitive function

    The Word Accentuation Test (TAP), spanish version

    Time frame: Baseline

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Study locations

2 of 2 sites recruiting
  • Faculty of Education, Psychology and Social Work; University of Lleida
    Lleida, 25001, Spain
    • Jorge Moya-Higueras, PhD · Contact · jorge.moya@udl.cat · 973706509
    • Jaume March-Llanes, PhD · Principal investigator
    • Verónica Estrada-Plana, MsC · Sub investigator
    Recruiting
  • Cognitive disorders unity, Santa Maria's University Hospital, GSS
    Lleida, 25198, Spain
    • Beatriu Lara Consuegra, MsC · Contact · blara@gss.cat · +34 972727222
    Recruiting
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References and documents

Publications

  • 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. PubMed 24884905 ↗
  • 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. PubMed 28459873 ↗
  • 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. PubMed 23988362 ↗
  • 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. PubMed 27838936 ↗
  • 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. PubMed 25405755 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04835909
Lead sponsor
Brain In Game scientific-technical service
Collaborators
University Hospital of Santa Maria, Lleida
Responsible party
jaume march llanes (Effectiveness on Cognition of a Cognitive Training Intervention Based on Modern Board and Card Games in Mild Cognitive Impairment Patients: a Randomized Controlled Trial, Brain In Game scientific-technical service) — Principal investigator
First posted
Apr 8, 2021
Start date
Feb 16, 2021
Primary completion
Mar 2024 (estimated)
Completion
Mar 2024 (estimated)
Last update
Apr 8, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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