Clinical trial NCT05468424: Effect of Tablet-Based Games on Executive Functions in Older Adults With Mild Cognitive Impairment
Official title: Effect of Tablet-Based Games on Executive Functions in Older Adults With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: video games, tablet
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 42
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to investigate whether a tablet-based role-playing game is more effective than tablet-based word or image puzzles at improving executive functions in older adults with mild cognitive impairment. The secondary objective of this study is to investigate whether a tablet-based role-playing game will show higher levels of engagement (measured by time played) in older adults with mild cognitive impairment than tablet-based word or image puzzles.

Detailed description: The purpose of this study is to examine the use of tablet-based (iPad or android) video games as a means of improving executive functions in older adults with mild cognitive impairment (Petersen, Smith, Waring, et al., 1999). The worldwide rising average age of the population and increasing incidence of dementia has created an urgent need for the development of effective and engaging therapies to mitigate age- and dementia-related cognitive decline. Much evidence supports the use of cognitive therapies as a means of improving general cognition in older adults. Video games may offer benefits over traditional cognitive therapies as they are challenging and fun, provide frequent feedback which motivates and encourages user engagement, and are widely available at low cost on tablet devices. This study will be implemented as a single blinded randomized control trial structured as a 2 x 2 mixed design with one repeated factor (time: pre-training, post-training) and one between-subject factor (group: treatment, active control). Forty-two older adults with mild cognitive impairment will be randomly assigned to play either a role-playing game, or a selection of word or image puzzles, for 5 or more hours a week for a period of 8 weeks. Participants can have a study partner assist them in the study. A study partner can help the participant with using the tablet and navigating menu in the game, but cannot play the game along with the participant. Participants will be assessed pre and post training with the Cambridge Brain Sciences (www.cambridgebrainsciences.com) online battery of 12 cognitive tasks. These tasks are "based on well-established paradigms from the cognitive neuroscience literature, to measure planning, reasoning, attention, and working memory abilities" (Hampshire, Highfield, Parkin, et al., 2012, p. 1236).

Eligibility criteria: Inclusion Criteria:

* 60 years of age or older
* fluent in English
* diagnosis of mild cognitive impairment
* normal or corrected hearing and vision
* can operate the touch screen on an iPad
* access to a tablet (iPad or android) for 8 weeks of the study

Exclusion Criteria:

* have started taking memory medication in the last 3 months
* have experience in any of the tablet-based games included in the study

Primary outcomes:
measure: response inhibition
timeFrame: 8 weeks
measure: attention
timeFrame: 8 weeks
measure: verbal short-term memory
timeFrame: 8 weeks
measure: spatial short-term memory
timeFrame: 8 weeks
measure: working memory
timeFrame: 8 weeks
measure: visuospatial working memory
timeFrame: 8 weeks
measure: visuospatial rotations
timeFrame: 8 weeks
measure: visuospatial processing
timeFrame: 8 weeks
measure: deductive reasoning
timeFrame: 8 weeks
measure: verbal reasoning
timeFrame: 8 weeks
measure: planning
timeFrame: 8 weeks
Secondary outcomes:
measure: engagement
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Providence Care Hospital
state: Ontario
city: Toronto
country: Canada
facility: Baycrest Academy
state: Ontario
Study officials:
affiliation: Providence Care Hospital
name: John Puxty, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baycrest Academy
name: Nicole Anderson, PhD
role: PRINCIPAL_INVESTIGATOR
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