Clinical trial NCT03911765: Effect of Digital Cognitive Training on the Functionality of Older Adults With Mild Cognitive Impairment (MCI)
Official title: Effect of Digital Cognitive Training on the Functionality of Older Adults With Mild Cognitive Impairment (MCI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Mild Cognitive Impairment
Aging
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped wedge
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to investigate the effect of digital cognitive training in the functionality of older adults with Mild Cognitive Impairment.

Detailed description: Mild Cognitive Impairment (MCI) is characterized by decline in one or more cognitive domains, including memory, attention, executive functions, language and visuospatial abilities, and in a significant portion of cases may evolve to Alzheimer's Disease. According to established diagnostic criteria, independence for daily life activities is preserved, but activities are carried out less effectiveness and efficiency, affected subjects usually take more time and make more mistakes, when compared to their pre-morbid performance. Different studies have observed that impairments in functional performance in older adults with MCI are associated with impairments in executive function. This study intends to verify the impact of the use of digital cognitive training for executive function on the functionality of older adults with MCI. Digital cognitive exercises, used in the intervention group, have the primary objective of stimulating executive functions, and will be made available through the Internet using the BrainHQ platform. The active control group will play computer games available online. Both groups will play for 1 hour at least 2 times per week.

After baseline assessments, older adults with MCI will be stratified by age, education, gender, functional measurement and cognitive assessment, and randomly assigned to the intervention group with digital cognitive exercises or to the control group with computer games, in a stepped wedge design. Subjects will be evaluated at baseline and after completing 10 and 20 hours of intervention. After the first 10 hours of intervention both groups will be assigned to the intervention with digital cognitive exercises for additional 10 hours. Both groups will be comparable in terms of personal contact with staff and computer time. Our hypothesis is that the training using digital cognitive exercises will improve the executive function and that this gain has a positive impact on the functionality and accomplishment of the daily life activities of older adults with MCI.

Eligibility criteria: Inclusion Criteria:

* Age above 65 years old;
* Elderly enrolled in home for aged in wich the research is taking place;
* Montreal Cognitive Assessment above 21 points;

Exclusion Criteria:

* Clinical diagnosis of Alzheimer's Disease;
* Serious medical or neurological condition preventing from participation in the study;

Primary outcomes:
measure: Performance in everyday living score change
timeFrame: 3 months
Secondary outcomes:
measure: Functional status score change
timeFrame: 3 months
Other outcomes:
measure: Global cognitive function score change
timeFrame: 3 months
measure: Semantic memory score change
timeFrame: 3 months
measure: Selective attention and cognitive flexibility
timeFrame: 3 months
measure: Sustained attention and set-shifting
timeFrame: 3 months
measure: Depression score change
timeFrame: 3 months
measure: Qualitative motivation with the computerized training exercise
timeFrame: 3 months
Locations:
city: Rio de Janeiro
country: Brazil
facility: Universidade Federal do Rio de Janeiro
state: RJ
Study officials:
References: