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Effect of Digital Cognitive Training on the Functionality of Older Adults With Mild Cognitive Impairment (MCI)

U

Universidade Federal do Rio de Janeiro

Status and phase

Unknown
Phase 1

Conditions

Aging
Mild Cognitive Impairment

Treatments

Behavioral: digital cognitive training

Study type

Interventional

Funder types

Other

Identifiers

NCT03911765
17976113.1.0000.5257

Details and patient eligibility

About

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

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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;

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

40 participants in 2 patient groups

Executive Function cognitive training
Experimental group
Description:
20 hours of digital cognitive training targeting executive function.
Treatment:
Behavioral: digital cognitive training
Games
Active Comparator group
Description:
10 hours of computer games c available online which do not involve a high demand in cognitive functions (e.g. fishing game, pinball game, tetris, etc), followed by 10 hours of of digital cognitive training targeting executive function.
Treatment:
Behavioral: digital cognitive training

Trial contacts and locations

1

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Central trial contact

Rogério Panizzutti

Data sourced from clinicaltrials.gov

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