Neurocognitive Disorders
Conditions
Interventions
L01.224.160.875
This is a double-blind randomized clinical trial, which will be carried out at the geriatrics outpatient clinic of the Central Institute of the Clinical Hospital of the Faculty of Medicine of the Univ
Sponsors
Faculdade de Medicina da Universidade de São Paulo
Faculdade de Medicina da Universidade de São Paulo
Eligibility
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: Will be included (1) elderly patients (>60 years old); (2) of both genders; (3) with adequate command of the Portuguese language; that are classified into one of the following two categories: (3) Mild Neurocognitive Disorder – at least one domain with composite score less than or equal to – 1, but without criteria for dementia; (4) Mild Major Neurocognitive Disorder with CDR less than 2 and (5) accepting to participate in the study by signing the Informed Consent Form.
Exclusion criteria
Exclusion criteria: Individuals with (1) previous diagnosis of major neurocognitive disorder with CDR greater than or equal to 2 will be excluded; (2) presence of delirium, psychotic mental disorders, or substance-related mental disorders according to DSM-5 criteria; (3) severe retinal problems or severe visual impairment using corrective lenses; (4) severe uncorrected hearing deficit; (5) have decompensated cardiovascular diseases, such as angina, heart failure; (6) epilepsy; (7) motion sickness; (8) experiencing cybersickness during the familiarization game (9) health problem that makes it impossible to use immersive Virtual Reality; (10) serious clinical conditions with uncontrolled symptoms or instability and (11) missing the first 2 consecutive sessions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find an improvement in patients' cognitive performance through an increase in the SGHC-FMUSP Neurocognitive Battery score and the Word Stress Test – Brazilian version (TAP-Br) with 40 items. Data distribution will be analyzed using the Kilmogorov Smirnov test. The Z score will be used to normalize non-parametric distribution data. Continuous data will be compared using the General Linear Model (GLM) test for repeated measures and univariate GLM (for group comparison). The significance level to be considered will be a 5% variation in pre- and post-intervention measurements. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to find an improvement in patients' motor performance through increased scores in physical assessments that include the Mini-BESTest, the Gait Deviation Index (GDI), the 1-minute sit test, Box and Blocks and the Palmar Grip Test. . Data distribution will be analyzed using the Kilmogorov Smirnov test. The Z score will be used to normalize non-parametric distribution data. Continuous data will be compared using the General Linear Model (GLM) test for repeated measures and univariate GLM (for group comparison). The significance level to be considered will be a 5% variation in pre- and post-intervention measurements.;It is expected to find an improvement in patients' functionality with a decrease in scores on the Functional Activities Questionnaire – FAQ. Data distribution will be analyzed using the Kilmogorov Smirnov test. The Z score will be used to normalize non-parametric distribution data. Continuous data will be compared using the General Linear Model (GLM) test for repeated measures and univariate GLM (for group comparison). The significance level to be considered will be a 5% variation in pre- and post-intervention measurements.;It is expected to find an improvement in patients' mood through improved scores on the Patient Health Questionnaire (PHQ-9) and General Anxiety Disorder Scale (GAD-7). Data distribution will be analyzed using the Kilmogorov Smirnov test. The Z score will be used to normalize non-parametric distribution data. Continuous data will be compared using the General Linear Model (GLM) test for repeated measures and univariate GLM (for group comparison). The significance level to be considered will be a 5% variation in pre- and post-intervention measurements.;Verify the acceptability and satisfaction of an immersive Virtual Reality protocol with commercial games through a questionnaire to assess possible discomforts in relation to immersive Virtual Reality, the "Simulator sickness questionnaire", in its Brazilian version, and a sat | — |
Countries
Brazil
Contacts
Public ContactMaristela Tikhomiroff
Faculdade de Medicina da Universidade de São Paulo
Outcome results
None listed