Clinical trial NCT06579378: Feasibility Study of Virtual Sail 3D in Cognitive Functions
Official title: Virtual Sail 3D - A Feasibility Study for Enhancing Cognitive Functions in Elderly People
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Virtual reality
Feasibility
Cognitive functions
Sail
Advances Technologies Laboratory
Lead sponsor: University of Cagliari
Sponsor class: OTHER
Collaborators: name: Fondazione di Sardegna
First posted: 2024-08-30
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: PREVENTION

Brief summary: This research project will assess the feasibility and preliminary effectiveness of a 6-week intervention to improve cognitive functions using the 3D immersive virtual reality software "CEREBRUM" with virtual sailing scenarios among elderly with mild cognitive impairment. CEREBRUM, developed by PRoMIND in association with IDEGO, is the first European tool for enhancing cognitive functions via 3D immersive virtual reality in psychosocial disabilities. Previous studies have shown its effectiveness in improving cognitive functions and well-being in people with bipolar disorders. The software includes modules for memory, learning, cognitive estimations, attention, working memory, and executive functions. For this study, the software was developed with sailing virtual scenarios to make it more enjoyable and engaging, as well as to train other cognitive functions such as motor skills and language abilities among people with disabilities.

Detailed description: Research on active aging has been identified as a priority, particularly concerning the feasibility and effectiveness of non-pharmacological interventions aimed at preventing and/or delaying cognitive decline. Risk factors such as physical, cognitive, and social inactivity are estimated to account for about 40% of the risk of developing dementia in the lifetime. Recent reviews have shown that cognitive remediation interventions are effective in improving cognitive performance in older adults with and without cognitive decline.

Cognitive remediation is a behavior-based training intervention aimed at improving cognitive functions (memory, attention, executive functions, social cognition, and metacognition) to achieve lasting results and their generalization. There is substantial evidence supporting the effectiveness of such interventions in neuropsychological disorders such as dementia, mild cognitive impairment, and behavioral disorders.

In recent years, there has been an increase in the use of immersive 3D virtual reality software in clinical and rehabilitative settings as tools for rehabilitation and the improvement of various skills. To date, there are few studies where immersive 3D virtual reality is used to enhance cognitive functions related to personal and social functioning, especially to prevent cognitive decline in older adults (aged 65 and over).

This research project will assess the feasibility and preliminary effectiveness of a 6-week intervention to improve cognitive functions using the 3D immersive virtual reality software "CEREBRUM" with sailing scenarious among elderly with mild cognitive impairment.

Eligibility criteria: Inclusion Criteria:

* Age: 65 years or older
* Sex: all
* Living independently,
* Without conditions that would prevent them from participating in the activities of the experimental intervention "VSail 3D,"
* Without severe issues with autonomous mobility
* With Mild Cognitive Impairment (MCI) according to Addenbrooke's Cognitive Examination for cognitive functions (ACE-R), which also includes the Mini-Mental State Examination (MMSE), with the following ranges: ACE = 66.93-79.86 and/or MMSE = 21-25.
* Signing the informed consent

Exclusion Criteria:

* severe cardiovascular conditions
* severe issues with autonomous mobility
* severe metabolic disorders not pharmacologically compensated
* severe neurological conditions that prevent from participating in the experimental protocol, such as a stroke within the past 2 years, Parkinson's disease, epilepsy, or dementia (Alzheimer's, vascular, etc.)
* severe ongoing bronchopulmonary disorders
* severe ongoing renal disorders
* glaucoma, retinal detachment, or other serious vision conditions that do not allow the safe use of 3D virtual reality technology
* active malignant neoplasm that do not allow the hinders participation in the intervention.

Primary outcomes:
measure: Dropout rates; Proportion of recruited participants among those considered eligible;
timeFrame: T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)
measure: Simulator Sickness Questionnaire (SSQ)
timeFrame: T0 (0 weeks) - T1 (6 weeks)
measure: Self-report satisfaction questionnaire
timeFrame: T1 (6 weeks)
Secondary outcomes:
measure: Trail Making Test
timeFrame: T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)
measure: Digit Span
timeFrame: T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)
measure: Stroop Test
timeFrame: T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)
measure: Rey Figure Test
timeFrame: T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)
measure: Frontal Assessment Battery (FAB)
timeFrame: T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)
measure: Matrix test
timeFrame: T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)
measure: Rey's Word Test
timeFrame: T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)
measure: Addenbrooke's Cognitive Examination (ACE-R)
timeFrame: T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)
Other outcomes:
measure: Short Form Health Survey, 12 items (SF-12)
timeFrame: T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)
measure: Generalized Anxiety Disorder-7 item (GAD-7)
timeFrame: T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)
measure: Brief Social Rhythms Scale (BSRS)
timeFrame: T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)
measure: Physical Body Experiences Questionnaire Simplified for Active Aging (PBE-QAG)
timeFrame: T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)
measure: Sway area in the presence and absence of visual input
timeFrame: T0 (0 weeks); T1 (6 weeks)
measure: Gait speed
timeFrame: T0 (0 weeks); T1 (6 weeks)
measure: Timed up and go time
timeFrame: T0 (0 weeks); T1 (6 weeks)
Locations:
city: Cagliari
country: Italy
facility: University Hospital of Cagliari
state: CA
Study officials:
References: