Multimodal Immersive Virtual Reality Training for Improving Cognition in Adults With Metabolic Syndrome: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Differences between groups in scores of global cognition
研究概览
简要总结
This study aims to evaluate the effectiveness of a multimodal intervention using immersive virtual reality (Virtual-METS) to improve cognitive function in middle-aged adults with metabolic syndrome and subjective cognitive complaints. The intervention combines cognitive training and physical exercise in group sessions over 12 weeks.
详细描述
Metabolic syndrome (MetS) has been associated with an increased risk of cognitive decline and potentially Alzheimer's disease. Given the high prevalence of MetS in older adult populations, there is an urgent need for alternative, non-pharmacological solutions to improve cognitive impairment associated with MetS. Immersive Virtual Reality (IVR) technology offers a unique opportunity to improve traditional interventions and accessibility for populations with physical, cognitive, or emotional constraints. The Virtual-METS project aims to evaluate the effects of a multimodal IVR intervention that combines cognitive training and physical exercise on eighty- four adults with MetS, aged between 45 and 70 years, and with subjective cognitive complaints. Participants will be randomly assigned to either the experimental group (Virtual-METS) or the control group (treatment as usual, TAU) in a single-blind, randomized clinical trial. The Virtual-METS intervention will be delivered in a group session with 5 participants, twice per week for 12 weeks (24 sessions). Measures of cognition, assessed by a neuropsychological battery and eye-tracking tasks (primary measures), as well as treatment compliance, functionality, and quality of life (secondary measures), will be assessed at baseline, post-treatment, and after 6 months. In addition, ophthalmologic examinations, carotid Doppler ultrasound, and a panel of blood-based and gut-derived biomarkers will be collected to explore physiological mechanisms underlying cognitive and clinical changes. An economic evaluation of cost-effectiveness, treatment costs, and quality-adjusted life-years, compared to TAU, will also be conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Demonstrated criteria for the MetS: central obesity (waist circumference ≥ 94 cm for men or ≥ 80 cm for women) and at least 2 of the criteria described as follow: Triglycerides ≥ 150 mg/dl or specific treatment of this lipid disorder; HDL-C < 40 mg/dl (men) or < 50 mg/dl (women) or specific treatment of this lipid disorder; Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg or previously diagnosed hypertension treatment; Basal glycemia ≥ 100 mg/dl or type 2 diabetes previously diagnosed).
- •Age: between 45 and 70 years old.
- •Subjective cognitive complaints: Subjective Cognitive Decline Questionnaire (≥ 7).
- •Ability to fully understand and speak Spanish or Catalan.
排除标准
- •Confirmed or suspicion of dementia (MMSE<24).
- •Diagnosis of severe psychiatric, neurological, developmental disorders, systemic pathologies, hematological, hormonal, nutritional pathology, and/or neoplasm that are known to cause cognitive deficits.
- •Other severe comorbidities considered a probable bias for the study: a cardiac history of unstable angina, recent myocardial infarction within the last 3 months, congestive heart failure, significant heart valve dysfunction, or unstable hypertension; taking medications that could negatively affect cognitive function.
- •Physical, motor, or sensory alterations that impede the neuropsychological examination or the rehabilitation program.
研究组 & 干预措施
Experimental: Immersive VR-Based Multimodal Intervention (Virtual-METS)
Participants in this arm will receive a multimodal group-based intervention using immersive virtual reality (IVR) without headsets. The intervention includes mindfulness (10 minutes), cognitive training (30 minutes), and physical exercises (20 minutes) delivered through MK360 immersive technology. Sessions are conducted in groups of 5 participants, twice per week for 12 weeks (24 sessions in total), led by a neuropsychologist.
干预措施: Immersive VR-Based Multimodal Intervention (Virtual-METS) (Behavioral)
No Intervention: Treatment as Usual (Control Group)
Participants in this arm will continue with their usual care, including routine medical visits and remotely administered psychoeducational guidelines to support diet, physical activity, and adherence to pharmacological treatment. They will not receive any specific intervention during the study period.
结局指标
主要结局
Differences between groups in scores of global cognition
时间窗: Baseline, post-intervention (12 weeks), and 6-month follow-up.
Global cognition is assessed with the Montreal Cognitive Assessment (MoCA) a screening tool designed to identify mild cognitive impairment (MCI) and other cognitive deficits. The MoCA takes around 10-15 minutes to complete and consists of 30 items (range=0-30). Higher scores mean a better outcome.
Differences between groups in scores of sustained attention
时间窗: Baseline, post-intervention (12 weeks), and 6-month follow-up.
Sustained attention is measured with the Test of Word Accentuation. Scores range from 0-30, higher scores mean a better performance.
Differences between groups in verbal memory
时间窗: Baseline, post-intervention (12 weeks), and 6-month follow-up.
Verbal memory is measured with the Auditory Verbal Learning Test (AVLT). It is a word-learning test where five presentations of a 15-word list are given, each followed by an attempted recall. This is followed by a second 15-word interference list (list B), followed by recall of list A. Delayed recall and recognition are also tested. For each trial, the score ranges from 0 to 15, with higher scores indicating better memory performance. The total learning score (sum of the five List A trials) ranges from 0 to 75. Delayed recall and recognition scores also range from 0 to 15. Higher scores indicate better verbal memory performance.
Differences between groups in scores of auditory attention
时间窗: Baseline, post-intervention (12 weeks), and 6-month follow-up.
Auditory attention is measured with Digit Span Forward (WAIS-IV). Participants are asked to repeat numbers in the same order as read aloud by the examiner. Scores range from 2 to 8, with higher scores indicating better attention span.
Differences between groups in scores of working memory
时间窗: Baseline, post-intervention (12 weeks), and 6-month follow-up.
Working memory is assessed using Digit Span Backward (WAIS-IV), where participants repeat number sequences in reverse order. Scores range from 2 to 8, with higher scores indicating better working memory.
Differences between groups in scores of processing speed
时间窗: Baseline, post-intervention (12 weeks), and 6-month follow-up.
Processing speed is measured with the Digit Symbol Coding subtest from the WAIS-III. It consists of replacing symbols that lack verbal meaning with numbers based on a key. Scores range from 0 to 133, with higher scores indicating better processing speed.
Differences between groups in scores of sustained attention and impulsivity
时间窗: Baseline, post-intervention (12 weeks), and 6-month follow-up.
Conners Continuous Performance Test - 3rd Edition (CPT-3) is task-oriented computerised assessment of attention-related problems. Participants are presented with a repetitive array of visual stimuli on a computer screen for 14 min. Participants are instructed to press the space bar every time a letter other than "X" appears and to not press the space bar when "X" appears. The rate of stimulus presentation varies according to 1, 2, and 4 s intervals throughout the task. Measures: Correct Detection (Higher rates indicate better outcome), Reaction times (Lower scores indicate better outcome), Omission errors (Lower rates indicate better outcome), and Commission errors (Lower rates indicate better outcome).
Differences between groups in scores of visuospatial memory
时间窗: Baseline, post-intervention (12 weeks), and 6-month follow-up.
Visuospatial memory is assessed with the Brief Visuospatial Memory Test - Revised (BVMT-R). Immediate memory is evaluated through the total score of three learning trials, with scores ranging from 0 to 36. Delayed memory is assessed through free recall (score range: 0 to 12) and recognition (number of correctly identified figures, corrected for false positives). Higher scores indicate better visuospatial memory performance.
Differences between groups in scores of logical memory
时间窗: Baseline, post-intervention (12 weeks), and 6-month follow-up.
Verbal episodic memory is assessed with Logical Memory I and II (WMS-IV), evaluating immediate and delayed recall of short stories. Scores range from 0 to 25 for each story, with a maximum total score of 50 when two stories are administered. In addition, a recognition phase is included, with scores ranging from 0 to 30. Higher scores across all components indicate better verbal episodic memory.
Differences between groups in scores of visual scanning and processing speed
时间窗: Baseline, post-intervention (12 weeks), and 6-month follow-up.
Visual scanning and processing speed are measured with the Trail-Making Test-A version. Participants are asked to connect a series of numbered circles on a page in numerical order. Completion time is recorded in seconds, with lower scores indicating better performance.
Differences between groups in scores of executive function and cognitive flexibility
时间窗: Baseline, post-intervention (12 weeks), and 6-month follow-up.
Executive functioning and cognitive flexibility are measured with the Trail-Making Test-B version. Participants are asked to connect a series of circles that contain both numbers and letters in alternating numerical and alphabetical order. Completion time is recorded in seconds, with lower scores indicating better performance.
Differences between groups in scores of executive functioning
时间窗: Baseline, post-intervention (12 weeks), and 6-month follow-up.
Executive functioning is assessed with the Modified Wisconsin Card Sorting Test (M-WCST), which evaluates abstract reasoning, cognitive flexibility, and the ability to shift problem-solving strategies. Performance is scored based on the number of categories completed, total errors, and perseverative errors. Higher scores in perseverative errors (range: 0 to \>23) and total errors (range: 0 to \>31) indicate worse performance, while more categories completed reflect better executive functioning (range: 0 to 8).
Differences between groups in scores of selective attention, inhibition, and processing speed
时间窗: Baseline, post-intervention (12 weeks), and 6-month follow-up.
Selective attention, inhibition, and processing speed are measured with the Stroop Color and Word Test. Participants are asked to name the color of a series of color patches (Stroop Color Naming), read a series of color words (Stroop Word Reading), and name the color of a series of color words where the word and color do not match (e.g., the word "red" written in blue ink), Stroop Color-Word Interference. Higher scores mean a better outcome.
Differences between groups in scores of phonetic fluency
时间窗: Baseline, post-intervention (12 weeks), and 6-month follow-up.
Phonemic verbal fluency is assessed using the PMR test, in which participants are asked to produce as many words as possible beginning with the letters P, M, and R, one minute per letter. The total score is the sum of all correct, non-repeated words across the three trials. Higher scores indicate better phonemic fluency and executive function.
Differences between groups in scores of semantic verbal fluency
时间窗: Baseline, post-intervention (12 weeks), and 6-month follow-up.
Semantic verbal fluency is assessed with a category fluency task in which participants are asked to name as many words as possible belonging to a specific semantic category (e.g., animals, fruits) within one minute. The total score is the number of correct, non-repeated words produced. Higher scores indicate better semantic fluency and lexical access.
次要结局
- Differences between groups in fasting glucose(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in lipid profile(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in Body Weight(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in waist circumference(Baseline, post-intervention (12 weeks), and 6-month follow-up)
- Differences between groups in blood pressure(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in fasting insulin(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in scores of functionality(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in scores of quality of life(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in cognitive reserve(Baseline only.)
- Differences between groups in gut microbiota and intestinal permeability biomarkers(Baseline and 6-month follow-up.)
- Expectation for treatment at baseline(Baseline only.)
- Differences between groups in subjective cognitive complaints(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in general health status(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in scores of depressive symptoms(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in scores of anxiety symptoms(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in healthy lifestyle habits(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in sedentary behavior(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in scores of Sleep Quality(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in physical performance(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in carotid artery ultrasound measures(Baseline and 6-month follow-up.)
- Differences between groups in scores of eye-tracking data(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in intraocular pressure(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in retinal vascular density (OCTA)(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in Peak systolic velocity of the ophthalmic artery(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in End-diastolic velocity of the ophthalmic artery(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in Resistive index of the ophthalmic artery(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in apolipoproteins and lipoprotein(a)(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in liver function enzymes(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in fasting insulin levels(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in glycated haemoglobin(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in renal function markers(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in glomerular filtration rate (GFR)(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in albuminuria(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in serum electrolytes(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in leptin levels(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in cortisol levels(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in thyroid-stimulating hormone (TSH)(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in creatine phosphokinase (CPK)(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in beta-hydroxybutyrate (BHB)(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in inflammatory cytokines(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
- Differences between groups in brain-derived neurotrophic factor (BDNF)(Baseline, post-intervention (12 weeks), and 6-month follow-up.)
研究者
Maite Garolera
Principal Investigator of the Brain, Cognition, and Behavior Research Group (C3-CST).
Consorci Sanitari de Terrassa