Exercogs®: Efficacy of a Multidomain Digital Therapeutic Solution for Preventing Cognitive Decline in Adults Aged ≥55 With Modifiable Risk Factors - Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Global cognitive function (MoCA total score, points)
研究概览
简要总结
Background: Multidomain, technology-based interventions represent a promising approach to dementia prevention by simultaneously targeting cognitive, physical, and social domains. Exercogs® is a novel exergaming platform combining augmented reality (AR) and gamification, designed to deliver tailored, interactive, and multidomain training. This study aims to evaluate the feasibility, safety, and efficacy of Exercogs® when implemented as part of a community-based dementia prevention program for older adults at risk.
Methods: This is a randomized, controlled, assessor-blind, parallel-group, multicenter trial. One hundred and fifty community-dwelling adults, aged 55 years or older, with at least one modifiable dementia risk factor, will be randomly assigned (1:1) to either the Exercogs® intervention group or the active control group. Both groups will complete 60-minute supervised sessions three times per week for 24 weeks. The Exercogs® program integrates cognitive (e.g., attention, memory, and executive function), physical (e.g., balance, gait, and coordination), and social (e.g., cooperative and competitive) activities within a gamified AR environment. The difficulty levels are adaptable to the participants' individual abilities. The control group will perform equivalent non-AR exercises, i.e., the control group will receive a conventional multidomain group program with the same frequency and duration. Outcomes will be assessed at baseline, 12 weeks, 24 weeks (end of intervention), and 4 and 8 weeks post-intervention. The co-primary endpoints are changes in global cognition (Montreal Cognitive Assessment-Portuguese Version, MoCA-PT), physical performance (Short Physical Performance Battery, SPPB), and social participation (World Health Organization Disability Assessment Schedule, WHODAS 2.0). Secondary outcomes include usability (System Usability Scale, SUS-PT; Exercogs® group only), health-related quality of life (EQ-5D-5L), safety (adverse events, including falls, dizziness, and fatigue), and changes in modifiable risk load. Exploratory outcomes include digital engagement and in-game performance metrics automatically captured by the Exercogs® platform. Feasibility will be assessed by session adherence (≥70% completion).
Results: The protocol has been approved by the Casa de Saúde da Idanha Ethics Committee (Nº6/2025) and funded by the Instituto da Segurança Social, I.P. Preliminary findings are expected in 2026 and will provide comprehensive evidence on the efficacy, feasibility, usability, and safety of Exercogs® as a multidomain digital intervention.
Conclusions: This trial will evaluate a scalable, technology-driven, multidomain intervention for older adults at risk of dementia, integrating cognitive, physical, and social training within an AR environment and gamification. If effective, Exercogs® could serve as a model for community-based dementia prevention and inform public health strategies for healthy aging.
详细描述
Background:
Age-related cognitive decline is a major public health challenge, increasingly burdening healthcare and social protection systems. Large-scale multidomain trials, including FINGER, MAPT, and preDIVA, have shown that multicomponent interventions are more effective in reducing dementia risk than single-domain approaches. The latest Lancet Commission identified 14 modifiable risk factors accounting for up to 45% of potentially preventable dementia cases, highlighting the importance of coordinated prevention strategies. Recent research also emphasizes the role of social and structural determinants, such as socioeconomic factors, HIV infection, and gender, in expanding the global applicability of prevention models. Notably, evidence suggests that multidomain interventions may benefit individuals irrespective of genetic risk.
Given dementia's multifactorial etiology, multidomain interventions are particularly well-suited to address interrelated risk factors, including physical inactivity, social isolation, and cognitive underuse, by simultaneously targeting biological, behavioral, and psychosocial determinants of cognitive aging. Advances in digital health technologies have expanded the reach and feasibility of such programs. Digital tools, including computerized cognitive training and exergaming, have shown promise in improving cognition, physical function, and social engagement among older adults. Extended reality technologies, including virtual and augmented reality (AR), further enhance these interventions by providing immersive, interactive, and adaptive environments that improve motivation, adherence, and learning.
Integrating gamification into AR-based exergames can transform solitary exercises into socially engaging activities, supporting mood, social interaction, and psychological well-being. Systematic reviews confirm benefits across cognitive, physical, and emotional domains, including memory, attention, executive function, mobility, balance, strength, and overall functional capacity. Social (multiplayer) exergames, in particular, offer engaging experiences that support aerobic exercise and enhance social well-being, including reduced loneliness, increased social connection, and more positive attitudes toward others. Feasibility studies further indicate high acceptability, safety, and applicability in home and community settings, with minimal spatial requirements. Nevertheless, while AR-based interventions appear effective, small sample sizes and high heterogeneity limit the generalizability of current findings, emphasizing the need for larger, more standardized trials.
Despite promising preliminary evidence, rigorous trials evaluating AR-based gamified interventions in community-dwelling older adults remain scarce, particularly those assessing multidomain outcomes spanning cognitive, physical, and social dimensions. There is also a need to systematically examine engagement, usability, and real-world applicability to ensure that such interventions can be feasibly scaled and adapted to individual abilities. Delivering a multidomain program through a gamified AR platform could provide an engaging, adaptive, and scalable approach to enhancing cognitive, physical, and social functioning in older adults at risk of cognitive decline. Accordingly, this trial aims to evaluate the efficacy and safety of a gamified AR-based multidomain intervention (Exercogs®) on global cognition, physical performance, and social participation (MoCA, SPPB, WHODAS 2.0).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will be blinded to group allocation, while participants and therapists cannot be blinded due to the nature of the intervention. All participants and therapists will be instructed not to disclose allocation to assessors, and any unblinding events will be recorded and addressed in the analysis.
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 55 years or older
- •Presence of ≥1 modifiable risk factor according to the Lancet Commission on Dementia Prevention, Intervention, and Care (2024): low education, untreated hearing or visual loss, hypertension, obesity, smoking, depression, physical inactivity, type 2 diabetes, social isolation, excessive alcohol consumption, history of head trauma, air pollution exposure, high LDL/dyslipidemia; additional social and structural determinants, including poverty, income inequality, wealth shocks, and HIV, that may also contribute to risk (Mostert et al., 2025);
- •Ability and willingness to participate in 60-minute sessions, three times per week, during the 24-week intervention period;
- •Ability to provide written informed consent, or, in cases of reduced decisional capacity, provision of consent by a legally authorized representative.
排除标准
- •Clinical diagnosis of Alzheimer's disease or dementia;
- •Severe neurological disorder or unstable medical condition that may interfere with participation;
- •Sensory or language deficits that would prevent understanding of instructions or safe participation;
- •Current participation in another interventional study that may confound outcomes (e.g., cognitive training, physical exercise, or multidomain rehabilitation);
- •Previous experience with Exercogs®.
研究组 & 干预措施
Exercogs®
Participants will undertake structured 60-minute sessions three times per week for 24 weeks. Each session integrates physical training (balance, gait, and coordination exercises), cognitive stimulation (attention, memory, and executive functions), and social engagement activities (cooperative and competitive tasks). All activities are delivered within a gamified AR environment designed to enhance engagement and adapt difficulty to individual abilities. The intervention follows a predefined, progressive protocol tailored to each participant's performance.
干预措施: Exercogs® (Other)
Control
Participants will engage in a conventional multidomain program matched for frequency and duration (60 minutes, three times per week, 24 weeks), comprising standard physical, cognitive, and social exercises without AR or gamification.
干预措施: Control (Other)
结局指标
主要结局
Global cognitive function (MoCA total score, points)
时间窗: From baseline to week 24, with assessments at baseline, week 12, week 24 (end of intervention), and at 4 and 8 weeks post-intervention.
Global cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). Total scores range from 0 to 30 points, with higher scores indicating better cognitive performance.
Physical performance (SPPB total score, points)
时间窗: From baseline to week 24, with assessments at baseline, week 12, week 24 (end of intervention), and at 4 and 8 weeks post-intervention.
Physical performance will be measured using the Short Physical Performance Battery (SPPB). Total scores range from 0 to 12 points, with higher scores indicating better lower extremity function.
Social participation (WHODAS 2.0 total score, points)
时间窗: From baseline to week 24, with assessments at baseline, week 12, week 24 (end of intervention), and at 4 and 8 weeks post-intervention.
Functioning and social participation will be assessed using the 12-item World Health Organization Disability Assessment Schedule (WHODAS 2.0). Total scores range from 0 to 100 points, with higher scores indicating greater disability.
次要结局
- Usability (SUS total score, points)(At week 24 (end of intervention).)
- Health-related quality of life (EQ-5D-5L utility index)(At week 24 (end of intervention).)
- Number of participants with adverse events (count)(From baseline through week 24, with safety assessments recorded at weeks 1, 12, and 24.)
- Number of modifiable dementia risk factors (count)(From baseline through week 24, with assessments at baseline, week 12, and week 24.)
- Intervention adherence (percentage of completed Exercogs sessions)(From baseline through week 24 (end of intervention).)
研究者
Eduarda Oliosi, MS
Biomedical Scientist at Exercogs study
Value for Health CoLAB