The Exercogs® Study
NCT07530315 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2026-04-15
Summary
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.
Conditions
Interventions
- OTHER
-
Exercogs®
The Exercogs® interevention 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.
- OTHER
-
Control
Participants in the control intervention, 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.
Sponsors & Collaborators
-
Value for Health CoLAB
collaborator OTHER -
Instituto de Sistemas e Robótica do Instituto Superior Técnico
collaborator UNKNOWN -
Istituto da Segurança Social - ISS
collaborator UNKNOWN -
Irmãs Hospitaleiras - Casa de Saúde da Idanha
collaborator UNKNOWN -
Eduarda Oliosi, MS
lead OTHER
Principal Investigators
-
Carla Pombo · Irmãs Hospitaleiras | Sintra
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-01
- Primary Completion
- 2026-08-31
- Completion
- 2027-12-31
Countries
- Portugal
Study Locations
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