The Exercogs® Study

NCT07530315 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-04-15

No results posted yet for this study

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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07530315 on ClinicalTrials.gov