The Exercogs® Study

NCT07530315 | Recruiting

• 1 other identifier: Exercogs
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Dementia

Keywords

dementia prevention; exergaming; augmented reality; cognitive training; multidomain intervention; healthy aging

Outcome Measures

Primary Outcomes (3)

• Global cognitive function (MoCA total score, points)

  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.

  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 (SPPB total score, points)

  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.

  From baseline to week 24, with assessments at baseline, week 12, week 24 (end of intervention), and at 4 and 8 weeks post-intervention.

• Social participation (WHODAS 2.0 total score, points)

  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.

  From baseline to week 24, with assessments at baseline, week 12, week 24 (end of intervention), and at 4 and 8 weeks post-intervention.

Secondary Outcomes (5)

• 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).

Study Arms (2)

Exercogs®

EXPERIMENTAL

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.

Other: Exercogs®

Control

ACTIVE COMPARATOR

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.

Other: Control

Interventions

Exercogs® OTHER

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.

Exercogs®

Control OTHER

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.

Control

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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®.

Sponsors & Collaborators

• Eduarda Oliosi, MS: lead
• Value for Health CoLAB: collaborator
• Instituto de Sistemas e Robótica do Instituto Superior Técnico: collaborator
• Istituto da Segurança Social - ISS: collaborator
• Irmãs Hospitaleiras - Casa de Saúde da Idanha: collaborator

Study Sites (1)

Irmãs Hospitaleiras - Casa de Saúde da Idanha

Sintra, Portugal

RECRUITING

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Carla Pombo

  Irmãs Hospitaleiras | Sintra

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carla Pombo (Coordinator Nurse and Principal Investigator)

CONTACT

+351 214 339 400; carla.pombo@irmashospitaleiras.pt

Eduarda Oliosi (Biomedical Scientist)

CONTACT

eduarda.oliosi@vohcolab.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Biomedical Scientist at Exercogs study

Model Details: Participants will be randomly assigned to one of two study arms: (A) Exercogs®, a digital multidomain preventive intervention combining AR and gamification; or (B) an active, dose-equivalent control receiving a conventional multidomain program that includes physical, cognitive, and social training without AR or gamification.

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 15, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)