Cognitive-Motor Exergame Training in Frail Adults

Official title

S.M.A.R.T: A Pragmatic Randomised Controlled Trial of Personalized Cognitive-Motor Exergame Training in Frail Community-Dwelling Adults

Overview

This international multicentre pragmatic randomized controlled trial (RCT) aims to evaluate the effectiveness of personalized, home-based cognitive-motor training using exergames in improving cognitive and motor functions in frail adults. A total of 344 frail participants from five European countries will be enrolled. Participants in the intervention group will engage in a personalized exergame program, while the control group will follow the Otago Exercise Program. Both groups will undergo 12 weeks of training. The primary outcome is balance, a critical component of functional independence and fall prevention, and a common denominator affected in both physical and cognitive frailty. Secondary outcomes including cognitive and motor fall-risk factors, fall incidence, cost-effectiveness, and psychosocial outcomes.

Detailed description

The global population is aging rapidly, with those aged 60+ expected to double by 2050. While longevity is increasing due to better healthcare and living conditions, this shift poses major challenges, frailty being a key concern. Affecting 5%-58% of older adults, frailty compromises independence, quality of life, and healthcare systems. It is a dynamic condition marked by vulnerability to stressors and can appear as physical, cognitive, or combined frailty.

Physical frailty is well-studied, often defined by low gait speed, fatigue, weakness, weight loss, and reduced activity, but broader health indicators are also used. Cognitive frailty, recognized more recently, is defined as the co-existence of physical frailty and cognitive impairment without dementia. It may signal early dementia risk and greater susceptibility to adverse outcomes.

A core feature of frailty is balance dysfunction, caused by impairments in sensory, cognitive, and motor systems. This is especially problematic during dual tasks, like walking while talking, where attention is divided. Such deficits increase fall risk and accelerate cognitive and physical decline.

Traditional fall prevention emphasizes strength and balance, often overlooking cognitive factors. Yet, evidence shows that motor and cognitive systems are linked, and dual-task training can enhance both domains. Cognitive-motor training, which integrates cognitively demanding tasks into physical exercises, offers a promising dual-domain intervention by leveraging shared brain networks and promoting neuroplasticity.

While effective, most cognitive-motor programs are delivered in person and rarely tailored to individual frailty profiles. Personalized, home-based programs could offer better results through tailored challenge and engagement. Exergames, interactive digital games with physical and cognitive components, show promise as customizable, engaging tools for such training. However, few have integrated both domains simultaneously in frail adults.

This study aims to assess a 12-week, home-based personalized cognitive-motor training program against the Otago Exercise Program (OEP) in frail older adults. Outcomes include physical and cognitive fall-risk factors, fall incidence, quality of life, and physical activity. The hypothesis is that the personalized cognitive-motor program will lead to greater improvements and may offer an effective, scalable solution to reduce falls and promote independence in this vulnerable population.

Interventions

• Other Personalized, home-based motor-cognitive exergame training
  The simultaneous cognitive-motor training in this study will be delivered using the exergame platform "Senso Flex" by Dividat (Dividat AG, Schindellegi, Switzerland), which is a pressure-sensitive foldable mat that connects to standard televisions (or any big screen). Games will be allocated across three primary domains: cognition (consisting of five sub-domains), balance (consisting of four sub-domains) and endurance. The five sub-domains of cognition are visuospatial orientation (Cognition A),
• Other Otago Exercise Program
  Participants in the CG will receive the evidence-based OEP on fall prevention. The OEP was selected as an active control to mirror usual care in real-world clinical settings and support the pragmatic nature of our study design. The program will be implemented in the form of a booklet, designed to provide a comprehensive guide for improving balance, strength, and overall physical function. Specifically tailored for older adults, the program includes a variety of exercises targeting key areas such

Primary outcome measures

• Balance [Time frame: The primary outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.]

Secondary outcome measures (12)

• Dynamic balance [Time frame: This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.]
• Lower extremity function [Time frame: This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.]
• Functional Mobility and Balance in Single Task [Time frame: This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.]
• Functional Mobility and Balance in Dual-Task [Time frame: This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.]
• Dual-Task Costs [Time frame: This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.]
• Functional capacity [Time frame: This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.]
• Performance Fatigability [Time frame: This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.]
• Response inhibition (reaction time) [Time frame: This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.]
• Response inhibition (error rate) [Time frame: This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.]
• Cognitive flexibility (reaction time) [Time frame: This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.]
• Cognitive flexibility (error rate) [Time frame: This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.]
• Psychomotor Speed [Time frame: This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.]

Eligibility criteria

Inclusion criteria

• 50 years and older
• Fried Frailty Phenotype score 3 or higher and/or MoCA score between 10-25
• Must be able to give informed consent
• Access to internet and a TV/large screen at home

Exclusion criteria

• Mobility limitations (e.g., severe arthritis or lower extremity amputation)
• Cognitive limitations (e.g., advanced Alzheimer's disease, frontotemporal/Lewy body/vascular dementia)
• Sensory limitations (e.g., color-blindness, complete hearing loss and neuropathy causing significant loss of sensation)
• Psychiatric limitations (e.g., acute, or uncontrolled affective disorders)
• Comorbidities that would impair their ability to engage in the training
• Simultaneous participation in other clinical trials/intervention studies
• Inability to understand game instructions and play the games safely, based on judgement of a therapist

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Switzerland · 1 center

• Institute of Human Movement Sciences and Sport, ETH Zürich — Zurich

Publications

• Seinsche J, Kyprianou E, de Bruin ED, Saibene E, Rizzo F, Carpinella I, Lutz L, Ferrarin M, Villa R, Chrysostomou S, Moza S, Giannouli E. Discriminative ability of instrumented cognitive-motor assessments to distinguish fallers from non-fallers. Geroscience. 2025 Feb;47(1):1139-1150. doi: 10.1007/s11357-024-01313-x. Epub 2024 Aug 9. PMID 39120688
• Seinsche J, de Bruin ED, Saibene E, Rizzo F, Carpinella I, Ferrarin M, Ifanger S, Moza S, Giannouli E. Feasibility and Effectiveness of a Personalized Home-Based Motor-Cognitive Training Program in Community-Dwelling Older Adults: Protocol for a Pragmatic Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Nov 9;12:e49377. doi: 10.2196/49377. PMID 37943591
• Rainero I, Summers MJ, Monter M, Bazzani M, Giannouli E, Aumayr G, Burin D, Provero P, Vercelli AE; My-AHA Consortium. The My Active and Healthy Aging ICT platform prevents quality of life decline in older adults: a randomised controlled study. Age Ageing. 2021 Jun 28;50(4):1261-1267. doi: 10.1093/ageing/afaa290. PMID 33480986
• Glatt RM, Patis C, Miller KJ, Merrill DA, Stubbs B, Adcock M, Giannouli E, Siddarth P. The "FitBrain" program: implementing exergaming & dual-task exercise programs in outpatient clinical settings. Front Sports Act Living. 2024 Dec 6;6:1449699. doi: 10.3389/fspor.2024.1449699. eCollection 2024. PMID 39712081
• Seinsche J, de Bruin ED, Saibene E, Rizzo F, Carpinella I, Ferrarin M, Moza S, Ritter T, Giannouli E. A Newly Developed Exergame-Based Telerehabilitation System for Older Adults: Usability and Technology Acceptance Study. JMIR Hum Factors. 2023 Dec 7;10:e48845. doi: 10.2196/48845. PMID 38060283
• Seinsche J, de Bruin ED, Carpinella I, Ferrarin M, Moza S, Rizzo F, Salatino C, Giannouli E. Older adults' needs and requirements for a comprehensive exergame-based telerehabilitation system: A focus group study. Front Public Health. 2023 Jan 11;10:1076149. doi: 10.3389/fpubh.2022.1076149. eCollection 2022. PMID 36711352
• Bernardes RA, Giannouli E, Neves H, Parola V. Editorial: User-centered technology for exercise optimization in older adults. Front Sports Act Living. 2025 Feb 4;7:1558979. doi: 10.3389/fspor.2025.1558979. eCollection 2025. No abstract available. PMID 39968188
• Buttiker J, Marks D, Hanke M, Ludyga S, Marsico P, Eggimann B, Giannouli E. Cognitive-motor exergame training on a labile surface in stroke inpatients: study protocol for a randomized controlled trial. Front Neurol. 2024 Jun 19;15:1402145. doi: 10.3389/fneur.2024.1402145. eCollection 2024. PMID 38966081

Identifiers

NCT: NCT07074639 · S.M.A.R.T.

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗