Cognitive-Motor Exergame Training in Frail Adults

NCT07074639 | Recruiting DMC

• 1 other identifier: S.M.A.R.T.
• Study Type: interventional
• Target: 344
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aging; Frailty

Keywords

Frailty; Aging; Cognitive training; Physical activity; Home-based intervention; exergames; dual-task training; fall-prevention

Outcome Measures

Primary Outcomes (1)

• Balance

  The primary outcome measure is balance, which will be assessed by using Berg Balance Scale (BBS). Balance is the ability to maintain stability and control of the body during everyday activities or movements, encompassing both static and dynamic balance. By focusing on balance, the aim is to gain insights into frail adults' ability to remain autonomous and prevent or slow down further frailty-related decline. The BBS has been selected for its proven reliability and validity in assessing balance and predicting fall risk in this population. BBS is a quantitative tool used to assess a patient's ability, or inability, to maintain balance safely during a series of predetermined activities. The scale consists of 14 items, each rated on a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of functional ability and 4 representing the highest.

  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 Outcomes (24)

• Dynamic balance

  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

  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

  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

  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

  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.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants in the IG will receive personalized cognitive-motor training in their home environment. The simultaneous cognitive-motor training in this study will be delivered using the exergame platform "Senso Flex" by Dividat (Dividat AG, Schindellegi, Switzerland). The first session will be supervised by an investigator. Afterwards, participants will continue the training independently at home, with remote supervision and guidance. Participants will be recommended to train 5 times per week for 30 minutes in each session over a 12-week period. Weekly game play will be 150 min to help ensure equal doses of training between IG and CG. The training plan for each participant will be tailored to ensure a progressive and personalized approach. Besides, participants of the intervention group will participate in 3 assessment sessions: (1) T1 (baseline assessments), (2) T2 (post-intervention, after training period), (3) T3 (follow-up assessment).

Other: Personalized, home-based motor-cognitive exergame training

Control Group

ACTIVE COMPARATOR

Participants in the CG will receive the evidence-based OEP on fall prevention. Like for the IG, participants of the CG will be recommended to train 5 times per week for 30 minutes in each session. The training will be conducted over a 12-week period, with a total weekly duration of 150 minutes. The first session will be supervised by an investigator. 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. Like the IG, the participants of the control group will also participate in 3 assessment sessions: (1) T1 (baseline assessments), (2) T2 (post-intervention, after training period), (3) T3 (follow-up assessment).

Other: Otago Exercise Program

Interventions

Personalized, home-based motor-cognitive exergame training OTHER

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), memory (Cognition B), response inhibition (Cognition C), choice reaction time (Cognition D) and task switching (Cognition E). The four sub-domains of balance are mediolateral weight-shifting (Balance A), multidimensional weight-shifting (Balance B), free walking/stepping (Balance C) and mediolateral stepping (Balance D). The training sessions will be personalized in terms of difficulty level.

Intervention Group

Otago Exercise Program OTHER

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 as lower limb strength, balance, and flexibility. It features step-by-step instructions, illustrations, and tips to ensure exercises are performed safely and effectively.

Control Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eleftheria Giannouli: lead

Study Sites (1)

Institute of Human Movement Sciences and Sport, ETH Zürich

Zurich, 8093, Switzerland

RECRUITING

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Jaggi S, Wachter A, Adcock M, de Bruin ED, Moller JC, Marks D, Schweinfurther R, Giannouli E. Feasibility and effects of cognitive-motor exergames on fall risk factors in typical and atypical Parkinson's inpatients: a randomized controlled pilot study. Eur J Med Res. 2023 Jan 16;28(1):30. doi: 10.1186/s40001-022-00963-x.

  PMID: 36647177 BACKGROUND

• Altorfer P, Adcock M, de Bruin ED, Graf F, Giannouli E. Feasibility of Cognitive-Motor Exergames in Geriatric Inpatient Rehabilitation: A Pilot Randomized Controlled Study. Front Aging Neurosci. 2021 Nov 29;13:739948. doi: 10.3389/fnagi.2021.739948. eCollection 2021.

  PMID: 34912206 BACKGROUND

MeSH Terms

Conditions

Frailty; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Eleftheria Giannouli, PhD

  ETH Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eleftheria Giannouli, PhD

CONTACT

+41 44 633 90 58; eleftheria.giannouli@hest.ethz.ch

Asli Karamanlargil, M.Sc.

CONTACT

+41 44 633 08 52; asli.karamanlargil@hest.ethz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study is a single-blind (assessor blind) international, pragmatic, two-arm randomized controlled trial (RCT) conducted in five countries/trial sites: ETH Zurich/University Hospital Zurich (Zurich, Switzerland), Don Carlo Gnocchi Foundation (Milan, Italy), Alma Mater Europaea University/General Hospital Izola (Koper/Izola, Slovenia), Materia Agecare (Nicosia, Cyprus), and Saint Vincent De Paul long term care facility (Luqa, Malta). The study has an intervention group (IG) and a control group (CG) and will consist of 12 weeks of intervention with 12 weeks of follow-up period.

Study Record Dates

• First Submitted: June 15, 2025
• First Posted: July 20, 2025
• Study Start: June 16, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

CH (1)