AgingSMARTNCT07074639
Cognitive-Motor Exergame Training in Frail Adults
A study testing Personalized, home-based motor-cognitive exergame training and Otago Exercise Program in people with Aging and Frailty, run by Eleftheria Giannouli at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- What is being tested?
- Personalized, home-based motor-cognitive exergame training and Otago Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Jun 2025to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Institute of Human Movement Sciences and Sport, ETH Zürich
Zurich, 8093
Eleftheria Giannouli, PhD, +41 44 633 90 58, eleftheria.giannouli@hest.ethz.ch
Asli Karamanlargil, M.Sc., +41 44 633 08 52, asli.karamanlargil@hest.ethz.ch
About this study
Official title: S.M.A.R.T: A Pragmatic Randomised Controlled Trial of Personalized Cognitive-Motor Exergame Training in Frail Community-Dwelling Adults
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.
Read the 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.
- Being tested
- Personalized, home-based motor-cognitive exergame training, Otago Exercise Program
- Keywords
- Frailty, Aging, Cognitive training, Physical activity, Home-based intervention, exergames, dual-task training, fall-prevention
- Medical subject headings
- Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized, home-based motor-cognitive exergame trainingOther
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.
Otago Exercise ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Otago Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The Four-Square Step Test (FSST) will be used to measure dynamic balance by timing (in seconds) how long a subject takes to step forward, backward, and sideways through four floor-marked squares in a specific sequence and then reverse back to the starting position.
Measured: 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
Lower extremity function will be evaluated using the Short Physical Performance Battery (SPPB). The SPPB includes three timed tasks: maintaining static balance in three-foot positions, walking 4 meters to assess gait speed, and performing five consecutive sit-to-stand movements. Minimum score: 0, Maximum score: 12.
Higher scores indicating better lower extremity function.
Measured: 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
Functional mobility and balance will be evaluated in single task using the Timed Up and Go (TUG) test. The TUG test measures the time needed to stand up, walk 3 meters at a normal pace, turn, return to the chair, and sit down (in seconds).
Measured: 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
Functional mobility and balance in dual-task will be evaluated using the Timed Up and Go (TUG) test in dual task (DT) conditions - here a cognitive task, in which participants will be instructed to count backwards from 100, subtracting 2 successively, will be added to the main TUG task. Outcome of this test is duration. Higher values indicate lower performance.
Measured: 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
Dual-task cost (DTC) will be calculated using the values of the TUG test in single task and the TUG test in dual-task using the formula:
DTC (%) = [(Single-task performance - Dual-task performance) / Single-task performance] * 10
Measured: 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
The 6-Minute Walk Test (6MWT) will measure functional capacity by recording the distance walked (in meters) at a brisk, self-paced speed over six minutes, reflecting the integrated physiological response of multiple systems.
Measured: 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
Performance fatigability, which objectively captures how physical performance worsens over time, offering insights into endurance and fall risk, is then calculated as the ratio (%) of mean walking speed over six minutes (V6 min) to the mean speed of the first two minutes (V2 min), divided by the total distance (meter) and scaled by 1000 .
Measured: 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)
The go/no-go test measures response inhibition by evaluating (amongst other measures) reaction time (in milliseconds) as participants respond to "go" stimuli and suppress responses to "no-go" stimuli. All cognitive assessments will be conducted using PsyToolkit, an open-source platform widely used for implementing computerized cognitive tasks in research settings.
Measured: 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)
The go/no-go test measures response inhibition by evaluating (amongst other measures) errors as participants respond to "go" stimuli and suppress responses to "no-go" stimuli. All cognitive assessments will be conducted using PsyToolkit, an open-source platform widely used for implementing computerized cognitive tasks in research settings.
Measured: 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)
The multitasking test evaluates cognitive flexibility by requiring participants to switch between shape and filling tasks based on stimulus location, measuring (amongst other measures) reaction time (in milliseconds). All cognitive assessments will be conducted using PsyToolkit, an open-source platform widely used for implementing computerized cognitive tasks in research settings.
Measured: 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)
The multitasking test evaluates cognitive flexibility by requiring participants to switch between shape and filling tasks based on stimulus location, measuring (amongst other measures) errors. All cognitive assessments will be conducted using PsyToolkit, an open-source platform widely used for implementing computerized cognitive tasks in research settings.
Measured: 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
The Deary-Liewald Task assesses (amongst other measures) reaction times (in milliseconds) by measuring participants' responses to stimuli in a simple reaction time task or their ability to select the correct key in a choice reaction time task. All cognitive assessments will be conducted using PsyToolkit, an open-source platform widely used for implementing computerized cognitive tasks in research settings.
Measured: 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 errors
The Deary-Liewald Task assesses (amongst other measures) errors by measuring participants' responses to stimuli in a simple reaction time task or their ability to select the correct key in a choice reaction time task. All cognitive assessments will be conducted using PsyToolkit, an open-source platform widely used for implementing computerized cognitive tasks in research settings.
Measured: 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.
Sustained attention and response inhibition (reaction time)
The sustained attention to response task measures sustained attention and response inhibition by requiring responses to digits from '1' to '9' except for '3', assessing (amongst other measures) reaction time (in milliseconds). All cognitive assessments will be conducted using PsyToolkit, an open-source platform widely used for implementing computerized cognitive tasks in research settings.
Measured: 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.
Sustained attention and response inhibition (error rate)
The sustained attention to response task measures sustained attention and response inhibition by requiring responses to digits from '1' to '9' except for '3', assessing (amongst other measures) errors. All cognitive assessments will be conducted using PsyToolkit, an open-source platform widely used for implementing computerized cognitive tasks in research settings.
Measured: 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.
Fall incidence
Falls will be monitored through detailed records of falls within the past 12 months. Monitoring will involve tracking of fall frequency through regular telephone calls during which participants will be asked to report the number of falls they have experienced since the last contact (conducted weekly for the first three weeks and biweekly thereafter).
Measured: Fall history will be collected at most 1 week prior to starting the intervention. Fall incidence will be collected continuously throughout the intervention, as well as during the 12 weeks post-intervention.
Fear of falling
The Falls Efficacy Scale - International will be used to assess participants' confidence in their ability to avoid falls during different activities. The scale goes from 16 points (minimum value, no fear of falling) to 64 points (maximum value, severe concern about falling).
Measured: 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.
Quality of life parameters
Quality of life will be measured using the EuroQol 5-Dimension 5-Level Questionnaire, which evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Participants will be asked to report the level of difficulties they encounter in these dimensions, choosing from 5 levels (1 being no problems encountered, 5 being extreme problems in this dimension).
Furthermore the EuroQol VAS (visual analog scale) will be used. Participants will rate their health-related quality of life on a scale from 0-100, with the lowest value meaning the worst health state they can imagine, and the highest value meaning the best health state they can imagine.
Measured: 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.
Exergame Enjoyment Questionnaire
The exergame enjoyment questionnaire assesses enjoyment of the exergame intervention at the intervention group (IG). The minimum score is 20 points and the maximum score is 100 points. Higher scores are better, indicating more enjoyment.
Measured: This outcome will be measured at most 1 week after the end of the intervention.
Usability
The System Usability Scale (SUS) will be used to assess usability of the cognitive-motor exergame training system within IG. Higher scores indicate higher usability. The minimum score is 0 points and the maximum score is 100 points. A higher score is better and indicates better usability.
Measured: This outcome will be measured at most 1 week after the end of the intervention.
Adherence
Adherence will be assessed based on the weekly training duration, measured as the total time spent on training each week (in minutes). This data will be recorded and displayed in the rehabilitation cockpit (Dividat Manager system). The adherence rate will be calculated as the number and duration of completed training sessions relative to the recommended number and duration, expressed as a percentage (%). The regular telephone calls will also be used to enhance adherence to the training program. Adherence in the CG will be monitored through regular phone calls, as in the IG, and paper-based training logs, which participants will return at post-intervention assessment visit.
Measured: This outcome will be recorded continuously throughout the intervention period, namely in the weeks 1, 2 , 3, 5, 7, 9, 11, and 12 of the intervention.
Level of assistance
The level of assistance required by the participant, measured in weekly hours of formal or informal caregiving, as well as information related to physical and cognitive activities and interventions will be collected through an ad hoc questionnaire during regular telephone calls, to provide the data needed to perform the cost-effectiveness analysis. The lowest level is "no assistance" and the highest level is "full assistance".
Measured: This outcome will be measured at most 1 week before the intervention starts, then continuously throughout the intervention period and again 12 weeks after the end of the intervention.
Adverse events
Total number of (Serious) Adverse Events (SAE/AE).
Measured: This outcome will be measured starting from at most 1 week before the intervention, throughout the intervention until the final measurement 12 weeks after the end of the intervention.
Attrition rate
Number of drop-outs of patients included in the study.
Measured: This outcome will be measured starting from at most 1 week before the intervention, throughout the intervention until the final measurement 12 weeks after the end of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start16 Jun 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 344 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eleftheria Giannouli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eleftheria Giannouli, Swiss Federal Institute of Technology
- Investigators
- Eleftheria Giannouli, PhD, Principal investigator, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074639
- Sponsor's protocol ID
- S.M.A.R.T.
- Acronym
- SMART
- Status last verified
- Jul 2025
- First submitted
- 15 Jun 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 39120688Seinsche 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.
PubMed 37943591Rainero 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.
PubMed 33480986Glatt 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.
PubMed 39712081Seinsche 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.
PubMed 38060283Seinsche 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.
PubMed 36711352Bernardes 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.
PubMed 39968188Buttiker 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.
PubMed 38966081Jaggi 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.
PubMed 36647177Altorfer 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.
PubMed 34912206
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- S.M.A.R.T: A Pragmatic Randomised Controlled Trial of Personalized Cognitive-Motor Exergame Training in Frail Community-Dwelling Adults
- ClinicalTrials.gov ID
- NCT07074639
- Acronym / sponsor ID
- SMART / S.M.A.R.T.
- Keywords
- Frailty, Aging, Cognitive training, Physical activity, Home-based intervention, exergames, dual-task training, fall-prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 344 participants (estimated)
- Lead sponsor
- Eleftheria GiannouliUniversity, hospital or other
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Personalized, home-based motor-cognitive exergame trainingParticipants 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). |
| Control Group | Active comparator | Other: Otago Exercise ProgramParticipants 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). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized, home-based motor-cognitive exergame trainingThe 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. | Other | Intervention Group |
| Otago Exercise ProgramParticipants 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. | Other | Control Group |
Primary outcome
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.
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.
24 secondary outcomes
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.
Psychomotor errors
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.
Sustained attention and 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.
Sustained attention and 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.
Fall incidence
Time frame: Fall history will be collected at most 1 week prior to starting the intervention. Fall incidence will be collected continuously throughout the intervention, as well as during the 12 weeks post-intervention.
Fear of falling
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.
Quality of life parameters
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.
Exergame Enjoyment Questionnaire
Time frame: This outcome will be measured at most 1 week after the end of the intervention.
Usability
Time frame: This outcome will be measured at most 1 week after the end of the intervention.
Adherence
Time frame: This outcome will be recorded continuously throughout the intervention period, namely in the weeks 1, 2 , 3, 5, 7, 9, 11, and 12 of the intervention.
Level of assistance
Time frame: This outcome will be measured at most 1 week before the intervention starts, then continuously throughout the intervention period and again 12 weeks after the end of the intervention.
Adverse events
Time frame: This outcome will be measured starting from at most 1 week before the intervention, throughout the intervention until the final measurement 12 weeks after the end of the intervention.
Attrition rate
Time frame: This outcome will be measured starting from at most 1 week before the intervention, throughout the intervention until the final measurement 12 weeks after the end of the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Background: PubMed 39120688Seinsche 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.
- Background: PubMed 37943591Seinsche 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.
- Background: PubMed 33480986Rainero 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.
- Background: PubMed 39712081Glatt 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.
- Background: PubMed 38060283Seinsche 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.
- Background: PubMed 36711352Seinsche 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.
- Background: PubMed 39968188Bernardes 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.
- Background: PubMed 38966081Buttiker 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.
- Background: PubMed 36647177Jaggi 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.
- Background: PubMed 34912206Altorfer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eleftheria Giannouli, PhD principal investigator
ETH Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized, home-based motor-cognitive exergame training and Otago Exercise Program in people with Aging and Frailty, run by Eleftheria Giannouli at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eleftheria Giannouli, PhD (+41 44 633 90 58, eleftheria.giannouli@hest.ethz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07074639, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.