Cognitive-Motor Exergame Training in Frail Adults (SMART)

Eleftheria Giannouli

Status: Enrolling

Conditions: Aging; Frailty

Treatments: Other: Personalized, home-based motor-cognitive exergame training; Other: Otago Exercise Program

Study type: Interventional

Funder types: Other

Identifiers

NCT07074639

S.M.A.R.T.

Details and patient eligibility

About

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.

Full 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.

Enrollment: 344 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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344 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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).

Treatment:

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

Control Group

Active Comparator group

Description:

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).

Treatment:

Other: Otago Exercise Program