S.M.A.R.T: A Pragmatic Randomised Controlled Trial of Personalized Cognitive-Motor Exergame Training in Frail Community-Dwelling Adults [Registered Report Stage 1 Protocol]

<b>Abstract</b>Physical and cognitive frailty significantly increase the risk of adverse health outcomes in older adults. In the face of rising rehabilitation demands and workforce shortages, scalable and engaging home-based interventions are urgently needed. Cognitive-motor training, which typically integrates cognitive tasks with whole-body movements, has been shown to be particularly effective in improving both mobility and cognitive function compared to traditional methods. Exergames offer a novel, engaging approach to delivering such training, enhancing enjoyment and adherence. 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. Traditional studies often fail to provide adequate guidance for clinical practice, as they focus on determining efficacy under idealized conditions, using rigid protocols and selectively chosen participants. This can lead to overestimated benefits and underestimated harms. Our study aims to generate evidence for the effectiveness of ICT-based, remote cognitive-motor training under real-world conditions, thereby providing valuable insights for both the scientific and healthcare communities.<b>ITEMS:</b>MANUSCRIPT FILESPIRIT checklistData Management PlanAdditional file 3_TIDIER checklist<br><br>