The use of virtual rehabilitation Augmented Reality (AR) exergames for patients with osteoporosis to improve balance, muscle strength and confidence: Study design for a clinical trial.

Osteoporosis is a major bone disease, affecting more than 200 million people globally. Physical exercise is a powerful non-pharmaceutical fracture prevention strategy for people with osteoporosis or those at risk of falls. However, the participation in and adherence to an exercise regimen by older adults is often low due to a lack of motivation, a fear of falling, safety and/or cost. Despite the potential of Augmented Reality (AR) exergames to enhance engagement, motivation, and accessibility in rehabilitation, there is a notable lack of clinical research on their use for osteoporosis management. This study protocol details a partially randomised controlled clinical trial investigating the feasibility and effectiveness of AR-exergames for osteoporosis rehabilitation. We designed four exergames using AR and a body-tracking camera, providing real-time feedback. Based on power analysis, a total of 50 participants were expected after satisfying the inclusion criteria. Forty-eight women (aged 60-86) were enrolled and assigned to the control/intervention training groups. Participants assessment at baseline and at the end of the 6-weeks training included muscle strength, flexibility, balance and pain. This clinical trial is designed to evaluate whether novel AR exergame-based training has significantly greater effects on physical (i.e., muscle strength, balance, flexibility) and affective (i.e., pain) outcomes compared to traditional training programmes. Findings from this trial provide critical insights into the feasibility and effectiveness of immersive, technology-enhanced rehabilitation for osteoporosis management. Key lessons highlight the importance of diverse recruitment strategies, flexible yet structured scheduling, and efficient resource allocation to improve trial efficiency and participant engagement in future studies.