A cybercycling intervention to improve behavioral regulation and classroom functioning among children with behavioral health disorders: Pragmatic randomized trial design for Manville Moves.

While positive and clinically meaningful effects of exercise on cognition and behavior in children have been demonstrated in controlled experimental settings, they have rarely been translated and rigorously evaluated in real-world environments. In particular, there is a lack of research on school-based approaches to sustainable physical activity and exercise interventions targeting children with behavioral health disorders. Manville Moves is an exercise intervention designed to improve behavioral regulation and classroom functioning among children with neurodevelopmental and affective disorders within a therapeutic day-school environment. The curriculum is built around virtual-reality exergaming bicycles (cybercycles) and integrated into physical education (PE) classes. Manville Moves was developed using community based participatory research (CBPR) and implemented as a pragmatic trial. In this paper, we describe (a) the background, theoretical framework and intervention setting, (b) the Manville Moves curriculum, (c) the study design and outcome and process measures, and (d) the strategies used to support implementation compliance and intervention uptake by a population with a variety of behavioral challenges. We conclude with a detailed description of the participatory process by which the intervention was developed and integrated into school programming and a review of the program's key innovations and approaches to addressing threats to internal and external validity.