Study protocol: a randomized controlled trial study on the effect of a game-based exercise training program on promoting physical fitness and mental health in children with autism spectrum disorder

BACKGROUND: Suboptimal physical activity levels and tolerance, poor motor skills and poor physical health are demonstrated in children with Autism Spectrum Disorder (ASD). We speculate that social interaction and communication deficits in children with ASD are two major factors that hinder these children from actively participating in group physical activities. While previous studies have demonstrated that exercise intervention improves motor skills and behavioral outcomes in children with ASD, these programs tend to focus only on a single sport, which may not cater to the interests of different children with ASD. In this protocol, a game-based exercise training program designed by a multi-disciplinary team (pediatrics, physical education and psychology) will be implemented by front-line healthcare providers trained following the train-the-trainer (TTT) model and subjected to validation. METHOD: Using a randomized controlled trial design, the effectiveness of the game-based exercise program will be examined for 112 young children with ASD. These children were randomly assigned to two groups, which will be tested and trained in either one of the two arms of the waitlist conditions (control and intervention). The assessment of physical and psychological traits will be conducted at baseline (pre-test), at 16-weeks (post-treatment) and at 32-weeks (follow-up) of the program. DISCUSSION: Most of the interventions designed for ASD children target either their psychological traits or physical conditions, without bridging the two states. With the recognition of bidirectional relations between mental and physical health, the present game-based exercise program which includes multiple level of difficulties was developed to equip ASD children with the necessary skills for engaging in sustainable team sports or even professional sport training. The program, if effective, will provide an entertaining and engaging training for whole-person development among children with ASD. TRIAL REGISTRATION: This study is registered with the Chinese Clinical Trial Registry (ChiCTR-IOR-17011898). Registered 6(th) July 2017.