Effects of open- versus closed-skill exercise combined with mindfulness training on inhibitory control in children with ADHD: protocol for a three-arm randomised controlled trial with fMRI.

内容摘要

Impaired inhibitory control is a core neurocognitive deficit in children with attention deficit hyperactivity disorder (ADHD). Physical exercise and mindfulness training are each promising non-pharmacological approaches for ADHD; however, whether combining mindfulness with different exercise modalities, particularly team-based and individual-based open-skill exercise versus closed-skill exercise, yields differential effects on inhibitory control and its neural substrates remains unknown. This study aims to compare these intervention approaches in children with ADHD while exploring associated neural correlates. This is a single-centre, assessor-blinded and statistician-blinded, three-arm parallel-group randomised controlled trial. 60 children with ADHD aged 6-8 years will be randomly assigned (1:1:1) to one of three 8-week intervention groups: (1) team-based open-skill exercise (basketball) combined with mindfulness training, (2) individual-based open-skill exercise (badminton) combined with mindfulness training or (3) closed-skill exercise (structured aerobic activity) combined with mindfulness training. The co-primary outcomes are behavioural inhibitory control, assessed using the Go/No-Go task and Stroop Colour-Word Test at baseline, postintervention and 3-month follow-up. Secondary outcomes include attention, ADHD symptom severity, executive function, health-related quality of life and resting-state functional MRI indices. This trial has received ethical approval from the Ethics Committee of the Affiliated Changzhou Children's Hospital of Nantong University (Approval No.: 2024-029; Approval Date: 2 January 2025) and will be conducted in accordance with the Declaration of Helsinki (2024 revision). The protocol has been prospectively registered with the Chinese Clinical Trial Registry. Findings will be disseminated through peer-reviewed publications and academic conferences. ChiCTR2500108809.