Clinical Trial

Research on the Development, Implementation Effect and Neural Mechanism of a Physical Intervention Program for College Students With ADHD Based on the Characteristics of Balance Dysfunction

Terminated
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Why the trial stopped
The first stage of recruitment has ended because all the college students have already taken their winter vacations.
Summary
Background: Attention deficit/hyperactivity disorder is a common neurodevelopmental disorder. Its core symptoms and related executive function, emotional and motor coordination problems often persist into adulthood, significantly affecting the academic performance and quality of life of college students. Current drug interventions have limitations, while exercise interventions, especially training focused on balance ability, show potential in improving cognitive functions, but systematic research on this aspect for the college student population is still insufficient. Research Objectives: This study aims to explore the effects of different exercise intervention models on college students with attention deficit hyperactivity disorder. The main objectives include: The system assessment focuses on the characteristics of college students with attention deficit hyperactivity disorder in terms of core symptoms, executive functions, emotional issues, and balance abilities. Compare the effects of eight-week aerobic training, conventional balance training, and "cognitive-balance dual-task" training on improving the symptoms of attention deficit hyperactivity disorder and cognitive function. By utilizing functional near-infrared spectroscopy technology, we aim to explore the potential brain mechanisms (such as changes in activation of the prefrontal cortex) through which exercise intervention can improve attention deficit hyperactivity disorder. Participants: This study will recruit college students who meet the diagnostic criteria for attention deficit hyperactivity disorder as the experimental group, and at the same time recruit healthy college students of the same age and gender as the control group. Research Design: This study consists of three parts: Study 1 (Cross-sectional Comparison): To compare the baseline differences in symptoms, cognition, emotions, and balance ability between college students with attention deficit hyperactivity disorder and healthy college students. Study Two (Randomized Controlled Trial): College students with attention deficit hyperactivity disorder were randomly assigned to three 8-week (3 times per week) intervention groups: the aerobic treadmill training group, the conventional balance training group, and the cognitive-balance dual-task training group. All participants underwent comprehensive assessments before the intervention, 4 weeks into the intervention, and 8 weeks into the intervention. Study 3 (Exploration of Neural Mechanisms): Before and after the intervention, the functional near-infrared spectroscopy technique was used to detect the activation of the prefrontal cortex in college students with attention deficit hyperactivity disorder when they were performing cognitive tasks. Measurement indicators: The study will use standardized scales to assess the core symptoms of attention deficit hyperactivity disorder, anxiety, depression, self-esteem, and quality of life; use neuropsychological tasks to evaluate "cold" and "hot" executive functions; and use high-precision balance testing systems (such as the Biodex Balance Analyzer, Y Balance Test) to assess postural control and dynamic balance abilities. Expected significance: This study is expected to provide a scientific and effective new non-pharmacological intervention plan for adult attention deficit hyperactivity disorder, and clarify the "brain-behavior" mechanism of the synergistic enhancement of "cognitive-motor" training, providing a theoretical basis for future personalized and mechanism-driven clinical rehabilitation strategies.
Trial Details
NCT Number NCT07499427
Lead Sponsor Wuhan Sports University
Conditions ADHD - Attention Deficit Disorder With Hyperactivity, ADHD, ADHD - Combined Type, ADHD - Inattentive Type, ADHD Specifically With Executive Function Impairment
Enrollment 130 participants
Start Date 2025-10-07
Primary Completion 2026-01-25 (estimated)
Study Completion 2026-02-15 (estimated)
Updated on ClinicalTrials.gov 2026-03-30