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Trials / Terminated

TerminatedNCT07499427

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
130 (actual)
Sponsor
Wuhan Sports University · Academic / Other
Sex
All
Age
18 Years – 30 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALAerobic Treadmill TrainingParticipants undergo structured aerobic training on a treadmill for 30 minutes per session, 3 times per week over 8 weeks. Each session includes a 5-minute warm-up (slow walking/jogging), 20 minutes of main exercise, and a 5-minute cool-down. Intensity is maintained at moderate level (60-75% of heart rate maximum, HRmax) monitored by heart rate monitor, and Borg Rating of Perceived Exertion (RPE) scale 12-14 ("somewhat hard" to "hard"). The intervention aims to improve cardiorespiratory fitness and general health.
BEHAVIORALProgressive Balance TrainingParticipants receive progressive balance training for 30 minutes per session, 3 times per week for 8 weeks. Training follows a 3-phase progression: Phase 1 (weeks 1-2): static stance and weight shifting on stable surfaces; Phase 2 (weeks 3-5): dynamic tasks on unstable surfaces (e.g., balance pads, wobble boards) with vestibular challenges; Phase 3 (weeks 6-8): functional multi-task activities (e.g., single-leg stance with trunk rotation, holding objects). Difficulty is manipulated by altering base of support, visual input (eyes open/closed), and task complexity. All sessions are supervised by trained staff. The goal is to enhance static and dynamic balance and proprioceptive function.
BEHAVIORALCognitive-Balance Dual-Task TrainingParticipants undergo the same progressive balance training protocol as the Balance Training Group, but with simultaneous cognitive tasks superimposed throughout each session. Cognitive tasks include: serial subtraction, N-back tasks, alternating arithmetic operations, word generation/categorization, and Stroop tasks. These tasks engage working memory, cognitive flexibility, and attention. Training follows a progressive difficulty principle: initial weeks involve simple cognitive tasks during static balance; later weeks incorporate complex cognitive tasks during dynamic balance challenges. The dual-task interference is systematically increased to optimize cognitive resource allocation and postural control strategies. Sessions are 30 minutes, 3 times per week for 8 weeks, supervised by trained staff.

Timeline

Start date
2025-10-07
Primary completion
2026-01-25
Completion
2026-02-15
First posted
2026-03-30
Last updated
2026-03-30

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07499427. Inclusion in this directory is not an endorsement.