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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Inhibitory Control - Stroop Task Interference Effect
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The age range is from 18 to 30 years old, meeting the clinical diagnostic criteria for adult ADHD (DSM-5);
- •Diagnosed by a psychiatrist or clinical psychologist using standardized assessment tools (Adult ADHD Self-Rating Scale ASRS-5, Conners Adult ADHD-DIVA-5 Diagnostic Interview), and meeting the clinical diagnostic criteria for adult ADHD (DSM-5);
- •Not taking stimulant drugs to ensure that the symptom assessment is not influenced by the drugs;
排除标准
- •Neurological disorders: such as brain injury, epilepsy, multiple sclerosis, etc., which may affect motor functions;
- •Orthopedic or musculoskeletal disorders: such as severe arthritis, muscle disorders, vestibular dysfunction, etc.;
- •Comorbid mental disorders: such as schizophrenia, bipolar disorder, severe depression or anxiety disorder;
- •Other interfering factors: such as severe visual or hearing impairments, history of alcohol or drug dependence, etc.
结局指标
主要结局
Inhibitory Control - Stroop Task Interference Effect
时间窗: Baseline, Week 4, Week 8
Change in inhibitory control measured by the Stroop interference effect (mean reaction time for incongruent trials minus congruent trials) on the Stroop color-word task. Smaller interference effects indicate better inhibitory control.Unit of Measure: Milliseconds (ms)
Dynamic Balance - Y-Balance Test Left Posterolateral Reach Distance
时间窗: Baseline, Week 4, Week 8
Change in dynamic balance measured by the normalized reach distance (%) of the left leg in the posterolateral direction on the Y-Balance Test. Reach distance is normalized to leg length. Longer reach distances indicate better dynamic balance.
ADHD Core Symptom Severity
时间窗: Baseline, Week 4 (mid-intervention), Week 8 (post-intervention)
Change in ADHD core symptoms assessed by the Adult ADHD Self-Report Scale (ASRS). The ASRS is an 18-item self-report questionnaire measuring inattention and hyperactivity-impulsivity symptoms over the past week. Total scores range from 0 to 72, with higher scores indicating greater symptom severity.Score on a scale (0-72)
Working Memory - N-back Task Accuracy
时间窗: Baseline, Week 4 (mid-intervention), Week 8 (post-intervention)
Change in working memory performance measured by accuracy (%) on the N-back task. Participants respond when the current stimulus matches the one presented N trials earlier. Higher accuracy indicates better working memory.Unit of Measure:Percentage (%)
Prefrontal Cortex Activation
时间窗: Baseline (pre-intervention), Week 8 (post-intervention)
Change in prefrontal cortex hemodynamic response measured by functional near-infrared spectroscopy (fNIRS) during cognitive tasks (N-back and emotional Stroop). Primary outcomes include oxygenated hemoglobin (HbO) concentration changes in the dorsolateral prefrontal cortex (DLPFC) and orbitofrontal cortex (OFC).
Cognitive Flexibility - Wisconsin Card Sorting Test Perseverative Errors
时间窗: Baseline, Week 4, Week 8
Change in cognitive flexibility measured by the number of perseverative errors on the Wisconsin Card Sorting Test (WCST). Perseverative errors occur when participants persist with an incorrect sorting rule despite negative feedback. Fewer perseverative errors indicate better cognitive flexibility.Unit of Measure: Number of errors
Cognitive Flexibility - Wisconsin Card Sorting Test Categories Completed
时间窗: Baseline, Week 4, Week 8
Change in cognitive flexibility measured by the number of categories completed on the Wisconsin Card Sorting Test (WCST). A maximum of 6 categories can be completed. More categories completed indicate better cognitive flexibility.Unit of Measure: Number of categories
Inhibitory Control - Stroop Task Accuracy
时间窗: Baseline, Week 4, Week 8
Change in inhibitory control measured by accuracy (%) across all trial types on the Stroop color-word task. Higher accuracy indicates better performance.Unit of Measure:Percentage (%)
Affective Decision-Making - Iowa Gambling Task Net Score
时间窗: Baseline, Week 4, Week 8
Change in affective decision-making measured by the net score (total advantageous selections minus total disadvantageous selections) on the modified Iowa Gambling Task. Higher net scores indicate better risk-adjusted decision-making.Unit of Measure:Net score
Affective Decision-Making - Iowa Gambling Task Reaction Time
时间窗: Baseline, Week 4, Week 8
Change in affective decision-making measured by mean reaction time (milliseconds) across all trials on the modified Iowa Gambling Task. Shorter reaction times indicate faster decision-making.Unit of Measure: Milliseconds (ms)
Emotional Interference Control - Emotional Stroop Task Interference Effect
时间窗: Baseline, Week 4, Week 8
Change in emotional interference control measured by the emotional Stroop interference effect (mean reaction time for negative/emotional words minus neutral words). Larger interference effects indicate greater emotional distractibility.Unit of Measure:Milliseconds (ms)
Emotional Interference Control - Emotional Stroop Task Accuracy
时间窗: Baseline, Week 4, Week 8
Change in emotional interference control measured by accuracy (%) across all trial types on the emotional Stroop task. Higher accuracy indicates better performance.Unit of Measure:Percentage (%)
Functional Balance - Berg Balance Scale Total Score
时间窗: Baseline, Week 4, Week 8
Change in functional balance measured by the Berg Balance Scale (BBS) total score. The BBS assesses ability to maintain balance during 14 daily activities (e.g., sitting, standing, reaching, turning). Total scores range from 0 to 56. Higher scores indicate better balance performance.
Gait Performance - Functional Gait Assessment Total Score
时间窗: Baseline, Week 4, Week 8
Change in complex gait performance measured by the Functional Gait Assessment (FGA) total score. The FGA evaluates gait during 10 tasks (e.g., walking with head turns, stepping over obstacles, walking backward). Total scores range from 0 to 30. Higher scores indicate better gait performance.
Dynamic Balance - Y-Balance Test Right Anterior Reach Distance
时间窗: Baseline, Week 4, Week 8
Change in dynamic balance measured by the normalized reach distance (%) of the right leg in the anterior direction on the Y-Balance Test. Reach distance is normalized to leg length. Longer reach distances indicate better dynamic balance.
Dynamic Balance - Y-Balance Test Right Posteromedial Reach Distance
时间窗: Baseline, Week 4, Week 8
Change in dynamic balance measured by the normalized reach distance (%) of the right leg in the posteromedial direction on the Y-Balance Test. Reach distance is normalized to leg length. Longer reach distances indicate better dynamic balance.
Dynamic Balance - Y-Balance Test Right Posterolateral Reach Distance
时间窗: Baseline, Week 4, Week 8
Change in dynamic balance measured by the normalized reach distance (%) of the right leg in the posterolateral direction on the Y-Balance Test. Reach distance is normalized to leg length. Longer reach distances indicate better dynamic balance.
Dynamic Balance - Y-Balance Test Left Anterior Reach Distance
时间窗: Baseline, Week 4, Week 8
Change in dynamic balance measured by the normalized reach distance (%) of the left leg in the anterior direction on the Y-Balance Test. Reach distance is normalized to leg length. Longer reach distances indicate better dynamic balance.
Dynamic Balance - Y-Balance Test Left Posteromedial Reach Distance
时间窗: Baseline, Week 4, Week 8
Change in dynamic balance measured by the normalized reach distance (%) of the left leg in the posteromedial direction on the Y-Balance Test. Reach distance is normalized to leg length. Longer reach distances indicate better dynamic balance.
Limb Asymmetry - Y-Balance Test Anterior Asymmetry Index
时间窗: Baseline, Week 4, Week 8
Change in inter-limb coordination measured by the anterior asymmetry index (%) on the Y-Balance Test. The index is calculated as the absolute difference between right and left anterior reach distances divided by the average of both legs. Lower asymmetry indicates better bilateral coordination.
Limb Asymmetry - Y-Balance Test Posteromedial Asymmetry Index
时间窗: Baseline, Week 4, Week 8
Change in inter-limb coordination measured by the posteromedial asymmetry index (%) on the Y-Balance Test. The index is calculated as the absolute difference between right and left posteromedial reach distances divided by the average of both legs. Lower asymmetry indicates better bilateral coordination.
Limb Asymmetry - Y-Balance Test Posterolateral Asymmetry Index
时间窗: Baseline, Week 4, Week 8
Change in inter-limb coordination measured by the posterolateral asymmetry index (%) on the Y-Balance Test. The index is calculated as the absolute difference between right and left posterolateral reach distances divided by the average of both legs. Lower asymmetry indicates better bilateral coordination.
Postural Stability - Biodex Overall Stability Index
时间窗: Baseline, Week 4, Week 8
Change in static postural stability measured by the Overall Stability Index from the Biodex Balance System. The index quantifies the variance of foot platform displacement in degrees. Lower scores indicate better stability.Unit of Measure: Degrees (°)
Dynamic Postural Control - Biodex Limits of Stability Completion Time
时间窗: Baseline, Week 4, Week 8
Change in dynamic postural control measured by the completion time (seconds) on the Limits of Stability test of the Biodex Balance System. Participants move their center of gravity to targets in 8 directions. Shorter completion times indicate better dynamic control.Unit of Measure:Seconds (s)
Dynamic Postural Control - Biodex Limits of Stability Directional Control
时间窗: Baseline, Week 4, Week 8
Change in dynamic postural control measured by the directional control score (%) on the Limits of Stability test of the Biodex Balance System. Higher percentages indicate more efficient movement of the center of gravity toward targets.Unit of Measure:Percentage (%)
次要结局
- Weight(Baseline)
- Anxiety Symptoms(Baseline, Week 4 (mid-intervention), Week 8 (post-intervention))
- Depressive Symptoms(Baseline, Week 4 (mid-intervention), Week 8 (post-intervention))
- Self-Esteem Level(Baseline, Week 4 (mid-intervention), Week 8 (post-intervention))
- Motor Coordination Difficulties(Baseline, Week 4 (mid-intervention), Week 8 (post-intervention))
- ADHD-Specific Quality of Life(Baseline, Week 4 (mid-intervention), Week 8 (post-intervention))
- Prefrontal Cortex Activation (Exploratory)(Baseline (pre-intervention), Week 8 (post-intervention))
- Age(Baseline)
- Height(Baseline)
研究者
Yang Liu
Principal Investigator
Beijing Normal University