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

NCT07499427 | Terminated

• 1 other identifier: Beijing Normal University
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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

ADHD - Attention Deficit Disorder With Hyperactivity; ADHD; ADHD - Combined Type; ADHD - Inattentive Type; ADHD Specifically With Executive Function Impairment

Keywords

ADHD

Outcome Measures

Primary Outcomes (25)

• ADHD Core Symptom Severity

  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)

  Baseline, Week 4 (mid-intervention), Week 8 (post-intervention)

• Working Memory - N-back Task Accuracy

  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 (%)

  Baseline, Week 4 (mid-intervention), Week 8 (post-intervention)

• Prefrontal Cortex Activation

  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).

  Baseline (pre-intervention), Week 8 (post-intervention)

• Cognitive Flexibility - Wisconsin Card Sorting Test Perseverative Errors

  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

  Baseline, Week 4, Week 8

• Cognitive Flexibility - Wisconsin Card Sorting Test Categories Completed

  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

  Baseline, Week 4, Week 8

• Inhibitory Control - Stroop Task Interference Effect

  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)

  Baseline, Week 4, Week 8

• Inhibitory Control - Stroop Task Accuracy

  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 (%)

  Baseline, Week 4, Week 8

• Affective Decision-Making - Iowa Gambling Task Net Score

  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

  Baseline, Week 4, Week 8

• Affective Decision-Making - Iowa Gambling Task Reaction Time

  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)

  Baseline, Week 4, Week 8

• Emotional Interference Control - Emotional Stroop Task Interference Effect

  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)

  Baseline, Week 4, Week 8

• Emotional Interference Control - Emotional Stroop Task Accuracy

  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 (%)

  Baseline, Week 4, Week 8

• Functional Balance - Berg Balance Scale Total Score

  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.

  Baseline, Week 4, Week 8

• Gait Performance - Functional Gait Assessment Total Score

  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.

  Baseline, Week 4, Week 8

• Dynamic Balance - Y-Balance Test Right Anterior Reach Distance

  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.

  Baseline, Week 4, Week 8

• Dynamic Balance - Y-Balance Test Right Posteromedial Reach Distance

  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.

  Baseline, Week 4, Week 8

• Dynamic Balance - Y-Balance Test Right Posterolateral Reach Distance

  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.

  Baseline, Week 4, Week 8

• Dynamic Balance - Y-Balance Test Left Anterior Reach Distance

  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.

  Baseline, Week 4, Week 8

• Dynamic Balance - Y-Balance Test Left Posteromedial Reach Distance

  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.

  Baseline, Week 4, Week 8

• Dynamic Balance - Y-Balance Test Left Posterolateral Reach Distance

  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.

  Baseline, Week 4, Week 8

• Limb Asymmetry - Y-Balance Test Anterior Asymmetry Index

  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.

  Baseline, Week 4, Week 8

• Limb Asymmetry - Y-Balance Test Posteromedial Asymmetry Index

  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.

  Baseline, Week 4, Week 8

• Limb Asymmetry - Y-Balance Test Posterolateral Asymmetry Index

  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.

  Baseline, Week 4, Week 8

• Postural Stability - Biodex Overall Stability Index

  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 (°)

  Baseline, Week 4, Week 8

• Dynamic Postural Control - Biodex Limits of Stability Completion Time

  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)

  Baseline, Week 4, Week 8

• Dynamic Postural Control - Biodex Limits of Stability Directional Control

  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 (%)

  Baseline, Week 4, Week 8

Secondary Outcomes (9)

• 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)

Study Arms (3)

Aerobic Treadmill Training Group

ACTIVE COMPARATOR

Participants receive 30-minute moderate-intensity aerobic treadmill training, 3 sessions per week for 8 weeks. Intensity is controlled at 60-75% of heart rate maximum (HRmax) and Borg RPE 12-14. Each session includes warm-up, main exercise, and cool-down.

Behavioral: Aerobic Treadmill Training

Balance Training Group

EXPERIMENTAL

Participants receive 30-minute progressive balance training, 3 sessions per week for 8 weeks. Training progresses from static stance on stable surfaces to dynamic tasks on unstable surfaces, following a structured 3-phase protocol to enhance postural control and proprioception.

Behavioral: Progressive Balance Training

Cognitive-Balance Dual-Task Training Group

EXPERIMENTAL

Participants receive 30-minute dual-task training combining progressive balance exercises with concurrent cognitive tasks (e.g., N-back, mental arithmetic, Stroop), 3 sessions per week for 8 weeks. Cognitive load increases progressively alongside balance difficulty.

Behavioral: Cognitive-Balance Dual-Task Training

Interventions

Aerobic Treadmill Training BEHAVIORAL

Participants 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.

Aerobic Treadmill Training Group

Progressive Balance Training BEHAVIORAL

Participants 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.

Balance Training Group

Cognitive-Balance Dual-Task Training BEHAVIORAL

Participants 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.

Cognitive-Balance Dual-Task Training Group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wuhan Sports University: lead

Study Sites (1)

Beijing Normal University

Beijing, China

Location

Related Publications (2)

• Adamou M, Asherson P, Arif M, Buckenham L, Cubbin S, Dancza K, Gorman K, Gudjonsson G, Gutman S, Kustow J, Mabbott K, May-Benson T, Muller-Sedgwick U, Pell E, Pitts M, Rastrick S, Sedgwick J, Smith K, Taylor C, Thompson L, van Rensburg K, Young S. Recommendations for occupational therapy interventions for adults with ADHD: a consensus statement from the UK adult ADHD network. BMC Psychiatry. 2021 Feb 4;21(1):72. doi: 10.1186/s12888-021-03070-z.

  PMID: 33541313 RESULT

• Faheem M, Akram W, Akram H, Khan MA, Siddiqui FA, Majeed I. Gender-based differences in prevalence and effects of ADHD in adults: A systematic review. Asian J Psychiatr. 2022 Sep;75:103205. doi: 10.1016/j.ajp.2022.103205. Epub 2022 Jul 14.

  PMID: 35878424 RESULT

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: March 30, 2026
• Study Start: October 7, 2025
• Primary Completion: January 25, 2026
• Study Completion: February 15, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)