ADHD - Attention Deficit Disorder With HyperactivityNCT07499427
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
A study testing Aerobic Treadmill Training, Progressive Balance Training and Cognitive-Balance Dual-Task Training in people with ADHD - Attention Deficit Disorder With Hyperactivity and ADHD, run by Wuhan Sports University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD - Attention Deficit Disorder With Hyperactivity, ADHD, ADHD - Combined Type
- What is being tested?
- Aerobic Treadmill Training, Progressive Balance Training and Cognitive-Balance Dual-Task Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 7 Oct 2025to 15 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Aerobic Treadmill Training, Progressive Balance Training, Cognitive-Balance Dual-Task Training
- Keywords
- ADHD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Treadmill TrainingBehavioural
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.
Progressive Balance TrainingBehavioural
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.
Cognitive-Balance Dual-Task TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Cognitive-Balance Dual-Task Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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 (%)
Measured: 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).
Measured: 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
Measured: 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
Measured: 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)
Measured: 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 (%)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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 (%)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 (°)
Measured: 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)
Measured: 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 (%)
Measured: Baseline, Week 4, Week 8
Secondary outcomes (9)
Anxiety Symptoms
Change in anxiety symptoms assessed by the Generalized Anxiety Disorder 7-item scale (GAD-7). The GAD-7 is a self-report questionnaire measuring anxiety symptoms over the past two weeks. Total scores range from 0 to 21, with higher scores indicating greater anxiety severity.
Measured: Baseline, Week 4 (mid-intervention), Week 8 (post-intervention)
Depressive Symptoms
Change in depressive symptoms assessed by the Patient Health Questionnaire 9-item scale (PHQ-9). The PHQ-9 is a self-report questionnaire measuring depression symptoms over the past two weeks. Total scores range from 0 to 27, with higher scores indicating greater depression severity.
Measured: Baseline, Week 4 (mid-intervention), Week 8 (post-intervention)
Self-Esteem Level
Change in self-esteem assessed by the Rosenberg Self-Esteem Scale (RSES). The RSES is a 10-item self-report scale measuring global self-worth. Scores range from 0 to 30, with higher scores indicating higher self-esteem.
Measured: Baseline, Week 4 (mid-intervention), Week 8 (post-intervention)
Motor Coordination Difficulties
Change in motor coordination assessed by the Adult Developmental Coordination Disorder Questionnaire (DCDQ). The DCDQ is a self-report measure evaluating motor coordination difficulties in daily activities. Total scores range from 15 to 75, with higher scores indicating greater coordination problems.
Measured: Baseline, Week 4 (mid-intervention), Week 8 (post-intervention)
ADHD-Specific Quality of Life
Change in quality of life assessed by the Adult ADHD Quality of Life measure (AAQoL-29). The AAQoL-29 is a 29-item self-report questionnaire measuring life productivity, psychological health, relationships, and life outlook. Total scores range from 29 to 145, with higher scores indicating better quality of life.
Measured: Baseline, Week 4 (mid-intervention), Week 8 (post-intervention)
Prefrontal Cortex Activation (Exploratory)
Change in prefrontal cortex hemodynamic response measured by functional near-infrared spectroscopy (fNIRS) during cognitive tasks (N-back and emotional Stroop). Outcomes include oxygenated hemoglobin (HbO) concentration changes in dorsolateral prefrontal cortex (DLPFC), orbitofrontal cortex (OFC), and frontopolar area (FPA).
Measured: Baseline (pre-intervention), Week 8 (post-intervention)
Age
Participant age at the time of enrollment. Age is recorded as a continuous variable for descriptive purposes and will be used as a covariate in analyses.Unit of Measure: Years
Measured: Baseline
Height
Participant height measured in centimeters (cm) using a standardized stadiometer. Unit of Measure:Centimeters (cm)
Measured: Baseline
Weight
Participant weight measured in kilograms (kg) using a calibrated digital scale.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start7 Oct 2025
- Primary completion25 Jan 2026
- Study completion15 Feb 2026
Why it stopped: The first stage of recruitment has ended because all the college students have already taken their winter vacations.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ADHD - Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuhan Sports University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Liu, Beijing Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499427
- Sponsor's protocol ID
- Beijing Normal University
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study is a single-center trial and currently lacks the necessary infrastructure, funding, and standardized platform to support the curation and sharing of IPD. Data will be retained within the research team for the purpose of the primary analysis.
Publications
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.
PubMed 33541313Faheem 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.
PubMed 35878424
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07499427
- Acronym / sponsor ID
- Beijing Normal University
- Conditions
- ADHD - Attention Deficit Disorder With Hyperactivity, ADHD, ADHD - Combined Type, ADHD - Inattentive Type, ADHD Specifically With Executive Function Impairment
- Keywords
- ADHD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The first stage of recruitment has ended because all the college students have already taken their winter vacations.
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Wuhan Sports UniversityUniversity, hospital or other
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- 25 Jan 2026 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic Treadmill Training Group | Active comparator | Behavioral: Aerobic Treadmill TrainingParticipants 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. |
| Balance Training Group | Experimental | Behavioral: Progressive Balance TrainingParticipants 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. |
| Cognitive-Balance Dual-Task Training Group | Experimental | Behavioral: Cognitive-Balance Dual-Task TrainingParticipants 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic 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. | Behavioural | Aerobic Treadmill Training Group |
| Progressive 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. | Behavioural | Balance Training Group |
| Cognitive-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. | Behavioural | Cognitive-Balance Dual-Task Training Group |
Primary outcome
ADHD Core Symptom Severity
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 Interference Effect
Time frame: 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)
Inhibitory Control - Stroop Task Accuracy
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Dynamic Balance - Y-Balance Test Left Posterolateral Reach Distance
Time frame: 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.
Limb Asymmetry - Y-Balance Test Anterior Asymmetry Index
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 (%)
9 secondary outcomes
Anxiety Symptoms
Time frame: Baseline, Week 4 (mid-intervention), Week 8 (post-intervention)
Depressive Symptoms
Time frame: Baseline, Week 4 (mid-intervention), Week 8 (post-intervention)
Self-Esteem Level
Time frame: Baseline, Week 4 (mid-intervention), Week 8 (post-intervention)
Motor Coordination Difficulties
Time frame: Baseline, Week 4 (mid-intervention), Week 8 (post-intervention)
ADHD-Specific Quality of Life
Time frame: Baseline, Week 4 (mid-intervention), Week 8 (post-intervention)
Prefrontal Cortex Activation (Exploratory)
Time frame: Baseline (pre-intervention), Week 8 (post-intervention)
Age
Time frame: Baseline
Height
Time frame: Baseline
Weight
Time frame: Baseline
Results and safety
The study was stopped early (reason given: The first stage of recruitment has ended because all the college students have already taken their winter vacations.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Results publication: PubMed 33541313Adamou 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.
- Results publication: PubMed 35878424Faheem 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.
- Individual participant dataSharing planned: No. The study is a single-center trial and currently lacks the necessary infrastructure, funding, and standardized platform to support the curation and sharing of IPD. Data will be retained within the research team for the purpose of the primary analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Treadmill Training, Progressive Balance Training and Cognitive-Balance Dual-Task Training in people with ADHD - Attention Deficit Disorder With Hyperactivity and ADHD, run by Wuhan Sports University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The first stage of recruitment has ended because all the college students have already taken their winter vacations.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADHD Core Symptom Severity (time frame: Baseline, Week 4 (mid-intervention), Week 8 (post-intervention)). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07499427, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.