Exercise Interventions for Children With Autism Spectrum Disorder

Exercise Interventions for Children With Autism Spectrum Disorder: Effects of Aerobic Exercise and Exergaming Intervention on Sleep, Motor, Executive Function and Brian Activation

The purpose of this clinical trial is to find out whether exergame and aerobic exercise can improve sleep, movement skills, thinking abilities, and brain activity in children with autism spectrum disorder (ASD).

This study aims to answer the following questions:

1. Can exergame and aerobic exercise improve sleep, movement skills, and thinking abilities in children with ASD?
2. Can exergame and aerobic exercise change brain activity in children with ASD?

Researchers will compare three different intervention programs:

1. Exergame combined with motor and behavioral intervention.
2. Aerobic exercise combined with motor and behavioral intervention.
3. Motor and behavioral intervention only. By comparing these three groups, researchers hope to determine whether adding exergames or aerobic exercise provides additional benefits for children with ASD.

Participants will:

1. Attend one intervention session each week for 8 weeks. Depending on the group they are assigned to, they will receive either exergames combined with motor and behavioral intervention, aerobic exercise combined with motor and behavioral intervention, or motor and behavioral intervention only.
2. Complete a home exercise program twice a week for 12 weeks.
3. Visit the laboratory three times for assessments: before the intervention begins, at the end of Week 8, and at the end of Week 12.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Procedure: Exergaming; Procedure: Conventional physical therapy; Behavioral: Behavioral Education; Procedure: Aerobic exercise

• Study Type: Interventional
• Enrollment (Estimated): 105
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yen-Tzu Wu, PT, Ph.D; Phone Number: 886-2-33668136; Email: yenwu@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Early Childhood Behavior Laboratory, School and Graduate Institute of Physical Therapy, National Taiwan University,
    • Contact: Yen-Tzu Wu, PT, Ph.D; Phone Number: 886-2-33668161; Email: yenwu@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 4-10 year (48-131 months).
• Have a clinical diagnosis of ASD.
• Able to follow two-step order.
• With sleep disturbances for more than 3 days per week in past 3 months reported by child's caregiver.
• The primary caregiver must be aged 20 years or older and capable of reading and writing in Chinese.

Exclusion Criteria:

• Having physical disabilities or congenital anomalies of extremities.
• Loss of vision or hearing function.
• The child has been diagnosed with genetic disorders (e.g., Down syndrome or Fragile X syndrome).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exergaming group; This experimental arm including exergame, motor intervention focusing on fundamental motor skills, and behavioral education on sleep disturbances.	Procedure: Exergaming; Exergaming is defined as a type of active video game (or non-immersive virtual reality) that requires players to engage in full-body movements, involving moderate-to-vigorous physical activity.; Procedure: Conventional physical therapy; Conventional physical therapy focusing on fundamental motor skills including locomotion and ball skills.; Behavioral: Behavioral Education; Behavioral education focusing on sleep hygiene and behavioral strategies (e.g., extinction, reinforcement, developing appropriate bedtime and consistent bedtime routine) to facilitate specific strategies for enhancing child's sleep qualities
Experimental: Interval based Aerobic Exercise group; This experimental arm including interval-based aerobic exercise, motor intervention focusing on fundamental motor skills, and behavioral education on sleep disturbances.	Procedure: Conventional physical therapy; Conventional physical therapy focusing on fundamental motor skills including locomotion and ball skills.; Behavioral: Behavioral Education; Behavioral education focusing on sleep hygiene and behavioral strategies (e.g., extinction, reinforcement, developing appropriate bedtime and consistent bedtime routine) to facilitate specific strategies for enhancing child's sleep qualities; Procedure: Aerobic exercise; Aerobic exercise (AE) will apply interval-based training model, which serve as a feasible form of AE with intermittent, high-intensity, short-duration characteristics, and alternates between periods of activity and rest.
Active Comparator: Control group; This experimental arm including motor intervention focusing on fundamental motor skills, and behavioral education on sleep disturbances.	Procedure: Conventional physical therapy; Conventional physical therapy focusing on fundamental motor skills including locomotion and ball skills.; Behavioral: Behavioral Education; Behavioral education focusing on sleep hygiene and behavioral strategies (e.g., extinction, reinforcement, developing appropriate bedtime and consistent bedtime routine) to facilitate specific strategies for enhancing child's sleep qualities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fundamental motor skills - Test of Gross Motor Development, Third Edition (TGMD-3)	The TGMD-3 is a standardized, norm-referenced test for testing gross motor skills development and quality for children aged 3 to 10 years 11 months. The scales consist of Locomotor and Ball skills subtests. The Locomotion subtest includes 6 items, and Ball skills subtest includes 7 items. Each item is scored with either 0 or 1 in 3 to 5 specific performance criteria. A score of 0 indicates that the performance criterion was not achieved, whereas a score of 1 indicates that the performance criterion was achieved. The score of Locomotion subtest ranges from 0 to 46, and the score of Ball skills subtest ranges from 0 to 54. Higher scores indicate better performance and greater maturity in the respective skills and overall fundamental motor skills. Raw scores for the subtests and total score can be converted to T-scores. Subtest T-scores have a mean of 10 (standard deviation = 3), and total score T-scores have a mean of 100 (standard deviation = 15).	Pre-test, on the 8th week, on the 12th week
Fundamental motor skill - Bruininks-Oseretsky Test of Motor Proficiency, Third Edition (BOT-3)	The BOT-3 is a standardized, norm-referenced test for testing motor proficiency for children aged 4 to 25 years 11 months. The scales consist of Fine motor (FM) and Gross motor (GM) composites. The FM composite induces 32 items from 4 subscales: Fine motor precision, Fine motor integration, Manual dexterity, and Upper-limb coordination. The GM composite induces 31 items from 4 subscales: Bilateral coordination, Balance, Strength, and Dynamic movement. Raw scores are converted to point scores using a comparison table, which are summed and converted to standard scores. Standard scores range from 40 to 160, with a mean of 100 (SD = 15). Higher scores indicate better performance.	Pre-test, on the 8th week, on the 12th week
Actigraph sleep assessment	Wrist-worn actigraphy will be used to measure sleep parameters including sleep efficiency (%), total time in bed (minutes), total sleep time (minutes), sleep latency (minutes), wake after sleep onset (minutes), number of awakenings (times), and average awakening duration (minutes). Sleep efficiency was the primary reported outcome and was calculated as (total sleep time / total time in bed) × 100. Total sleep time was calculated as total time in bed minus the sum of sleep latency and wake after sleep onset. The other actigraphy parameters were used to characterize sleep patterns and to derive the primary outcome.	Pre-test, on the 12th week
Executive functions - Behavior Rating Inventory of Executive Function, Preschool Version (BRIEF-P)	BRIEF-P is a set of questionnaires for the report from parents or teachers, designed to evaluate executive functions (EF) for child's ages 2 to 5 years 11 months.BRIEF-P consists of 63 items related to behavioral manifestations of EFs, rated on a 3-point scale indicating whether the behavior occurs never (1), sometimes (2), or often (3). The items are divided into five scales of EF (Inhibition, Shift, Emotional control, Working memory, and Planning/ Organization). Three indexes comprising scales are included: (1) Inhibitory Self-Control Index; (2) Flexibility Index; (3) Emergent Metacognition Index. The items of the five clinical scales also provide a Global Executive Composite. Higher scores indicate greater dysregulation in behaviors associated with EF, reflecting a worse outcome. For all BRIEF-P scales and indexes, T scores from 60 to 64 are considered mildly elevated, and T scores from 65 to 69 are considered potentially clinically elevated.	Pre-test, on the 8th week, on the 12th week
Executive functions - Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)	The BRIEF-2 is a set of questionnaires report from parents, designed to evaluate executive functions (EF) for child's ages 5 to 18 years. The BRIEF-2 consists of 63 items related to behavioral manifestations of EF, rated on a 3-point scale indicating whether the behavior occurs never (1), sometimes (2), or often (3). The items are divided into nine scales of EF (Inhibit, Self-Monitor, Shift, Emotional Control, Initiate, Working Memory, Plan/ Organize, Task-Monitor, and Organization of Materials). Three indexes comprising nine scales are included: (1) Behavior Regulation Index; (2) Emotion Regulation Index; (3) Cognitive Regulation Index. Higher scores indicate greater dysregulation in behaviors associated with EF, reflecting a worse outcome. For all BRIEF-2 scales and indexes, T scores from 60 to 64 are considered mildly elevated, and T scores from 65 to 69 are considered potentially clinically elevated. T scores at or above 70 are considered clinically elevated.	Pre-test, on the 8th week, on the 12th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adaptive behavior - Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)	The Vineland-3 is a parent-reported scale to assess a child's actual adaptive capabilities and behavioral performance within their daily environment. Which yields scores for 3 adaptive domains: Communication, Daily Living Skills, and Socialization and 9 subdomains. Furthermore, optional Motor Skills and Maladaptive Behavior domains are available for flexible use. Items are scored on a scale of 0 (Never), 1 (Sometimes), and 2 (Usually or Often). Total scores are expressed as raw scores and v-scores, with higher scores indicating better adaptive behavior.	Pre-test, on the 8th week, on the 12th week
Brain activation - Functional Near-Infrared Spectroscopy (fNIRS)	The brain activation of cerebral oxygenation will be monitored during two types dual motor-cognitive and dual motor tasks. A multichannel wearable fNIRS imaging system will be used to detect the hemodynamics of the bilateral prefrontal cortex (PFC), supplementary motor area (SMA), and premotor cortex (PMC). (PFC plays an important role in executive function; SMA is responsible for planning motor action and guiding self-initiated motor control; PMC is an area which integrates information about the target and the body-part to plan a forthcoming action.)	Pre-test, on the 12th week
Attention - Conners Kiddie Continuous Performance Test, 2nd Edition (K-CPT 2)	Attentional performance in children aged 4 to 7 years was assessed using the K-CPT 2, a computerized task designed to evaluate sustained attention and inhibitory control. During the test, children were required to respond to target stimuli and withhold responses to non-target stimuli over a continuous period of time. Key outcome measures included omission errors (failures to respond to target stimuli), commission errors (responses to non-target stimuli), reaction time, and reaction time variability, which together reflect attentional capacity, impulsivity, and response consistency. Each outcome measure is presented as a T-score ranging from 30 to 90, with a mean of 50 (standard deviation = 10). A T-score above 60 indicates a clinical elevation in attentional problems.	Pre-test, on the 8th week, on the 12th week
Attention - Conners Continuous Performance Test, Third Edition (CPT-3)	Attentional performance in children and adolescent aged above 8 years was assessed using the CPT-3, a computerized task designed to evaluate sustained attention and inhibitory control. During the test, children were required to respond to target stimuli and withhold responses to non-target stimuli over a continuous period of time. Key outcome measures included omission errors (failures to respond to target stimuli), commission errors (responses to non-target stimuli), reaction time, and reaction time variability, which together reflect attentional capacity, impulsivity, and response consistency. Each outcome measure is presented as a T-score ranging from 30 to 90, with a mean of 50 (standard deviation = 10). A T-score above 60 indicates a clinical elevation in attentional problems.	Pre-test, on the 8th week, on the 12th week
Autism-related symptoms - Social Responsiveness Scale, Second Edition (SRS-2)	The SRS-2 measures social ability of children from 2.5 to 18 years old, which is used primarily in individuals with ASD, others who have social impairments, and their family members. There are four forms of SRS-2 for a specific age group, each with 5 subscales including social awareness, social cognition, social communication, social motivation, as well as restricted interests and repetitive behavior. There are totally 65 items for each form, and each item is scored on a 4-point Likert-scale: 1 ("not true"), 2 ("sometimes true), 3 (often true), and 4 ("almost always true"). Total scores are expressed in raw and T-scores. This study will use the Preschool and School-Age Forms which are completed by parents. The SRS-2 has been reported to have good internal consistency, test-retest reliabilities, and inter-rater reliabilities.	Pre-test, on the 8th week, on the 12th week
Sleep problems - Children Sleep Health Questionnaire for Autism (CHSQ-Autism)	CHSQ-Autism is complete by the caregiver and consists of 23 items divided into 4 domains: sleep initiation duration, sleep anxiety/co-sleeping, night wakings/parasomnias, and daytime alertness. Each item is rated on a 3-point scale: 3 (Usually, 5~7 days/week), 2 (Sometimes, 2~4 days/week), and 1 (Rarely, 0~1 day/week). The total score of the CHSQ-autism is the sum of 23 items, ranging from 23 to 69. In the study, a cutoff score of above 41 was taken to indicate positive.	Pre-test, on the 8th week, on the 12th week
Sleep problems - Chinese version of OSA-18	OSA-18 is completed by the caregiver and consists of 18 items divided into 5 subscales: sleep disturbance, physical symptoms, emotional distress, daytime functioning, and caregiver concerns. Each item is rated on a 7-point scale. The total score of the OSA-18 is the sum of all 18 items, ranging from 18 (no effect on quality of life) to 126 (significant negative effect). A cutoff score of above 63 was taken to indicate positive status in Taiwanese preschoolers aged 3-5 years, given its greater accuracy in identifying abnormal values.	Pre-test, on the 8th week, on the 12th week

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): July 30, 2028

Study Registration Dates

• First Submitted: August 13, 2026
• First Submitted That Met QC Criteria: August 25, 2026
• First Posted (Actual): August 27, 2026

Study Record Updates

• Last Update Posted (Actual): August 27, 2026
• Last Update Submitted That Met QC Criteria: August 25, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Aerobic exercise; Sleep; fNIRS; Brain activation; Executive function; Exergaming; Motor skills
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Exergaming
• Other Study ID Numbers: 202412056RINC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No