NCT07381504

Aerobic Exercise for Sleep in Children With ASD

Acute Aerobic Exercise Intervention for Children With Autism Spectrum Disorder and Co-Occurring Sleep Disorder

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 3 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

Autism Spectrum Disorder (ASD) is a neurodevelopmental condition characterized by impairments in social interaction and communication. Children with ASD frequently experience co-occurring behavioral problems, among which sleep disturbances are highly prevalent, affecting approximately 40%-80% of children and adolescents with ASD. These sleep problems pose a substantial burden during childhood and adolescence. This study employs a two-phase design to examine the effects of an acute aerobic exercise intervention combined with a parent-mediated cognitive behavioral program on sleep problems in children with autism spectrum disorder (ASD). Phase 1 consists of cross-sectional assessments comparing sleep efficiency, physical fitness, and attentional performance among children with ASD with and without sleep problems and typically developing children. Phase 2 is a randomized controlled intervention trial involving children with ASD and comorbid sleep problems, in which participants are assigned to either an aerobic exercise plus cognitive behavioral intervention group or a control group receiving cognitive behavioral strategy materials only. The intervention lasts two weeks. Outcomes related to autistic symptoms, sleep efficiency, physical activity level, attentional performance , and adaptive behaviors are assessed before and after the intervention to evaluate intervention effects.

Detailed description

This study employs a two-phase design to investigate the effects of an acute aerobic exercise intervention combined with a parent-mediated cognitive behavioral program on sleep problems in children with Autism Spectrum Disorder (ASD). In Phase 1, cross-sectional assessments of sleep efficiency, physical fitness, and attentional performance will be conducted among children with ASD with and without sleep problems, as well as typically developing children. Phase 2 consists of a randomized intervention trial involving children with ASD and comorbid sleep problems. During Phase 2, Eligible participants will be randomly assigned to one of two groups: (1) an acute aerobic exercise combined with cognitive behavioral intervention group, or (2) a control group receiving cognitive behavioral strategies only. The intervention period will last two weeks. The acute aerobic exercise program will consist of moderate-to-vigorous-intensity intermittent aerobic exercise conducted twice per week, with each session lasting 30 minutes. Exercise intensity will be monitored and prescribed using standardized heart rate-based criteria to ensure participant safety and adherence to the target intensity range. Exercise sessions will be supervised by trained research staff. The cognitive behavioral component is parent-mediated. Parents in both groups will receive structured training in cognitive behavioral strategies targeting sleep-related behaviors, including sleep routines, environmental modifications, and behavioral reinforcement techniques. Parents will be instructed to implement these strategies consistently at home on a daily basis throughout the intervention period. Adherence to the intervention will be monitored through parental reports and regular communication with the research team. Outcome measures, including autistic symptoms, sleep efficiency, physical activity level, attentional performance and adaptive behaviors, will be assessed before and after the intervention to evaluate the effectiveness of the two intervention approaches.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Intervention 1: Acute Aerobic Exercise	Moderate-to-vigorous-intensity intermittent aerobic exercise conducted twice per week, 30 minutes per session, over a 2-week period. Exercise intensity is prescribed and monitored using heart rate-based criteria. All sessions are supervised by trained research staff.
BEHAVIORAL	Intervention 2: Parent-Mediated Cognitive Behavioral Training	Structured parent training in cognitive behavioral strategies targeting sleep-related behaviors, including sleep routines, environmental modifications, and behavioral reinforcement techniques. Parents are instructed to implement strategies daily at home throughout the intervention period.
BEHAVIORAL	Parent Self-Education Program	Children with ASD in the control group were provided with a Cognitive Behavioral Strategy Information, in which parents received written materials describing cognitive behavioral strategies relevant to supporting children's self-regulation and daily behaviors. Parents were encouraged to review the materials and apply the strategies at home as they deemed appropriate. No structured training sessions or supervised implementation were provided.

Timeline

• Start date: 2025-04-15
• Primary completion: 2026-07-31
• Completion: 2026-08-01
• First posted: 2026-02-02
• Last updated: 2026-02-02

Locations

1 site across 1 country: Taiwan