Examining the Association Between Physical Activity and Sleep Quality in Children With Autism Spectrum Disorder

NCT ID: NCT03348982

Last Updated: 2017-12-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-31
• Study Completion Date: 2019-06-30

Brief Summary

This study aims to investigate whether physical activity intervention would be effective to improve sleep quality in children with ASD, and investigate how physical activity impacts on sleep in children with ASD through melatonin-mediated mechanism model. A parallel-group randomized controlled trial comparing a 12-week jogging intervention and a control group receiving standard care in 32 children with ASD will be conducted. This study will monitor the changes of four sleep parameters (sleep onset latency; sleep efficiency, wake after sleep onset and sleep duration) through objective actigraphic assessment and parental sleep logs.

Detailed Description

Sleep disturbance is commonly found in children with autism spectrum disorder (ASD) and is often accompanied with family distress. Disturbed sleep may exacerbate the core symptoms of ASD including stereotypic behaviors, social interactions, and health problems. Therefore, it is important to develop effective intervention strategies to ameliorate the sleep disturbance in children with ASD. Traditionally, behavioral interventions and supplemental melatonin medication are used to improve their sleep quality. However, poor sustainability of behavioral intervention effects and use of other medications (e.g. antidepressants and stimulants) that metabolize melatonin may degrade the effectiveness of these interventions. Alternatively, previous research supported physical activity intervention as an effective treatment on sleep disturbance for typically developing children who suffered from sleep disturbance. It is therefore natural to extend the study to examine whether such intervention is also effective in children with ASD. This study aims to investigate whether physical activity intervention would be effective to improve sleep quality in children with ASD. Moreover, how physical activity impacts on sleep in children with ASD through melatonin-mediated mechanism model will also be investigated. According to this mechanism model, it is suggested that physical activity could affect circadian rhythm through altering melatonin level. Melatonin is generally lower in ASD children than in their typically developing counterparts and supplemental melatonin medication is often used to treat the sleep disturbance in this population. This study is a parallel-group randomized controlled trial comparing a 12-week jogging intervention and a control group receiving standard care in 32 children with ASD. The changes of four sleep parameters (sleep onset latency; sleep efficiency, wake after sleep onset and sleep duration) through objective actigraphic assessment and parental sleep logs will be monitored. To measure melatonin level, all participants will be instructed to collect a 24-h urinary sample. 6-sulfatoxymelatonin, a creatinine-adjusted morning urinary melatonin and representative for melatonin level, will be measured from the collected urine sample. All the assessments will be carried out before the intervention (T1), immediately after the 12 weeks of physical activity intervention or regular treatment (T2), and 12 weeks after post-intervention (T3) for examination of sustained intervention effect. The findings of this proposed study can provide information on the mechanism pathway that physical activity impacts on sleep in children with ASD, which will contribute to the design of an effective intervention to improve sleep quality for children with ASD.

Conditions

Physical Activity; Sleep Apnea; Autism Spectrum Disorder

Keywords

Physical activity; Sleep; Children; Autism Spectrum Disorder; Melatonin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

The intervention is a 12-week jogging program consisting of 24 sessions (two sessions per week, 30 min per session) in a hall/gymnasium of each participating school.Each intervention session will be conducted in the morning by a trained research assistant assisted by student helpers. Each intervention session will be conducted in an identical format, comprising three activities: warm-up (5 min), jogging (20 min), and cool-down (5 min). In the jogging activity, participants will be asked to jog side-by-side with the research staff around an activity circuit (57m x 50m) marked with 4 red cones.

Group Type: EXPERIMENTAL

Jogging program

Intervention Type: BEHAVIORAL

The intervention is a 12-week jogging program consisting of 24 sessions (two sessions per week, 30 min per session).

Control group

Participants in the control group will receive no physical intervention and will be required to follow their daily routine without participating in any additional physical activity/exercise program throughout the whole study period (T1-T3).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Jogging program

The intervention is a 12-week jogging program consisting of 24 sessions (two sessions per week, 30 min per session).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• pre-puberty or early puberty as indicated by Tanner stage I or II ;
• ASD diagnosis from a physician based on Diagnostic and Statistical Manual of Mental Disorders, 5th edition, (DSM-V)[42]
• non-verbal IQ over 40
• the ability to follow instructions;
• physically able to participate in the intervention
• no additional regular participation in physical exercise other than school physical education classes for at least 6 months prior to the study
• no concurrent medication for at least 6 months before the study or any prior melatonin treatment;
• have sleep difficulties, including sleep onset insomnia and frequent and prolonged nightwaking and/or early morning awakenings reported by parents

Exclusion Criteria

• with one or co-morbid psychiatric disorders as established by a structured interview based on DSM-V
• with other medical conditions that limit their physical activity capacities (e.g., asthma, seizure, cardiac disease);
• with a complex neurologic disorder (e.g., epilepsy, phenylketonuria, fragile X syndrome, tuberous sclerosis)

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Andy CY Tse, PhD

Role: CONTACT

Phone: 29488074

Email: andytcy@eduhk.hk

Paul H Lee, PhD

Role: CONTACT

Phone: 34008275

Email: paul.h.lee@polyu.edu.hk

References

Tse ACY, Lee PH, Zhang J, Lai EWH. Study protocol for a randomised controlled trial examining the association between physical activity and sleep quality in children with autism spectrum disorder based on the melatonin-mediated mechanism model. BMJ Open. 2018 Apr 13;8(4):e020944. doi: 10.1136/bmjopen-2017-020944.

Reference Type: DERIVED

PMID: 29654045 (View on PubMed)

Other Identifiers

28602517

Identifier Type: -

Identifier Source: org_study_id