Examining the Association Between Physical Activity and Sleep Quality in Children With Autism Spectrum Disorder
1 other identifier
interventional
32
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2017
CompletedFirst Posted
Study publicly available on registry
November 21, 2017
CompletedStudy Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedDecember 6, 2017
November 1, 2017
1.4 years
November 9, 2017
December 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Sleep onset latency
Sleep onset latency (length of time taken to fall asleep, expressed in minutes, SOL) will be objectively measured by a GT3X accelerometer.
12-week
Sleep efficiency
Sleep efficiency (actual sleep time divided by time in bed, expressed as a percent, SE) will be objectively measured by a GT3X accelerometer.
12-week
Wake after sleep onset
Wake after sleep onset (length of time they were awake after sleep onset, expressed in minutes, WASO) will be objectively measured by a GT3X accelerometer.
12-week
Sleep duration
sleep duration (total sleep in hours and minutes, SD) will be objectively measured by a GT3X accelerometer.
12-week
Parental-assessed sleep quality
Participants' sleep patterns will be logged by their parents using Children's Sleep Habits Questionnaire (CSHQ), which is a validated 45-item parent-administered questionnaire to examine sleep patterns of young children. The total score ranged from 45 to 135.
12-week
Melatonin
All participants will be instructed to collect a 24-h urine sample. 6-sulfatoxymelatonin, a creatinine-adjusted morning urinary melatonin and representative of melatonin level, will be measured from the sample. The weekend has been chosen to allow the participants to stay at home for sample collection. All urine samples will be collected using 24-h urine bottles containing 0.1L of 0.5M hydrochloric acid as a preservative.
12-week
Study Arms (2)
Intervention group
EXPERIMENTALThe 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.
Control group
NO INTERVENTIONParticipants 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).
Interventions
The intervention is a 12-week jogging program consisting of 24 sessions (two sessions per week, 30 min per session).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 29654045DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2017
First Posted
November 21, 2017
Study Start
January 1, 2018
Primary Completion
June 1, 2019
Study Completion
June 1, 2019
Last Updated
December 6, 2017
Record last verified: 2017-11