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.
Study Goal
The researchers aimed to determine whether a 12-week physical activity intervention could improve sleep quality or melatonin levels in children with autism spectrum disorders (ASD).
Results Summary
The abstract describes a study protocol but does not report results regarding melatonin's effects, as the study was still ongoing at the time of the abstract's submission.
Population
Children with autism spectrum disorders (ASD).
Effective Dosage
Not specified.
Duration
12 weeks.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
behavioural interventions | no change | sleep quality | children with autism spectrum disorders (ASD) | - | poor sustainability of effects | #1 |
supplemental melatonin medication | decrease | sleep quality | children with autism spectrum disorders (ASD) | - | degraded effectiveness | #2 |
physical activity | decrease | sleep disturbance | typically developing children | - | may provide an effective intervention | #3 |
jogging intervention | neutral | sleep quality | children with ASD | - | elicits changes | #4 |
jogging intervention | neutral | melatonin levels | children with ASD | - | elicits changes | #5 |
INTRODUCTION: Sleep disturbance is commonly observed in children with autism spectrum disorders (ASD). Disturbed sleep may exacerbate the core symptoms of ASD. Behavioural interventions and supplemental melatonin medication are traditionally used to improve sleep quality, but poor sustainability of behavioural intervention effects and use of other medications that metabolise melatonin may degrade the effectiveness of these interventions. However, several studies have suggested that physical activity may provide an effective intervention for treating sleep disturbance in typically developing children. Thus, we designed a study to examine whether such an intervention is also effective in children with ASD. We present a protocol (4 December 2017) for a jogging intervention with a parallel and two-group randomised controlled trial design using objective actigraphic assessment and 6-sulfatoxymelatonin measurement to determine whether a 12-week physical activity intervention elicits changes in sleep quality or melatonin levels. METHODS AND ANALYSIS: All eligible participants will be randomly allocated to either a jogging intervention group or a control group receiving standard care. Changes in sleep quality will be monitored through actigraphic assessment and parental sleep logs. All participants will also be instructed to collect a 24-hour urine sample. 6-sulfatoxymelatonin, a creatinine-adjusted morning urinary melatonin representative of the participant's melatonin levels, will be measured from the sample. All assessments will be carried out before the intervention (T1), immediately after the 12-week intervention or regular treatment (T2), 6 weeks after the intervention (T3) and 12 weeks after the intervention (T4) to examine the sustainability of the intervention effects. The first enrolment began in February 2018. ETHICS AND DISSEMINATION: Ethical approval was obtained through the Human Research Ethics Committee, Education University of Hong Kong. The results of this trial will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03348982.