Effects of Systematic Exercise Training on Core Symptoms, Executive Function and Brain Function in Children With ASD

Condition(s) studied

Investigational drug(s) / intervention(s)

The Child-Parent- Trainer exercise program: The Child-Parent-Trainer exercise program is a 12-week exercise training program, which is based on the sensory and cognitive needs of children with ASD, multiple game forms are integrated to form a multi-sensory intervention model. The exercise program is developed according to the types of exercise recommended in the Exercise Guidelines for Preschool Children of China, including the development of basic motor skills, such as physical movement, posture control, object control; development of important physical qualities, such as agility, balance, coordination. The training program for different age group consists of physical movement items, object control items and limb coordination items. The exercise intensity is moderate.

The regular physical training: The regular physical training courses will last for 12 weeks. It is training in motor skills and fine motor skills. The items include passing the ball, lifting small dumbbells, running, handicrafts, etc. There is no requirement for the intensity of the exercise.

Study summary

Studies have shown that children with ASD simultaneously have deficits in overall executive function and impairments in basic motor skills, which have a negative impact on cognitive and social all-round development. In recent years, intervention measures for the motor skills of children with ASD have gradually developed. However, based on the existing literature, there is still a lack of recommendations for sports training at present. The sustained effect of exercise intervention training on the core symptoms of ASD remains unclear. In terms of executive function, there are relatively few studies on the executive function of preschool children. The impact of motor training on working memory in school-aged children is still inconsistent. Furthermore, the connection characteristics of different brain regions in children with ASD after physical training remain unclear. This study will include 70 children with ASD aged 3 to 9 years for a multicenter randomized controlled trial (RCT). These children will be randomly assigned to the intervention group (Child-Parent-Trainer program) and the control group (regular physical education program) for 12 weeks, 5 days/week, 60 minutes/day training. Children's core symptoms, executive function, child/family quality of life, and functional near-infrared spectroscopy (fNIRS) were assessed at baseline (training weeks 0) and endpoints (training weeks 13 and 17), respectively. To verify the improvement effect of this exercise program on the autism severity, core symptoms and executive functions of children with ASD, as well as its impact on family quality of life. Furthermore, through fNIRS for monitoring changes in brain function, the potential neural physiological mechanisms will be explored.

Eligibility

Primary outcome measure(s)

• The changes in degree of ASD disorder by Autism Diagnostic Observation Schedule-2 — Training weeks 0, 13, and 17.
  The changes in degree of ASD disorder by Autism Diagnostic Observation Schedule-2 Description: The Autism Diagnostic Observation Schedule-2 (ADOS-2) is adopted to assess the changes in the degree of ASD disorder. The Autism Diagnostic Observation Schedule-2 (ADOS-2) is a standardized observational assessment. The assessment includes abilities in four areas: social interaction, stereotypical behavior, verbal communication, emotion, and abnormal behavior. Children in the our study were administered a module 1 for children with little or no phrase speech or Module 2, for children who use phrase speech but are not yet fluent. Standardized ADOS scores in the domains of social affect (SA) and restricted repetitive behaviors (RRB) were calculated as indicators of ASD severity.
• The changes in degree of ASD disorder by Childhood Autism Rating Scale (CARS) — Training weeks 0, 13, and 17.
  The Childhood Autism Rating Scale (CARS) are adopted to assess the changes in the degree of ASD disorder. The Childhood Autism Rating Scale (CARS) serves as an assessment indicator for the improvement of ASD symptoms. The scale consists of 15 items including relationship with people, imitation, emotional response, etc. The evaluation criteria for therapeutic effect are as follows: a CARS score reduction of less than or equal to 10 is considered effective, a CARS score reduction of 5 to 9 is considered effective, and a score reduction of less than 5 is considered ineffective.
• The changes of executive functions — Training weeks 0, 13, and 17.
  The preschool BRIEF is consisted of 63 entries and divided into 5 factors and 3 dimensions. The 5 factors are inhibition, conversion, affective control, working memory, and organizational planning. The 3 dimensions are the inhibitory self-regulation index (including inhibition and affective control), cognitive flexibility index (including conversion and affective control) and metacognitive index (including working memory and organizational planning). School-age children BRIEF, consisting of 86 entries, is divided into 2 dimensions: behavior management index (including 3 factors of inhibition, conversion and emotional control) and metacognitive function index (including 5 factors of task initiation, working memory, planning, organization and monitoring). The higher the score, the more impaired the executive function. We examine the score of BRIEF to reflect changes in executive function before and after training.
• The changes of brain function detection indicators — Training weeks 0, 13, and 17.
  We monitor cerebral hemodynamic changes through the fNIRS device. The Go/No-Go paradigm task was performed on children over 4 years old. This paradigm consists of two main parts, GO and GO /No-Go. During the GO task, participants are shown pictures of two animals (a giraffe and a lion) and instructed to quickly press the space bar when they see an animal picture. During the GO /No-Go task, pictures of two animals (a tiger and an elephant) are shown at random, and children are asked to quickly press the space bar when they see an elephant. To record correct rate and response time for analysis. All the subjects will undergo resting-state functional connectivity tests. We will compare the differences in fNIRS features before and after training.

Trial sites (1)

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