Clinical trial NCT04896671: Physical Exercise Training to Enhance Executive and Social Functions
Official title: Neural Mechanism of Physical Exercise in Enhancing Executive and Social Functions in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Broad Autism Phenotype
Keywords: physical exercise
social function
broad autism phenotype
executive function
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: The Hong Kong Polytechnic University
name: Griffith University
First posted: 2021-05-21
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 30 participants with BAP were randomly assigned to either groups: 1) intervention group (12 treadmill running sessions, two sessions per week and each session 30 minutes) and 2) control group: waitlist control group.
Primary purpose: TREATMENT

Brief summary: Background and study aims: Executive functions (EF) and social functions are important for self-regulation, problem solving, and attaining future goals yet they are impaired in Autism Spectrum Disorder (ASD). Physical exercise (PE) is found to enhance these central cognitive and social impairments in ASD. While limited research has begun to target these impairments in clinical samples, the presence of sub-clinical traits of ASD (refer to as broad autism phenotype (BAP)) in the general population is more common than the 1% prevalence of ASD. Therefore, it is crucial to study these impairments in the sub-clinical individuals. This study aims to investigate the effectiveness of PE in enhancing the EF and social functions in the BAP adolescents. Method: Participants will be recruited from the local community and they should be between the age of 7-20 years without any psychiatric disorders. Expected results: PE is predicted to be effective in reducing the EF and social impairments in these adolescents. Implications: These findings can inform us with the knowledge to design a community-based PE training targeting EF problems in these adolescents with BAP in the local context. Ultimately, this training can be incorporated to the curriculum of the primary and secondary schools targeting BAP and associated impairments in adolescents.

Detailed description: Executive functions (EF) refer to goal-directed cognitive processes consisting of three major components including cognitive flexibility (mental flexibility), inhibition (inhibitory control) and working memory. These components interact with each other and play a crucial role in a range of life outcomes including mental and physical health, school and job success and marital harmony. In addition, higher EF is associated with better problem solving, reasoning and planning skills as well as social functions.

Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterised by social communication and interaction impairments, as well as restricted and repetitive patterns of behavior. Individuals with ASD have EF impairments which are linked to the restricted and repetitive behaviors that characterise this condition. The prevalence of ASD is increasing with as many as 1 in 68 individuals, which further augments the burden to the ASD individuals, their families and society. Hence, it is essential to investigate the underlying mechanism of ASD and design a cost-effective training that can be widely adopted in the community to reduce impairments arising from ASD symptoms.

Importantly, ASD traits occur on a continuum, and increasingly there is recognition of a broader autism phenotype (BAP) in those that show sub-clinical symptoms. Similarly, these individuals also show impairments in executive function and social functions, making this group an important target for the development and implementation of interventions. As such, we can deliver appropriate training at an earlier stage to prevent associated impairments in those with ASD traits. Therefore, instead of ASD, the present study examines the individuals with BAP.

Given EF impairments along with social function deficits are found in the sub-clinical individuals with BAP, is the training pertaining to ASD applicable to these individuals? In prior literature, physical exercise (PE) has been proved to enhance EF and social functions. For instance, regular PE can enhance cerebral blood flow and increase the formation of new blood vessels in a number of brain regions that are involved in EF and social functions. More specifically, PE is shown to enhance the performance of EF in healthy children and pre-adolescents and those with ASD. For example, it was found that PE including jogging significantly decreased the repetitive and off-task behaviors and the level of aggression in individuals with ASD. Nevertheless, although PE is shown to be beneficial to reduce the symptoms and EF as well as social impairments in ASD, whether it produces the same positive outcomes in the non-clinical individuals. To address the research questions listed above, this proposed study aims to investigate whether PE training enhances the EF and social functions in the adolescents with BAP.

Although the benefits of physical exercise have been studied in the ASD, BAP is under studied in prior literature. This proposed study will extend from the current literature to investigate the non-clinical group who have autistic traits with a longitudinal and randomized controlled trial design (RCT). The findings of this proposed study have multiple levels of significance and implications. For instance, if the hypotheses are supported, the PE training which is more cost-effective than psychotherapy in treating EF and social functioning deficits and associated impairments can be promoted to school settings. Ultimately, it can be incorporated to the curriculum of the primary and secondary schools to reduce BAP and associated impairments in the adolescents. Secondly, by examining those with sub- clinical symptoms, this research will contribute to early trainings approaches for the condition. Lastly, this proposed study can also help promote physical activities among adolescents which can further decrease mental and health issues in the local context.

Eligibility criteria: Inclusion Criteria:

* Age ranges from 7 to 20
* Studying at one of the local schools
* Have never been diagnosed with ASD or any other disorder listed in the Fifth Edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
* Are not currently under any psychiatric medications or therapies

Exclusion Criteria:

* Have been diagnosed with ASD or any other disorder listed in the Fifth Edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
* Are currently under any psychiatric medications or therapies

Primary outcomes:
measure: Demographics
timeFrame: Before intervention (baseline)
measure: Change from baseline autistic traits at 6 weeks
timeFrame: baseline and 6- week follow up
measure: Change from baseline executive functions at 6 weeks
timeFrame: baseline and 6- week follow up
measure: Change from baseline psychological resilience at 6 weeks
timeFrame: baseline and 6- week follow up
measure: Change from baseline schizotypal personality traits at 6 weeks
timeFrame: baseline and 6- week follow up
Secondary outcomes:
measure: Change from baseline aggression at 6 weeks
timeFrame: baseline and 6- week follow up
measure: Change from baseline empathy at 6 weeks
timeFrame: baseline and 6- week follow up
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The University of Hong Kong
name: Bess Yin-Hung Lam, PhD
role: PRINCIPAL_INVESTIGATOR
References: