Physical Exercise Training to Enhance Executive and Social Functions

NCT ID: NCT04896671

Last Updated: 2021-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2020-09-30

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.

Conditions

Broad Autism Phenotype

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention group

Each participant joins a total of 12 treadmill running sessions, two sessions per week and each session for 30 minutes.

Group Type: EXPERIMENTAL

Physical exercise (running on a treadmill)

Intervention Type: BEHAVIORAL

Participants in the intervention group join a total of 12 treadmill running sessions, two sessions per week and each session for 30 minutes. In each session, every participant will be trained to run for 30 minutes on a treadmill. According to Exercise and Sports Science Australia (ESSA) exercise intensity guidelines, the intensity of running is suggested to be moderate and vigorous (alternating between the two) in this study.

Waitlist control group

They receive no treatments.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Physical exercise (running on a treadmill)

Participants in the intervention group join a total of 12 treadmill running sessions, two sessions per week and each session for 30 minutes. In each session, every participant will be trained to run for 30 minutes on a treadmill. According to Exercise and Sports Science Australia (ESSA) exercise intensity guidelines, the intensity of running is suggested to be moderate and vigorous (alternating between the two) in this study.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: collaborator

Griffith University

OTHER

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

LAM, Yin Hung

Research Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bess Yin-Hung Lam, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Countries

Hong Kong

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

HSEARS20190311003

Identifier Type: -

Identifier Source: org_study_id