Broad Autism PhenotypeNCT04896671
Physical Exercise Training to Enhance Executive and Social Functions
A study testing Physical exercise (running on a treadmill) in people with Broad Autism Phenotype, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Broad Autism Phenotype
- What is being tested?
- Physical exercise (running on a treadmill)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Apr 2019to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neural Mechanism of Physical Exercise in Enhancing Executive and Social Functions in Adolescents
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.
Read the 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
- Being tested
- Physical exercise (running on a treadmill)
- Keywords
- physical exercise, social function, broad autism phenotype, executive function
- Medical subject headings
- Motor Activity, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exercise (running on a treadmill)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Each participant joins a total of 12 treadmill running sessions, two sessions per week and each session for 30 minutes. Receives: Behavioral: Physical exercise (running on a treadmill) |
| Waitlist control group | No intervention | They receive no treatments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographics
A simple demographic questionnaire will be used to gather participants personal information, including age, gender, current medication or therapy, and medical history of the participant and his/her family members.
Measured: Before intervention (baseline)
Change from baseline autistic traits at 6 weeks
The Autism-Spectrum Quotient-Adolescent Version (AQ-Adolescent; Baron-Cohen et al., 2006) and related self-report scales will be used to measure ASD traits. The AQ- adolescent is a self-report questionnaire comprising of 50 items assessing five areas, namely social, attention switching, attention to detail, communication and imagination.
Measured: baseline and 6- week follow up
Change from baseline executive functions at 6 weeks
EF and social functions will be measured using the Cambridge Neuropsychological Test Automated Battery (CANTAB). The CANTAB is a computerized test battery targeting multiple neuropsychological functions. This battery includes Reaction Time, Paired Associates Learning, Spatial Working Memory, One Touch Stockings of Cambridge, Multitasking Test, and Emotion Recognition Task.
Measured: baseline and 6- week follow up
Change from baseline psychological resilience at 6 weeks
Participant's psychological resilience will be measured by 10-item Connor-Davidson Resilience Scale (CD-RISC).
Measured: baseline and 6- week follow up
Change from baseline schizotypal personality traits at 6 weeks
Schizotypal Personality Questionnaire will be used to measure schizotypal personality traits.
Measured: baseline and 6- week follow up
Secondary outcomes (2)
Change from baseline aggression at 6 weeks
Reactive and Proactive Aggression Questionnaire will be used to measure aggression in the participants.
Measured: baseline and 6- week follow up
Change from baseline empathy at 6 weeks
Cognitive, Affective and Somatic Empathy Scale (CASES) will be used to measure empathy.
Measured: baseline and 6- week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start1 Apr 2019
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Broad Autism PhenotypeStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Polytechnic University, Griffith University
- Responsible party
- Principal investigator, LAM, Yin Hung, The University of Hong Kong
- Investigators
- Bess Yin-Hung Lam, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896671
- Sponsor's protocol ID
- HSEARS20190311003
- Status last verified
- May 2021
- First submitted
- 15 Oct 2020
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanism of Physical Exercise in Enhancing Executive and Social Functions in Adolescents
- ClinicalTrials.gov ID
- NCT04896671
- Acronym / sponsor ID
- HSEARS20190311003
- Conditions
- Broad Autism Phenotype
- Keywords
- physical exercise, social function, broad autism phenotype, executive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- The Hong Kong Polytechnic University, Griffith University
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 21 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Physical exercise (running on a treadmill)Each participant joins a total of 12 treadmill running sessions, two sessions per week and each session for 30 minutes. |
| Waitlist control group | No intervention | –They receive no treatments. |
Who may qualify
- Ages
- 7 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention group |
Primary outcome
Demographics
Time frame: Before intervention (baseline)
A simple demographic questionnaire will be used to gather participants personal information, including age, gender, current medication or therapy, and medical history of the participant and his/her family members.
Change from baseline autistic traits at 6 weeks
Time frame: baseline and 6- week follow up
The Autism-Spectrum Quotient-Adolescent Version (AQ-Adolescent; Baron-Cohen et al., 2006) and related self-report scales will be used to measure ASD traits. The AQ- adolescent is a self-report questionnaire comprising of 50 items assessing five areas, namely social, attention switching, attention to detail, communication and imagination.
Change from baseline executive functions at 6 weeks
Time frame: baseline and 6- week follow up
EF and social functions will be measured using the Cambridge Neuropsychological Test Automated Battery (CANTAB). The CANTAB is a computerized test battery targeting multiple neuropsychological functions. This battery includes Reaction Time, Paired Associates Learning, Spatial Working Memory, One Touch Stockings of Cambridge, Multitasking Test, and Emotion Recognition Task.
Change from baseline psychological resilience at 6 weeks
Time frame: baseline and 6- week follow up
Participant's psychological resilience will be measured by 10-item Connor-Davidson Resilience Scale (CD-RISC).
Change from baseline schizotypal personality traits at 6 weeks
Time frame: baseline and 6- week follow up
Schizotypal Personality Questionnaire will be used to measure schizotypal personality traits.
2 secondary outcomes
Change from baseline aggression at 6 weeks
Time frame: baseline and 6- week follow up
Change from baseline empathy at 6 weeks
Time frame: baseline and 6- week follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bess Yin-Hung Lam, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise (running on a treadmill) in people with Broad Autism Phenotype, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographics (time frame: Before intervention (baseline)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021.