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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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)
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.

Hong Kong1 site
  • The Hong Kong Polytechnic University

    Hong Kong, 00000

Other trials in Hong Kong

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.

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 groups in NCT04896671
Study groupRoleWhat they receive
Intervention groupExperimentalEach 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 groupNo interventionThey receive no treatments.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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)
  1. 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

  2. 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.

  1. First posted21 May 2021
  2. Study start1 Apr 2019
  3. Primary completion30 Sep 2020
  4. Study completion30 Sep 2020

Resources

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)
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

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.

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