NCT04896671

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2020

Completed
7 months until next milestone

First Posted

Study publicly available on registry

May 21, 2021

Completed
Last Updated

May 25, 2021

Status Verified

May 1, 2021

Enrollment Period

1.5 years

First QC Date

October 15, 2020

Last Update Submit

May 20, 2021

Conditions

Keywords

physical exercisesocial functionbroad autism phenotypeexecutive function

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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).

    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.

    baseline and 6- week follow up

Secondary Outcomes (2)

  • Change from baseline aggression at 6 weeks

    baseline and 6- week follow up

  • Change from baseline empathy at 6 weeks

    baseline and 6- week follow up

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Behavioral: Physical exercise (running on a treadmill)

Waitlist control group

NO INTERVENTION

They receive no treatments.

Interventions

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 group

Eligibility Criteria

Age7 Years - 20 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsBased on born gender.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, 00000, Hong Kong

Location

MeSH Terms

Conditions

Motor ActivitySocial Adjustment

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorSocial Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Bess Yin-Hung Lam, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participants would not know there are two groups. Each participant would assume to participate in physical exercise at some point.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

October 15, 2020

First Posted

May 21, 2021

Study Start

April 1, 2019

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

May 25, 2021

Record last verified: 2021-05

Locations