NCT05503459

Brief Summary

Physical exercise is widely reported to be beneficial to executive functions (EFs) in children with autism spectrum disorder (ASD). However, the impact of physical exercise on self-regulation (SR) in this population remains unknown. Moreover, very few studies have been done to examine the mechanism(s) that underlie the exercise-EF and exercise-SR relationships. The purposes of the present study were to test whether two types of physical exercise (cognitively engaging vs. non-cognitively engaging) benefited SR, and if the social, emotional and physical needs of an individual mediated the exercise-EF and exercise-SR relationships. Children diagnosed with ASD were randomly assigned into one of three groups: learning to ride a bicycle (n = 23), stationary cycling (n = 19) or an active control with walking (n = 22). Two EFs (flexibility and inhibition), SR and the mediating roles of perceived social support, enjoyment, stress, physical self-efficacy and perceived physical fitness were assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

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

March 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2022

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 16, 2022

Completed
Last Updated

August 23, 2022

Status Verified

August 1, 2022

Enrollment Period

1.2 years

First QC Date

August 11, 2022

Last Update Submit

August 19, 2022

Conditions

Keywords

Cognitive functionSelf-regulationExecutive FunctionPhysical exerciseChildrenAutism

Outcome Measures

Primary Outcomes (7)

  • Change of cognitive flexibility

    The change of cognitive flexibility was measured by change of interference scores in the Stroop Color and Word Test between pre- and post-intervention. In the test, the participants were required to read three different tables as fast as they could. The three different tables were classified into two conditions: congruent and incongruent conditions. And the interference score was calculated based on a recognized formula ((Maximum:120; Minimum: 0). Lower interference scores indicate better cognitive flexibility.

    The outcome measure was conducted day 1 before intervention and within 30 minutes after intervention.

  • Change of inhibition

    The change of inhibition was measured by the change of false alarm scores in the Go/No-go test between pre- and post-intervention. In this assessment, participants were asked to press a left or right key as quickly as possible when the corresponding arrow appeared on the center of a computer screen (Go response), and not to press any key whenever the up arrow appeared on the screen (No-go response). The participants completed 300 trials: 220 trials requiring a Go response (110 left and 110 right) and 80 trials (26.7%) requiring a No-go response (not pressing any key). The stimuli were randomly presented, one at a time, for 500 ms followed by 1000 ms of blank interval using E-Prime 3.0 software . After blocks of 60 trials, children were offered a break of 2 minutes. A Go response in a No-go trial was coded as a false alarm. FA errors are considered an indicator of inhibition (maximum 60; minimum: 0), and the lower the error, the better the inhibition.

    The outcome measure was assessed day 1 before intervention and within 30 minutes after intervention.

  • Perceived social support

    The perceived social support of the participant was assessed with a self-reported scale referenced on the Athlete Received Support Questionnaire. Considering the comprehension difficulties of the participants, six items were chosen by the focus group (consisting of the authors, caregivers and teachers of the participants). Each participant was asked to rate their perceived social support with verbal prompting from their partnered student helpers. The total score was computed from the scale (Maximum:6; Minimum: 0). The higher the score, the better the perceived social support.

    The outcome measure was conducted immediately after 5th intervention (day 5).

  • Enjoyment

    Participants were assisted in rating their enjoyment of the interventions and walking (active control) using the Physical Activity Enjoyment Scale. The scale was rated on 5-point Likert scale). The total score was computed from the scale (Maximum: 20; Minimum: 0). The higher the total score, the better the enjoyment.

    The outcome measure was conducted immediately after 5th intervention (day 5).

  • Stress level

    Referenced on the Feeling Scale, a stress scale was designed by the focus group in the present study. Similar to the Feeling Scale, participants were asked to indicate their stress level from "very relaxed" (+5) to "very stressed" (-5) during the middle of the intervention. The higher the score, the lower the stress level.

    The outcome measure was conducted immediately after 5th intervention (day 5).

  • Physical self-efficacy

    Participants were assisted in rating their self-efficacy in the interventions and walking (active control) using the Physical Self-efficacy Scale. This scale is rated on 4-point Likert scale. The total score was computed from the scale (Maximum:16; Minimum: 0). The higher the total score, the better an individual's physical self-efficacy

    The outcome measure was conducted immediately after 5th intervention (day 5).

  • Perceived physical fitness

    Participants were asked 'How could you evaluate our own physical fitness when comparing with others?' and told to answer using a five-point scale (Maximum: 5; Minimum:0). The higher the rating, the better the perceived physical fitness.

    The outcome measure was conducted immediately after 5th intervention (day 5).

Study Arms (3)

Bicycle learning

EXPERIMENTAL

The protocol for this intervention group was a 2-week bicycle training program consisting of 10 sessions (five sessions per week, 60 mins per session) in a hall/gymnasium of each participating school and the Education University of Hong Kong. Each intervention session was conducted by a professional cycling instructor assisted by student helpers. The staff-to-participant ratio was 1:1.

Other: Bicycle learning

Stationary cycling group

EXPERIMENTAL

Participants were asked to ride on a stationary bicycle in the same format as that in the learning to bicycle group.

Other: Stationary cycling

Active control group

NO INTERVENTION

Participants were asked to walk with their major caregivers for 20 minutes every day during the study period. After the study, they were taught how to ride a bicycle to recognize their contribution as controls.

Interventions

The 10 intervention sessions were conducted in an identical format, comprising three activities: warm-up (10 min), bicycle learning (40 min), and cool-down (10 min). In the bicycle training activity, participants were asked to ride on a training bicycle with training wheels to gain better control of the bike in a gradual way. Participants then progressed from the training bicycle to a two-wheel bicycle. To keep participants on the learning curve, they were asked to ride through an obstacle course that was progressively more difficult to negotiate. The obstacles were designed by a focus group, which consisted of four physical education teachers from participating schools and one experienced cycling coach with more than five years of coaching experience.

Bicycle learning

The 10 intervention sessions were conducted in an identical format, comprising three activities: warm-up (10 min), stationary cycling (40 min), and cool-down (10 min). For stationary cycling activity, they were also asked every 10 mins during exercise to indicate their ratings of perceived exertion (target range: 3-5). Participants were positively reinforced verbally with compliments for their efforts in the training program and their daily improvements were visualized through graphs kept in the child's home.

Stationary cycling group

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • age 8 - 12 years
  • mild to moderate ASD (i.e., level 1-2 support classification) diagnosis from physicians or psychologists based on the Diagnostic and Statistical Manual of Mental Disorders, 5th edition, (DSM-5) and Autism Diagnostic Observation Schedule, 2nd Edition (ADOS-2)
  • non-verbal IQ over 50 using a brief version of the Wechsler Intelligence Scale for Children (Chinese revised) \[C-WISC\]
  • able to follow instructions with the assistance of research staff
  • able to perform the requested physical intervention, executive function measures and mediator measures with the assistance of the research staff
  • no additional regular participation in physical exercise other than school physical education classes for at least one month prior to the study
  • novice at riding a two-wheel bicycle (i.e., cannot ride the bicycle alone for more than 10 consecutive seconds).

You may not qualify if:

  • other medical conditions that limited physical exercise capacities (e.g., asthma, seizure, cardiac disease)
  • a complex neurologic disorder (e.g., epilepsy, phenylketonuria, fragile X syndrome, tuberous sclerosis)
  • suffering from obesity (i.e., \> 95 percentile of age-gender specific BMI cutoff, such that it would be difficult for research staff to catch them if they began to fall when riding
  • self-reported color blindness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EdUHK

Hong Kong, China, 0000, Hong Kong

Location

MeSH Terms

Conditions

Cognitive DysfunctionAutistic DisorderSelf-ControlMotor Activity

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersAutism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersSocial BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The staff responsible for the cognitive assessments and data analyses were not aware of the participants' group assignments.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and Acting Head of Department

Study Record Dates

First Submitted

August 11, 2022

First Posted

August 16, 2022

Study Start

March 1, 2021

Primary Completion

May 28, 2022

Study Completion

June 3, 2022

Last Updated

August 23, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations