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Autism Spectrum Disorder (ASD)Cycling&AutismNCT07295912

Cycling Interventions on Cognition in Children With Autism

A study testing Learning to Bicycle, Bicycle Treadmill and Cycling with Training Wheels in people with Autism Spectrum Disorder (ASD), run by Chinese 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

The goal of this clinical trial was to determine if a specific type of cycling exercise improved executive functions in school-aged children with autism spectrum disorder (both boys and girls, aged 8-10 years, no healthy volunteers). The main questions it addressed were: 1. . Read more about this study

Who is it for?
Ages 8 to 10 years
Conditions the study is for
Autism Spectrum Disorder (ASD)
What is being tested?
Learning to Bicycle, Bicycle Treadmill and Cycling with Training Wheels
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteHong Kong
Study dates
1 Jan 2023to 31 Dec 2024
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 8 to 10 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

None listed.

Who cannot join

  • color blindness reported by parents;
  • history of other medical conditions that limit physical exercise capacities (e.g., asthma, seizure, cardiac disease);
  • history of brain injury including concussions, other complex neurologic disorders (e.g., epilepsy, phenylketonuria, fragile X syndrome);
  • on current or recent use of antidepressants and other psychotropic medications known to alter peripheral BDNF levels;
  • medical conditions of the bladder;
  • obesity (i.e. >95th percentile of age-gender specific BMI cutoff).

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site
  • Chinese University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

Official title: Why Does Learning to Ride a Bike Improve Executive Functions in Children With ASD?

The goal of this clinical trial was to determine if a specific type of cycling exercise improved executive functions in school-aged children with autism spectrum disorder (both boys and girls, aged 8-10 years, no healthy volunteers).

The main questions it addressed were:

Read more
  1. . Did learning to ride a real bicycle improve planning, flexibility, working memory, and inhibition more than stationary cycling?
  2. .Was the benefit driven by (A) dynamic balance, (B) spatial updating, or both?

Researchers compared four arms to identify if dynamic balance and/or spatial updating were the active components using three interventions groups, namely learning to bicycle (LTB), bicycle treadmill (BT), cycling with training wheels (TW)-and one active control group (stationary cycling, SC).

Participants:

  1. . Provided a small urine sample three times for BDNF brain-marker testing.
  2. . Played four short tablet games (10 minutes each) at 1st intervention session , 4th intervention session and 8th intervention session to assess their Executive Functions.
  3. . Attended four 45-minute cycling sessions per week for 2 weeks at their respective school.
  4. .Continued all usual therapies; no medicine was administered

The trial was completed on 31 December 2024 (RGC Ref 18616522, HREC 2021-2022-0397).

Read the detailed description

BACKGROUND Executive functions (EF)-planning, cognitive flexibility, working memory, and inhibition-were markedly impaired in autism spectrum disorder (ASD). A 2021 pilot RCT by the same team (Med Sci Sports Exerc 2021;53:1417-24) demonstrated that only children who learned to ride a real bicycle (n=24) improved EF; stationary cycling did not. The cognitive gain therefore stemmed from skill acquisition, not aerobic fitness alone.

HYPOTHESIS

Improvements were driven by two mechanisms recruited during real-bike learning:

(A) dynamic balance (vestibular/proprioceptive load) (B) spatial updating during self-produced translation through space

TRIAL DESIGN This study was a four-arm randomized controlled trial (RCT) with equal allocation to three intervention groups-learning to bicycle (LTB), bicycle treadmill (BT), cycling with training wheels (TW)-and one active control group (stationary cycling, SC). Assessments were conducted at baseline (T1), mid-intervention (T2, one week), and post-intervention (T3, 2 weeks) to evaluate executive function (EF), BDNF and HRV.

Data Collection Each participant was asked to perform a set of neuropsychological assessments, where different EF components were recorded. Each assessment was lasted for 15 minutes followed by a 5-minute break to prevent cognitive fatigue in the participants. The neuropsychological assessments were conducted one hour before the commencement of the first exercise intervention (T1: baseline), the 4th intervention (T2: mid-intervention) and the last exercise intervention (T3: post-intervention). The mid-assessment provides valuable information about how much variance in EF is accounted for by variance in HRV records. The HRV assessment was conducted 10 minutes after the end of the first (T1), 4th (T2), and last (T3) interventions using Garmin Venus 2S watch, a wrist-based device validated for short-term HRV recordings. During a 5-minute seated rest period in a quiet environment, participants were asked to perform an on-demand Health Snapshot test (2-minute) to capture parasympathetic recovery post-exercise. To ensure comfortability and data quality, children were instructed to wear the Garmin Venus 2 watch only during the rest period and were asked to remain still and breathe naturally. The Garmin Venu 2's Elevate V4 optical heart rate sensor recorded inter-beat interval data, which were processed by the Garmin Connect app to compute RMSSD, These procedures were standardized across groups to minimize variability due to environmental or procedural factors. Meanwhile, urine samples from the participants were collected in 120-ml sterile cups at T1, T2 and T3. Upon completion, the samples were promptly transported from participants' homes to the laboratory of the Department of Chemical Pathology located at Princes Wales Hospital .

PARTICIPANTS Sixty-two participants with mild to moderate ASD, aged 8-12 years, were recruited from a special school for intellectual disabilities, Chinese YMCA of Hong Kong and a cycling company in Hong Kong with existing research links to the study team. Inclusion criteria were: (1) ASD diagnosis per DSM-5 and ADOS-2; (2) non-verbal IQ >40 (Wechsler Intelligence Scale for Children revised in China); (3) ability to follow instructions and perform interventions/assessments with assistance; (4) no additional regular physical activity (beyond school physical education) for 2 months prior; and (5) novice at two-wheel bicycle riding (<10 seconds independent riding). Exclusion criteria included: (1) color blindness; (2) medical conditions limiting exercise (e.g., asthma, seizures); (3) history of brain injury or complex neurologic disorders and (4) obesity [>95th percentile BMI]. Screening was conducted by a psychologist and a psychiatric physician, with parent-reported autistic traits assessed via the Social Responsiveness Scale, Second Edition (SRS-2). After screening, fifty-six eligible participants were randomized to one of four groups using block randomization (block size = 4) to ensure equal allocation. Upon the completion of the study, participant numbers per group were: LTB (n=13, 1 dropout at T2), BT (n=12, 2 dropouts at T2), TW (n=14), and SC (n=12, 2 dropouts at T2).

INTERVENTIONS All interventions were lasted for 2 weeks, comprising 8 sessions (4 sessions per week, 45 minutes each) in school halls/gymnasiums, led by a qualified cycling coach (Hong Kong Cycling Association) assisted by student helpers (1:1 staff-to-participant ratio). Each intervention session consisted of a 10-minute preparation and warm-up, 30-minute cycling training, and 5-minute cool-down. Exercise intensity was monitored by asking participants every 10 minutes during exercise to indicate their ratings of perceived exertion (target range:3-5). Cycling distance was measured by speedometers for non-stationary groups (LTB, TW) to ensure equivalent spatial exposure. Participants were positively reinforced verbally with compliments for their efforts during the interventions and their improvements were visualized through graphs kept in the child's bedroom at home (e.g., list of achievements: distance; able to use another set of wheels and able to self-launch). For the stationary cycling group, participants were provided a graph of the cumulative total time spend cycling or the equivalent distance. Apart from the LTB group, all participants in the other groups were taught how to ride a bicycle after T3 to recognize their contributions in the study.

Learning to Bicycle (LTB): Participants were asked to ride on a normal bicycle with training wheels. Participants were then progressed to a two-wheel bicycle. To keep participants on the learning curve, in case the participants have successfully mastered the cycling skill before the end of the intervention period, they were asked to ride through an obstacle course that WAS progressively more difficult to navigate. The obstacle course was designed by a focus group, which consisted of four physical education teachers from participating schools and one experienced cycling coach with more than 5 years of coaching experience.

Bicycle Treadmill (BT): Participants in this group first learned how to ride a normal bicycle with its back wheel and training wheels on a roller and the front wheel on the holder stand. Then they were progressed to ride the two-wheel bicycle with its back wheel on a roller (no training wheels), and finally to the conventional two-wheel bicycle on the rollers.

Cycling with Training Wheels (TW): Participants in this group were asked to ride a bicycle with training wheels throughout the whole study. They also rode through an obstacle course as they became more proficient at riding.

Stationary Cycling (SC): Participants in the group were asked to cycle on a stationary bicycle, with progress tracked via cumulative time/distance graphs.

TRIAL STATUS Recruitment: 62/62 (completed 30 Jun 2023) Last participant last visit: 30 Jun 2023 Data lock: 31 Aug 2024 Primary manuscript will be submitted to Autism Journal for review.

SAFETY No serious adverse events occurred; minor grazes (n=1) were treated on-site.

FUNDING \& ETHICS Funded by RGC General Research Fund 18616522 (HK$814,430). Approved by HREC-EdUHK 2021-2022-0397 (15 Jun 2022).

Being tested
Learning to Bicycle, Bicycle Treadmill, Cycling with Training Wheels, Stationary Cycling
Keywords
autism spectrum disorder, executive function, cycling, dynamic balance, spatial updating, randomized controlled trial, children, BDNF, actigraph
Medical subject headings
Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Learning to BicycleBehavioural

    Also called LTB

    2 weeks, 4×45 min/week. Progressive removal of stabilisers on 16-inch bikes. Recruited both dynamic balance and spatial updating during real locomotion.

  • Bicycle TreadmillBehavioural

    Also called BT

    2 weeks, 4×45 min/week. Bike fixed on smart rollers. Recruited dynamic balance only.

  • Cycling with Training WheelsBehavioural

    Also called TW

    2 weeks, 4×45 min/week. Fixed stabilisers. Recruits spatial updating only.

  • Stationary CyclingBehavioural

    Also called SC

    2 weeks, 4 ×45 min/week. Monark ergometer. Active control; recruited NEITHER dynamic balance nor spatial updating mechanism.

Study groups in NCT07295912
Study groupRoleWhat they receive
Learning to BicycleExperimentalParticipants were asked to ride on a normal bicycle with training wheels. Participants were then progressed 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 navigate.
Receives: Behavioral: Learning to Bicycle
Bicycle TreadmillExperimentalParticipants in this group first learned how to ride a normal bicycle with its back wheel and training wheels on a roller and the front wheel on the holder stand. Then they were progressed to ride the two-wheel bicycle with its back wheel on a roller (no training wheels), and finally to the conventional two-wheel bicycle on the rollers.
Receives: Behavioral: Bicycle Treadmill
Cycling with Training WheelsExperimentalParticipants in this group were asked to ride a bicycle with training wheels throughout the whole study. They also rode through an obstacle course as they became more proficient at riding.
Receives: Behavioral: Cycling with Training Wheels
Stationary CyclingActive comparatorParticipants in the group were asked to cycle on a stationary bicycle, with progress tracked via cumulative time/distance graphs.
Receives: Behavioral: Stationary Cycling

What is being measured

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

  1. Cognitive Planning

    Planning: Participant's ability to plan was assessed using computerized PEBL Tower of London (PEBL TOL) task. Participants were presented a sequence of three different colored balls on three pegs of different lengths on a computer screen. During each of the 12 trials, participants were instructed to move the balls using a computer mouse to match the target peg arrangement in a minimum amount of moves according to the pre-specified rules. The level of the task difficulty and the restriction on number of moves were progressively higher over time. If there were three consecutive failed trial attempts, the task was halted. Scores for children's general planning ability were calculated by summing the correct tasks performed out of the 12 trials given, and the total score ranges from 0 to 36. Higher scores indicated better planning.

    Measured: Baseline (T1: day 1), 4th Intervention Session (T2: Day 4), 8th Intervention Session (T3: Day 8)

  2. Working Memory

    Working memory: Participants' visual-spatial working memory was evaluated using the Corsi block tapping task. In the CBTT, participants observed and replicated a sequence of tapped blocks, starting with three blocks. Sequence length increased by one after every two trials. The task ended after two incorrect sequences of the same length, with the longest correctly repeated sequence recorded as the score. Higher scores indicated better working memory.

    Measured: Baseline (T1: day 1), 4th Intervention Session (T2: day 4), 8th Intervention Session (T3: day 8)

  3. Inhibition

    The participants' ability to inhibit unwanted responses to changing stimuli was measured by a computerized Go/No-go (GNG) task. In the task, participants pressed a left or right key for corresponding arrows (Go response) but withheld responses for up arrows (No-go response). After 20 practice trials, they completed 300 trials: 220 Go trials (110 left, 110 right) and 80 No-go trials (26.7%), which were presented randomly via E-Prime 3.0 software. Each stimulus appeared for 500 ms, followed by a 1000 ms blank interval. Breaks of 2 minutes were offered after every 60 trials. No feedback was provided, and response times were recorded but not analyzed due to unreliable recording . False alarms (FA), defined as Go responses on No-go trials, measured inhibition, with lower FA rates indicating better inhibitory control.

    Measured: Baseline (T1: day 1), 4th Intervention Session (T2: day 4), 8th Intervention Session (T3: day 8)

  4. Flexibility

    Children's Color Trail Making Test (CCTT) was employed to assess cognitive flexibility of the participants. Participants completed two parts of the TMT as quickly and accurately as possible. In Part 1 (CCTT-1), they connected numbered circles in ascending order using a single color (e.g., black 1-2-3). In Part 2 (CCTT-2), they alternated between connecting numbered circles of two colors (e.g., black 1, yellow 2, pink 3), requiring task-switching between color sets. Cognitive flexibility was quantified by the interference score, which was calculated by the difference of time between Part 2 and Part 1 (i.e. CCTT-2 minus CCTT-1), where lower scores indicate better cognitive flexibility, reflecting enhanced ability to shift between mental sets.

    Measured: Baseline (T1), 4th Intervention Session (T2), 8th Intervention Session (T3)

  5. Urinary BDNF level

    Urine samples from the participants were collected in 120-ml sterile cups . Upon completion, the samples were promptly transported from participants' homes to the laboratory of the Department of Chemical Pathology located at Princes Wales Hospital.

    Measured: Baseline (T1: day 1), 4th Intervention Session (T2: day 4), 8th Intervention Session (T3: day 8)

Secondary outcomes (1)
  1. Heart Rate Variability

    The HRV assessment was conducted using Garmin Venus 2S watch, a wrist-based device validated for short-term HRV recordings. During a 5-minute seated rest period in a quiet environment, participants were asked to perform an on-demand Health Snapshot test (2-minute) to capture parasympathetic recovery post-exercise. To ensure comfortability and data quality, children were instructed to wear the Garmin Venus 2 watch only during the rest period and were asked to remain still and breathe naturally. The Elevate V4 optical heart rate sensor of the Garmin watch recorded inter-beat interval data, which were processed by the Garmin Connect app to compute RMSSD (Garmin, 2025),

    Measured: Baseline (T1: day 1), 4th Intervention Session (T2: day 4), 8th Intervention Session (T3: day 8)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2025
  2. Study start1 Jan 2023
  3. Primary completion30 Jun 2024
  4. Study completion31 Dec 2024

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07295912
Sponsor's protocol ID
2021-2022-0397
Other IDs
18616522
Acronym
Cycling&Autism
Status last verified
Dec 2025
First submitted
4 Dec 2025
Last updated
22 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: According to the ethical approval form, we must not share any individual participant data to anyone other than the research team members.

Publications

  • Ng JSK, Chau JPC, Chan AWK, Lui JKC, Cheng JWCH. A Nurse-Led Web-Based Home Asthma Education Program for Children and their Families: A Randomized Controlled Trial. J Pediatr Nurs. 2021 Jul-Aug;59:158-163. doi: 10.1016/j.pedn.2021.04.014. Epub 2021 Apr 21.

    PubMed 33894543
  • Tse ACY, Lee PH, Poon ETC, Ho AWY, Sun FH, Poon K, Ip PPK, Anderson DI. Cycling Interventions Enhance Executive Function in Children with Autism via Heart Rate Variability Mediation: A Randomized Controlled Trial. Sports Med Open. 2026 Apr 10;12(1):41. doi: 10.1186/s40798-026-01019-8.

    PubMed 41963669

Questions about this trial

What is this clinical trial studying?

A study testing Learning to Bicycle, Bicycle Treadmill and Cycling with Training Wheels in people with Autism Spectrum Disorder (ASD), run by Chinese 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 0 inclusion and 6 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 22 Dec 2025. 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?

Cognitive Planning (time frame: Baseline (T1: day 1), 4th Intervention Session (T2: Day 4), 8th Intervention Session (T3: Day 8)). 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?

On the ClinicalTrials.gov record for NCT07295912, which also lists 2 linked publications.

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 22 Dec 2025.

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