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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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
- . Did learning to ride a real bicycle improve planning, flexibility, working memory, and inhibition more than stationary cycling?
- .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:
- . Provided a small urine sample three times for BDNF brain-marker testing.
- . Played four short tablet games (10 minutes each) at 1st intervention session , 4th intervention session and 8th intervention session to assess their Executive Functions.
- . Attended four 45-minute cycling sessions per week for 2 weeks at their respective school.
- .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).
- Conditions
- Autism Spectrum Disorder (ASD)
- 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 group | Role | What they receive |
|---|---|---|
| Learning to Bicycle | Experimental | 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, they were asked to ride through an obstacle course that was progressively more difficult to navigate. Receives: Behavioral: Learning to Bicycle |
| Bicycle Treadmill | Experimental | 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. Receives: Behavioral: Bicycle Treadmill |
| Cycling with Training Wheels | Experimental | 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. Receives: Behavioral: Cycling with Training Wheels |
| Stationary Cycling | Active comparator | Participants 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.
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)
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)
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)
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)
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)
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.
- First posted22 Dec 2025
- Study start1 Jan 2023
- Primary completion30 Jun 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum Disorder (ASD)Studies of the same condition, open and under way.
- More trials run by Chinese 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- San Francisco State University, United Christian Hospital, University of Leicester, Education University of Hong Kong
- Responsible party
- Principal investigator, TSE CHOI YEUNG ANDY, Chinese University of Hong Kong
- Investigators
- Andy Choi-Yeung Tse, PhD, Principal investigator, Chinese University of Hong Kong
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 33894543Tse 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Why Does Learning to Ride a Bike Improve Executive Functions in Children With ASD?
- ClinicalTrials.gov ID
- NCT07295912
- Acronym / sponsor ID
- Cycling&Autism / 2021-2022-0397
- Conditions
- Autism Spectrum Disorder (ASD)
- Keywords
- autism spectrum disorder, executive function, cycling, dynamic balance, spatial updating, randomized controlled trial, children, BDNF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- San Francisco State University, United Christian Hospital, University of Leicester, Education University of Hong Kong
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 22 Dec 2025 (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.
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:
- . Did learning to ride a real bicycle improve planning, flexibility, working memory, and inhibition more than stationary cycling?
- .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:
- . Provided a small urine sample three times for BDNF brain-marker testing.
- . Played four short tablet games (10 minutes each) at 1st intervention session , 4th intervention session and 8th intervention session to assess their Executive Functions.
- . Attended four 45-minute cycling sessions per week for 2 weeks at their respective school.
- .Continued all usual therapies; no medicine was administered
The trial was completed on 31 December 2024 (RGC Ref 18616522, HREC 2021-2022-0397).
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Learning to Bicycle | Experimental | Behavioral: Learning to BicycleParticipants 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. |
| Bicycle Treadmill | Experimental | Behavioral: Bicycle TreadmillParticipants 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 | Experimental | Behavioral: Cycling with Training WheelsParticipants 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 | Active comparator | Behavioral: Stationary CyclingParticipants in the group were asked to cycle on a stationary bicycle, with progress tracked via cumulative time/distance graphs. |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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;
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 |
|---|---|---|
| Learning to BicycleAlso: LTB2 weeks, 4×45 min/week. Progressive removal of stabilisers on 16-inch bikes. Recruited both dynamic balance and spatial updating during real locomotion. | Behavioural | Learning to Bicycle |
| Bicycle TreadmillAlso: BT2 weeks, 4×45 min/week. Bike fixed on smart rollers. Recruited dynamic balance only. | Behavioural | Bicycle Treadmill |
| Cycling with Training WheelsAlso: TW2 weeks, 4×45 min/week. Fixed stabilisers. Recruits spatial updating only. | Behavioural | Cycling with Training Wheels |
| Stationary CyclingAlso: SC2 weeks, 4 ×45 min/week. Monark ergometer. Active control; recruited NEITHER dynamic balance nor spatial updating mechanism. | Behavioural | Stationary Cycling |
Primary outcome
Cognitive Planning
Time frame: Baseline (T1: day 1), 4th Intervention Session (T2: Day 4), 8th Intervention Session (T3: Day 8)
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.
Working Memory
Time frame: Baseline (T1: day 1), 4th Intervention Session (T2: day 4), 8th Intervention Session (T3: day 8)
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.
Inhibition
Time frame: Baseline (T1: day 1), 4th Intervention Session (T2: day 4), 8th Intervention Session (T3: day 8)
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.
Flexibility
Time frame: Baseline (T1), 4th Intervention Session (T2), 8th Intervention Session (T3)
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.
Urinary BDNF level
Time frame: Baseline (T1: day 1), 4th Intervention Session (T2: day 4), 8th Intervention Session (T3: day 8)
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.
1 secondary outcome
Heart Rate Variability
Time frame: Baseline (T1: day 1), 4th Intervention Session (T2: day 4), 8th Intervention Session (T3: day 8)
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 22 Dec 2025.
- Background: PubMed 33894543Ng 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.
- Derived from this study: PubMed 41963669Tse 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.
- Individual participant dataSharing planned: No. According to the ethical approval form, we must not share any individual participant data to anyone other than the research team members.
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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.
Andy Choi-Yeung Tse, PhD principal investigator
Chinese 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 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.