Cycling Interventions on Cognition in Children With Autism

NCT07295912 | Completed

• 2 other identifiers: 2021-2022-039718616522
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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. 1.. Did learning to ride a real bicycle improve planning, flexibility, working memory, and inhibition more than stationary cycling?
2. 2..Was the benefit driven by (A) dynamic balance, (B) spatial updating, or both?
3. 3.. Provided a small urine sample three times for BDNF brain-marker testing.
4. 4.. Played four short tablet games (10 minutes each) at 1st intervention session , 4th intervention session and 8th intervention session to assess their Executive Functions.
5. 5.. Attended four 45-minute cycling sessions per week for 2 weeks at their respective school.
6. 6..Continued all usual therapies; no medicine was administered

Conditions

Autism Spectrum Disorder (ASD)

Keywords

autism spectrum disorder; executive function; cycling; dynamic balance; spatial updating; randomized controlled trial; children; BDNF; actigraph

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

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

Secondary Outcomes (1)

• Heart Rate Variability

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

Study Arms (4)

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.

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.

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.

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.

Behavioral: Stationary Cycling

Interventions

Learning to Bicycle BEHAVIORAL

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

Also known as: LTB

Learning to Bicycle

Bicycle Treadmill BEHAVIORAL

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

Also known as: BT

Bicycle Treadmill

Cycling with Training Wheels BEHAVIORAL

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

Also known as: TW

Cycling with Training Wheels

Stationary Cycling BEHAVIORAL

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

Also known as: SC

Stationary Cycling

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• age 8 - 10 years;
• mild to moderate ASD 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 70 using a brief version of Wechsler intelligence scale for children (Chinese revised);
• able to follow instructions with the assistance of research staff;
• able to perform the requested physical activity intervention and executive function measures with the assistance of research staff;
• no additional regular participation in physical activity other than school physical education classes for at least 3 months prior to the study;
• (6) novice at riding a two-wheel bicycle (i.e., cannot ride the bicycle alone for more than 10 consecutive seconds).
• 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).

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• San Francisco State University: collaborator
• United Christian Hospital: collaborator
• University of Leicester: collaborator
• Education University of Hong Kong: collaborator

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 33894543 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Andy Choi-Yeung Tse, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 22, 2025
• Study Start: January 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)