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临床试验/NCT07295912
NCT07295912已完成不适用

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

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2023年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
1
主要终点
Cognitive Planning

研究概览

简要总结

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. . 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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
8 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Potential participants were recruited from the local special schools for intellectual disabilities. They werescreened with the following inclusion and

排除标准

  • The inclusion criteria are:
  • 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).
  • Exclusion criteria are:
  • 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).

结局指标

主要结局

Cognitive Planning

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • Heart Rate Variability(Baseline (T1: day 1), 4th Intervention Session (T2: day 4), 8th Intervention Session (T3: day 8))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

TSE CHOI YEUNG ANDY

Associate Professor

Chinese University of Hong Kong

研究点 (1)

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