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FMS - 改善自闭症谱系障碍学龄前儿童入学准备度的CrossFit训练计划(FCTP)

2026年5月22日 更新者：Peking University

一项关于FMS-CrossFit训练计划（FCTP）改善自闭症谱系障碍学龄前儿童入学准备的随机对照试验

自闭症谱系障碍（ASD）日益成为公共卫生关注焦点，学龄前儿童常表现出入学准备方面的持续不足。 然而，针对性的、发展全面的干预措施仍然有限。 这项随机对照试验将评估一项为期12周的基础运动技能-交叉健身训练计划（FCTP），研究对象为184名3-6岁的ASD儿童，并与常规治疗（TAU）对照组进行比较。 该计划将渐进式基础运动技能训练与交叉健身式循环训练相结合，旨在提升运动能力、社交互动和自我调节能力。 主要结局指标侧重于通过优势与困难问卷（SDQ）评估的入学准备情况，次要结局指标包括运动发展、执行功能、社交反应性和生物标志物。 评估将在基线、干预中期（8周）、干预后（12周）和随访期（20周）进行。

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Autism spectrum disorder (ASD) is a major public health concern, and increasing prevalence underscores the need for evidence-based interventions that improve functional outcomes. While school readiness is a critical developmental milestone, deficits remain pervasive among preschoolers with ASD, yet targeted interventions remain scarce. Exercise interventions grounded in Fundamental Movement Skills (FMS) are promising, but many existing approaches lack systematic progression and do not adequately address the multidimensional nature of school readiness.

This randomized controlled trial will evaluate the effectiveness of a novel Fundamental Movement Skills-CrossFit Training Program (FCTP) in 184 preschool children with ASD aged 3-6 years. Participants will be randomly assigned to the FCTP intervention group or a Treatment As Usual (TAU) control group using a computer-generated randomization. The FCTP is a 12-week structured program integrating FMS development through CrossFit-style circuit training, designed to enhance motor competence, social interaction, and self-regulation skills essential for school readiness. Primary outcomes will include school readiness measures assessed using the Strengths and Difficulties Questionnaire (SDQ). Secondary outcomes will encompass motor development, executive function, social responsiveness, and biomarker analyses. Assessments will be conducted at baseline, 8 weeks (mid-intervention), 12 weeks (end-of-intervention), and 20 weeks (8 weeks post-intervention).

Discussion: This study will address a critical gap in early intervention research by targeting school readiness through a systematic, theory-driven approach combining motor skill development with social learning opportunities. The FCTP will offer several advantages over traditional interventions: systematic FMS progression, group-based social interaction, cost-effectiveness, and high implementation feasibility. By integrating neuroplasticity principles with contextual learning, this intervention will provide a comprehensive approach to preparing children with ASD for successful educational transitions.

研究类型

介入性

注册 (估计的)

184

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Fujian
      • Fuzhou、Fujian、中国、350001
        • 招聘中
        • Fujian Provincial Maternity and Children's Hospital
        • 接触：
        • 首席研究员：
          • Xinxin Huang, master

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不

描述

纳入标准：

  1. 年龄3-6岁；
  2. 根据《精神障碍诊断与统计手册》第五版（DSM-5）标准或《自闭症诊断观察量表》第二版（ADOS-2）确诊为自闭症谱系障碍；
  3. 能够理解基本的口头指令；
  4. 父母/监护人签署书面知情同意书。

排除标准：

  1. 过去6个月内参与过结构化运动项目；
  2. 合并严重神经系统疾病（如癫痫、苯丙酮尿症、脆性X综合征、结节性硬化症）或主要精神疾病（如精神分裂症、双相情感障碍）；
  3. 视觉、听觉或智力障碍可能影响参与；
  4. 有重大头部创伤或脑损伤史；
  5. 存在身体活动的医学禁忌症；
  6. 研究团队认为不适合参与项目的其他因素。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：FCTP干预组
FCTP干预组的参与者将每周接受两次监督下的新型基础运动技能-交叉训练计划（FCTP）课程，以替代传统的感官整合疗法。
行为的：FCTP program

Each session consists of three parts: warm up (5 minutes), basic motor skills training (25 minutes) and cool-down with stretching (5 minutes). The program combines physical, social, linguistic and communication skills training aspects, and can be divided into three phases (about 2 to 4 weeks for each phase) to achieve different targets.

Stage 1: Basic Motor Skills Learning Stages:

This stage primarily focuses on low-intensity activities over a period of 1 to 3 weeks.

Stage 2: Basic Motor Skills Proficiency Stage:

This stage is characterized by low to moderate intensity and typically lasts for 4 to 7 weeks.

Stage 3: Basic Motor Skills Enhancement stage:

This stage is conducted at a moderate intensity and focuses on the intensive development of motor skills over a period from 8 to 12 weeks.

其他名称：
  • 基础运动技能-CrossFit训练计划
有源比较器：control group
The control group receives treatment as usual (TAU), allowing participants to engage in routine services of their choice, including sensory integration therapy, social skills training, language intervention, transcranial magnetic stimulation (TMS), etc.
行为的：treatment as usual (TAU) (Control Group)
The control group receives treatment as usual (TAU), allowing participants to engage in routine services of their choice, including sensory integration therapy, social skills training, language intervention, Transcranial Magnetic Stimulation (TMS), etc.
其他名称：
  • 照常治疗

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
School readiness
大体时间：baseline, 8 weeks post-baseline, post-intervention (12 weeks), follow-up (20 weeks)
The Strengths and Difficulties Questionnaire (SDQ) was used to assess school readiness. The Total Difficulties Score ranges from 0 to 40, with higher scores indicating more severe difficulties in the child.
baseline, 8 weeks post-baseline, post-intervention (12 weeks), follow-up (20 weeks)
Gross Motor Development
大体时间：baseline, post-intervention (12 weeks)
The Test of Gross Motor Development - 3rd edition (TGMD-3) is a measure of fundamental motor skills.
baseline, post-intervention (12 weeks)

次要结果测量

结果测量
措施说明
大体时间
Neuropsychological assessment
大体时间：baseline, post-intervention (12 weeks)
The Early Years Toolbox (EYT) is a low-cost iPad software to assess young children's expressive language, executive function, and social development.
baseline, post-intervention (12 weeks)
Severity of autism
大体时间：baseline, post-intervetion (12 weeks)
The Autism Behavior Checklist (ABC) is a widely used screening instrument comprising 57 items that characterize behavioral features of children with autism. The scores range from 0 to 228, with higher scores indicating greater symptom severity in the child.
baseline, post-intervetion (12 weeks)
Executive function
大体时间：baseline, 8 weeks post-baseline, post-intervention (12 weeks), follow-up (20 weeeks)
The Behavior Rating Inventory of Executive Function (BRIEF) is an 86-item in five subscales screening for executive function impairment in ages 5-18 years. The Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P) is a validated tool for assessing executive function in children aged 2-5 based on daily behaviors. The scores range from 0 to 189, with higher scores indicating greater symptom severity in the child.
baseline, 8 weeks post-baseline, post-intervention (12 weeks), follow-up (20 weeeks)
Caregiver burden
大体时间：baseline, 8 weeks post-baseline, post intervention(12 weeks), follow up(20 weeks)
Zarit Caregiver Burden Interview is a widely used tool for measuring caregiver burden. The scores range from 0 to 16, with higher scores indicating greater burden.
baseline, 8 weeks post-baseline, post intervention(12 weeks), follow up(20 weeks)
Sleeping conditions
大体时间：baseline, 8 weeks post-baseline, post-intervention (12 weeks)
The Children's Sleep Habits Questionnaire (CSHQ) comprises eight subscales that assess different aspects of sleep behaviors. The scores range from 0 to 99, with higher scores indicating greater symptom severity in the child.
baseline, 8 weeks post-baseline, post-intervention (12 weeks)
Appetite status
大体时间：baseline, 8 weeks post-baseline, post-intervention (12 weeks)
The initiative eating subscale of the Chinese Preschoolers' Eating Behavior Questionnaire (CPEBQ-IE) has 7 questions that assess the active eating behaviors of preschool children. The scores range from 0 to 20, with lower scores indicating greater symptom severity in the child.
baseline, 8 weeks post-baseline, post-intervention (12 weeks)
Social responsiveness
大体时间：baseline, 8 weeks post-baseline, post-intervention (12 weeks)
The social responsiveness scale-2 (SRS-2) is a 65-item parent-reported questionnaire designed to measure the severity of autism symptoms as a quantitative trait. The scores range from 0 to 195, with higher scores indicating more severe problems in the child.
baseline, 8 weeks post-baseline, post-intervention (12 weeks)
Gastrointestinal issues
大体时间：baseline, 8 weeks post-baseline, post-intervention (12 weeks)
The 6-item Gastrointestinal Severity Index (6-GSI) is employed for evaluating gastrointestinal symptoms. The scores range from 0 to 12, with higher scores indicating greater symptom severity in the child.
baseline, 8 weeks post-baseline, post-intervention (12 weeks)

其他结果措施

结果测量
措施说明
大体时间
Bio samples
大体时间：baseline, post-intervention(12 weeks)
an additional 10 ml of urine will be collected for transcriptomic and metabolomic analyses, aiming to identify key biomarkers associated with screening outcomes and intervention efficacy.
baseline, post-intervention(12 weeks)
Semi-structured interviews
大体时间：baseline, post-intervetion (12 weeks)
Semi-structured interviews will explore economic indicators such as time and financial costs, as well as parents' and rehabilitation therapists' suggestions and reflections on the intervention process.
baseline, post-intervetion (12 weeks)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Peking University

调查人员

  • 首席研究员：Yuelong Ji, PHD、Peking University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年11月22日

初级完成 (估计的)

2026年11月24日

研究完成 (估计的)

2027年4月24日

研究注册日期

首次提交

2026年4月8日

首先提交符合 QC 标准的

2026年4月8日

首次发布 (实际的)

2026年4月15日

研究记录更新

最后更新发布 (实际的)

2026年5月27日

上次提交的符合 QC 标准的更新

2026年5月22日

最后验证

2026年2月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IRB00001052-25110-A01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

由于保护参与者隐私和保密性的原因，IPD将不会被共享。 知情同意书未包含研究团队之外的数据共享条款，且相关数据保护法规禁止传播可识别的个人健康信息。

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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