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This Study Will Evaluate Cardiorespiratory and Muscular Fitness to Examine Associations With Anthropometric Characteristics and Other Indicators of Cardiometabolic Risk Among Patients With or Without Autism Spectrum Disorder (ROACH)

2026年8月31日 更新者:Aaron P. Meadows、University of Virginia

Cardiorespiratory Fitness, Handgrip Strength, and Cardiometabolic Health in Obese Children With or Without Autism Spectrum Disorder: a Retrospective Cohort Study

The goal of this observational study is to evaluate cardiorespiratory and muscular fitness in children with obesity, with and without autism spectrum disorder (ASD), and examine how fitness relates to body measurements, body composition, and cardiometabolic health. The main questions it aims to answer are:

  • Do children with and without ASD differ in cardiorespiratory fitness and handgrip strength?
  • Are fitness levels related to body composition and measures of cardiometabolic health?

Researchers will compare children with ASD to children without ASD to see if there are differences in fitness, body composition, and cardiometabolic health.

Participants will have information from their medical records reviewed, including:

  • Cardiorespiratory fitness and handgrip strength test results
  • Height, weight, BMI, and body composition measurements
  • Blood test results, including HbA1c and cholesterol levels
  • Age, sex, and other demographic information

研究概览

详细说明

Pediatric obesity and cardiometabolic health problems are major public health concerns. Children with obesity may have a higher risk of developing conditions such as insulin resistance, prediabetes, abnormal cholesterol levels, high blood pressure, and cardiovascular disease later in life. In clinical practice, body mass index (BMI), body measurements, and blood tests are commonly used to assess health risk. Although these measures provide important information, they do not fully describe how well a child's heart, lungs, and muscles work during physical activity. Cardiorespiratory fitness (CRF) provides information about the body's ability to use oxygen during exercise and reflects the combined function of several body systems. Higher levels of CRF have been associated with better cardiometabolic health and a lower risk of future disease.

Fitness testing is not routinely used in pediatric clinical settings. Traditional CRF testing may require specialized equipment and exercise at maximal intensity, which can be difficult for some children and may not be practical during a routine clinic visit. Simple, clinically feasible tests, such as the 3-minute step test (3MST), may provide a practical way to assess cardiorespiratory fitness without requiring expensive equipment or maximal exercise. Handgrip strength (HGS) testing is another simple measure that can provide information about muscular fitness and physical function. These tests may be especially useful in pediatric populations because they can be completed in a relatively short period of time and require limited equipment.

Research has shown that cardiorespiratory and muscular fitness are related to several measures of cardiometabolic health, including body composition, blood glucose, cholesterol levels, and other risk factors for metabolic and cardiovascular disease. However, less is known about how these fitness measures relate to cardiometabolic health in children with obesity who are evaluated in routine clinical care, particularly among children with autism spectrum disorder (ASD). Children with ASD may have differences in physical activity, motor skills, and participation in exercise that could affect fitness and cardiometabolic health.

This study will examine cardiorespiratory and muscular fitness in children with obesity, with and without ASD. The study will evaluate whether differences in fitness are associated with body measurements, body composition, and markers of cardiometabolic health, including blood glucose and lipid measures. The findings may improve understanding of the relationship between physical fitness and cardiometabolic health in children with obesity and may help determine whether simple fitness assessments can provide useful information during pediatric clinical evaluations. In the future, these assessments may support more individualized exercise recommendations and contribute to strategies for improving long-term cardiometabolic health in children.

研究类型

观察性的

注册 (估计的)

200

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

    • Virginia
      • Charlottesville、Virginia、美国、22903
        • 招聘中
        • UVA Health
        • 接触:
        • 接触:
        • 首席研究员:
          • Aaron Meadows, MMed

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
  • 成人

接受健康志愿者

不

取样方法

非概率样本

研究人群

Obese Pediatrics with or without Autism Spectrum Disorder

描述

Inclusion Criteria:

  • Pediatric patients 6-18 years of age who received care at the Pediatric Endocrinology Diabetes Prevention and Fitness Clinic between January 1 and December 31, 2026.
  • BMI ≥95th percentile for age and sex, consistent with the definition of pediatric obesity.
  • Documented results from cardiorespiratory fitness testing and/or handgrip strength testing.
  • Documented HbA1c value, when available.
  • Sufficient medical record information to determine ASD status and the primary study outcomes.

Exclusion Criteria:

  • Age <6 or >18 years at the time of clinical assessment.
  • BMI <95th percentile for age and sex.
  • Absence of documented cardiorespiratory fitness or handgrip strength testing.
  • Insufficient medical record information to determine ASD status or primary study outcomes.
  • Duplicate or unusable medical records.

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

队列和干预

团体/队列
Pediatrics with Autism Spectrum Disorder
Obese and Prediabetic
Pediatrics without Autism Spectrum Disorder
Obese and Pediatric

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
Cardiorespiratory Fitness
大体时间:January 1 - December 31 2026
Cardiorespiratory Fitness as determined by 3-minute step test results, which includes post 1-minute heartrate per Kasch Pulse Recovery Test
January 1 - December 31 2026
Handgrip Strength
大体时间:January 1 - December 31 2026
As defined by handgrip test using hand dynamometer in kilograms
January 1 - December 31 2026
Aerobic Capacity
大体时间:January 1, 2026 to December 31, 2026
Estimation of VO2 max per ml/kg/min derived from results of 3-minute step test
January 1, 2026 to December 31, 2026

次要结果测量

结果测量
措施说明
大体时间
Prediabetes
大体时间:January 1 - December 31 2026
As defined by HbA1c levels
January 1 - December 31 2026
Cardiometabolic Risk
大体时间:January 1 - December 31 2026
As defined by blood pressure
January 1 - December 31 2026
Pediatric Obesity
大体时间:January 1 - December 31 2026
As defined by BMI percentile > 95th percentile
January 1 - December 31 2026
LDL
大体时间:January 1 - December 31 2026
As determined by level of low-density lipoprotein
January 1 - December 31 2026
HDL
大体时间:January 1 - December 31 2026
As defined by high-density lipoprotein levels
January 1 - December 31 2026
Dyslipidemia
大体时间:January 1 - December 31 2026
As defined by levels of Triglycerides
January 1 - December 31 2026
Cholesterolemia
大体时间:January 1 - December 31 2026
As defined by level of total cholesterol
January 1 - December 31 2026
RHR
大体时间:January 1 - December 31 2026
As defined by resting heart rate in beats per minute
January 1 - December 31 2026

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。

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)

2026年8月5日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2027年1月31日

研究注册日期

首次提交

2026年8月18日

首先提交符合 QC 标准的

2026年8月31日

首次发布 (实际的)

2026年9月4日

研究记录更新

最后更新发布 (实际的)

2026年9月4日

上次提交的符合 QC 标准的更新

2026年8月31日

最后验证

2026年8月1日

更多信息

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