Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

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)

31 de agosto de 2026 atualizado por: 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

Visão geral do estudo

Status

Recrutamento

Condições

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Estimado)

200

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

    • Virginia
      • Charlottesville, Virginia, Estados Unidos, 22903
        • Recrutamento
        • UVA Health
        • Contato:
        • Contato:
        • Investigador principal:
          • Aaron Meadows, MMed

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

Obese Pediatrics with or without Autism Spectrum Disorder

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Pediatrics with Autism Spectrum Disorder
Obese and Prediabetic
Pediatrics without Autism Spectrum Disorder
Obese and Pediatric

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Cardiorespiratory Fitness
Prazo: 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
Prazo: January 1 - December 31 2026
As defined by handgrip test using hand dynamometer in kilograms
January 1 - December 31 2026
Aerobic Capacity
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Prediabetes
Prazo: January 1 - December 31 2026
As defined by HbA1c levels
January 1 - December 31 2026
Cardiometabolic Risk
Prazo: January 1 - December 31 2026
As defined by blood pressure
January 1 - December 31 2026
Pediatric Obesity
Prazo: January 1 - December 31 2026
As defined by BMI percentile > 95th percentile
January 1 - December 31 2026
LDL
Prazo: January 1 - December 31 2026
As determined by level of low-density lipoprotein
January 1 - December 31 2026
HDL
Prazo: January 1 - December 31 2026
As defined by high-density lipoprotein levels
January 1 - December 31 2026
Dyslipidemia
Prazo: January 1 - December 31 2026
As defined by levels of Triglycerides
January 1 - December 31 2026
Cholesterolemia
Prazo: January 1 - December 31 2026
As defined by level of total cholesterol
January 1 - December 31 2026
RHR
Prazo: January 1 - December 31 2026
As defined by resting heart rate in beats per minute
January 1 - December 31 2026

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

5 de agosto de 2026

Conclusão Primária (Estimado)

31 de dezembro de 2026

Conclusão do estudo (Estimado)

31 de janeiro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

18 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

31 de agosto de 2026

Primeira postagem (Real)

4 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

31 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 303916

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .