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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)

31 agosto 2026 aggiornato da: 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

Panoramica dello studio

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Stimato)

200

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • Virginia
      • Charlottesville, Virginia, Stati Uniti, 22903
        • Reclutamento
        • UVA Health
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Aaron Meadows, MMed

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Obese Pediatrics with or without Autism Spectrum Disorder

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Cardiorespiratory Fitness
Lasso di tempo: 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
Lasso di tempo: January 1 - December 31 2026
As defined by handgrip test using hand dynamometer in kilograms
January 1 - December 31 2026
Aerobic Capacity
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Prediabetes
Lasso di tempo: January 1 - December 31 2026
As defined by HbA1c levels
January 1 - December 31 2026
Cardiometabolic Risk
Lasso di tempo: January 1 - December 31 2026
As defined by blood pressure
January 1 - December 31 2026
Pediatric Obesity
Lasso di tempo: January 1 - December 31 2026
As defined by BMI percentile > 95th percentile
January 1 - December 31 2026
LDL
Lasso di tempo: January 1 - December 31 2026
As determined by level of low-density lipoprotein
January 1 - December 31 2026
HDL
Lasso di tempo: January 1 - December 31 2026
As defined by high-density lipoprotein levels
January 1 - December 31 2026
Dyslipidemia
Lasso di tempo: January 1 - December 31 2026
As defined by levels of Triglycerides
January 1 - December 31 2026
Cholesterolemia
Lasso di tempo: January 1 - December 31 2026
As defined by level of total cholesterol
January 1 - December 31 2026
RHR
Lasso di tempo: January 1 - December 31 2026
As defined by resting heart rate in beats per minute
January 1 - December 31 2026

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

5 agosto 2026

Completamento primario (Stimato)

31 dicembre 2026

Completamento dello studio (Stimato)

31 gennaio 2027

Date di iscrizione allo studio

Primo inviato

18 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

31 agosto 2026

Primo Inserito (Effettivo)

4 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

31 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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