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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. August 2026 aktualisiert von: 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

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

200

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

    • Virginia
      • Charlottesville, Virginia, Vereinigte Staaten, 22903
        • Rekrutierung
        • UVA Health
        • Kontakt:
        • Kontakt:
        • Hauptermittler:
          • Aaron Meadows, MMed

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Obese Pediatrics with or without Autism Spectrum Disorder

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Pediatrics with Autism Spectrum Disorder
Obese and Prediabetic
Pediatrics without Autism Spectrum Disorder
Obese and Pediatric

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Cardiorespiratory Fitness
Zeitfenster: 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
Zeitfenster: January 1 - December 31 2026
As defined by handgrip test using hand dynamometer in kilograms
January 1 - December 31 2026
Aerobic Capacity
Zeitfenster: 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

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

5. August 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2026

Studienabschluss (Geschätzt)

31. Januar 2027

Studienanmeldedaten

Zuerst eingereicht

18. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

31. August 2026

Zuerst gepostet (Tatsächlich)

4. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

4. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

31. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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