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IUGR, Respiratory Muscle Function, and Exercise Capacity in Childhood

27. April 2021 aktualisiert von: Fouzas Sotirios, University of Patras

Effect of Intrauterine Growth Restriction on Respiratory Muscle Function and Exercise Tolerance in Childhood

The study hypothesis is that intrauterine growth restriction (IUGR) may have long-term effects on respiratory muscle (RM) function, thus leading to reduced exercise capacity later in life. The objective is to investigate the above hypothesis by comparing RM function and cardiopulmonary exercise testing (CPET) parameters between school-aged children exposed to IUGR and healthy controls.

Studienübersicht

Detaillierte Beschreibung

Introduction

Epidemiological evidence supports the existence of a link between intrauterine growth restriction (IUGR) and reduced exercise capacity in young adulthood. Prolonged intrauterine hypoxia results in redistribution of fetal cardiac output towards the vital organs at the expense of skeletal muscles, and experimental data show that the muscles of animals exposed to IUGR may suffer permanent structural and functional changes. Prematurity, which often accompanies IUGR, is also associated with reduced exercise capacity later in life, supposedly due to airflow limitation, air trapping and/or reduced gas-exchange capacity.

The respiratory muscles (RM) play a central role in the development (and perception) of locomotor muscle fatigue, which represents the major determinant of exercise limitation in otherwise healthy subjects. Heavy and/or sustained respiratory work leads to accumulation of metabolites in RM and triggers reflexes that increase the sympathetic vasoconstrictor outflow to the skeletal muscles, thus promoting fatigue. In support of the above concept, targeted RM training has been shown to increase the fatigability threshold and improve exercise performance.

RM function can be assessed by means of strength and endurance, which can be estimated non-invasively by the maximum inspiratory and expiratory pressure (Pimax and Pemax), and the tension-time index (TTImus), respectively. TTImus is a composite parameter that reflects the balance between the capacity of RM and the load imposed upon them; high TTImus values indicate low endurance and increased risk of respiratory fatigue. In adults, impaired exercise tolerance is associated with reduced RM strength and endurance, both in normal and pathological conditions. However, similar data are not available in children.

Hypothesis and objectives

The study hypothesis is that IUGR may have long-term effects on RM function, thus leading to reduced exercise capacity later in life. Other factors, such as the presence and degree of respiratory dysfunction, the performance of the skeletal muscles and the nutritional status, may also be involved. The study objective is to investigate the above hypothesis by comparing RM function and cardiopulmonary exercise testing (CPET) parameters between school-aged children exposed to IUGR and healthy controls, taking also into account the aforementioned confounders.

Methods

Population

In this case-control study, 50 school-aged children (7-10 years old) exposed to IUGR (birth weight <10th percentile & fetal ultrasound documentation) will be compared with 100 matched for age and gestational age controls. The study will be performed in the Pediatric CPET laboratory of the University Hospital of Patras, Greece, during a 2-year period (2018-2020). Participants will be recruited from the long-term follow-up program offered to all children who are born preterm or with IUGR, and from the local schools (healthy full-term controls). The protocol will be approved by the hospital Ethics Committee and parental informed consent will be obtained prior to enrollment.

Protocol

After a thorough review of the medical history, participants will undergo the following tests:

  1. Nutritional status, body composition and skeletal muscle strength. Initially, weight and height will be measured, and the body mass index (BMI) will be calculated. Body composition (muscular mass, body fat, water) will be determined by the InBody 270 Body Composition Analyzer (Biospace, Seoul, Korea) using bioelectrical impedance analysis. Skeletal muscle strength (grasping power) will be measured using a digital grip dynamometer (Grip-D, TAKEI, Japan).
  2. Lung function measurements. Spirometry, measurement of lung volumes (helium dilution technique) and measurement of lung diffusion capacity for carbon monoxide (DLCO) will be performed prior to CPET using the Jaeger MasterScreen PFT device (CareFusion, San Diego, USA). Spirometric measurements will be repeated at 5, 10, and 15 minutes after CPET.
  3. RM function. Pimax, Pemax, airway pressure at 100 msec after occlusion (P0.1), and Ti and Ttot will be measured by the Micro 5000 device (Medisoft, Sorinnes, Belgium) according to the guidelines. TTImus will be calculated as (Pimean / Pimax) x (Ti / Ttot), where Pimean is the mean airway pressure resulting from the formula Pimean = 5 x P0.1 x Ti. RM function will be determined a) prior to CPET, b) during CPET when the anaerobic threshold (AT) will be reached, and c) after CPET, when heart rate (HR) and oxygen consumption will be normalized (recovery period).
  4. CPET. CPET will be performed by the Ultima CPX system (Medgraphics, St. Paul, USA), using a cycle ergometer and according to a standardized protocol11 and the established guidelines. The following parameters will be recorded: total work in Watts, maximum HR, maximum oxygen consumption (VO2max), AT indices (work, HR, VO2 ) and duration of recovery.

Statistical analysis

Between-group comparisons will be performed with Student's t or Mann-Whitney U test, as appropriate. Linear regression analysis will be used to explore the relationship between RM function and CPET parameters, after adjustment for nutritional status, body composition, lung function, and prematurity. The trend of Pimax, Pemax, and TTImus changes during CPET (baseline - AT - recovery) will be also assessed and compared between groups. The analyses will be performed using the IBM SPSS version 23.0 (IBM Corp., Armonk, NY).

Innovation and implications

The study will be the first to explore whether IUGR is associated with impaired exercise tolerance in childhood due to RM dysfunction, while taking into account the confounding effect of prematurity, impaired lung function, body composition and nutritional status.

Should the relationship IUGR - RM dysfunction - exercise limitation be confirmed, it will provide new insights on the long-term effects of IUGR; impaired exercise tolerance may lead to reduced physical activity, thus enhancing the well-known metabolic and cardiovascular consequences of IUGR later in life. In this regard, the findings of this study may assist in identifying children at risk and planning targeted strategies to improve exercise capacity in this vulnerable population.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

150

Phase

  • Unzutreffend

Kontakte und Standorte

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

Studienkontakt

Studienorte

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

7 Jahre bis 10 Jahre (Kind)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • (Cases) School-aged children (7-10 years old) exposed to IUGR (birth weight <10th percentile & fetal ultrasound documentation)
  • (Controls) School-aged children (7-10 years old) NOT exposed to IUGR (birth weight >10th percentile)

Exclusion Criteria:

  • Disability
  • Congenital heart disease
  • Current (active) respiratory infection

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Diagnose
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Cases (IUGR)
50 school-aged children (7-10 years old) exposed to IUGR (birth weight <10th percentile & fetal ultrasound documentation) and of comparable gestational age with controls Intervention: Cardiopulmonary Exercise Testing and Respiratory Muscle Strength and Endurance
Pimax, Pemax, airway pressure at 100 msec after occlusion (P0.1), and Ti and Ttot will be measured by the Micro 5000 device (Medisoft, Sorinnes, Belgium). TTImus will be calculated as (Pimean / Pimax) x (Ti / Ttot), where Pimean is the mean airway pressure resulting from the formula Pimean = 5 x P0.1 x Ti9. RM function will be determined a) prior to CPET, b) during CPET when the anaerobic threshold (AT) will be reached, and c) after CPET, when heart rate (HR) and oxygen consumption will be normalized.
CPET will be performed by the Ultima CPX system (Medgraphics, St. Paul, USA), using a cycle ergometer and according to a standardized protocol. The following parameters will be recorded: total work in Watts, maximum HR, maximum oxygen consumption (VO2max), AT indices (work, HR, VO2 ) and duration of recovery.
Aktiver Komparator: Controls

100 school-aged children (7-10 years old) not exposed to IUGR (birth weight <10th percentile & fetal ultrasound documentation) and of comparable gestational age with cases.

Intervention: Cardiopulmonary Exercise Testing and Respiratory Muscle Strength and Endurance

Pimax, Pemax, airway pressure at 100 msec after occlusion (P0.1), and Ti and Ttot will be measured by the Micro 5000 device (Medisoft, Sorinnes, Belgium). TTImus will be calculated as (Pimean / Pimax) x (Ti / Ttot), where Pimean is the mean airway pressure resulting from the formula Pimean = 5 x P0.1 x Ti9. RM function will be determined a) prior to CPET, b) during CPET when the anaerobic threshold (AT) will be reached, and c) after CPET, when heart rate (HR) and oxygen consumption will be normalized.
CPET will be performed by the Ultima CPX system (Medgraphics, St. Paul, USA), using a cycle ergometer and according to a standardized protocol. The following parameters will be recorded: total work in Watts, maximum HR, maximum oxygen consumption (VO2max), AT indices (work, HR, VO2 ) and duration of recovery.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
VO2 max
Zeitfenster: 1 day (during exercise testing)
Maximum O2 consumption, in ml/kg/min. The index will be compared between IUGR and controls.
1 day (during exercise testing)
TTmus
Zeitfenster: 1 day (during exercise testing)
Tension-time index of the respiratory muscles. No values (ratio). The index will be compared between IUGR and controls.
1 day (during exercise testing)

Mitarbeiter und Ermittler

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

Ermittler

  • Hauptermittler: Sotirios Fouzas, MD, PhD, University of Patras, Greece
  • Studienstuhl: Gabriel Dimitriou, MD, PhD, University of Patras, Greece

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)

8. Januar 2018

Primärer Abschluss (Voraussichtlich)

31. Dezember 2021

Studienabschluss (Voraussichtlich)

30. Januar 2022

Studienanmeldedaten

Zuerst eingereicht

24. November 2017

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. Dezember 2017

Zuerst gepostet (Tatsächlich)

11. Dezember 2017

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

28. April 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. April 2021

Zuletzt verifiziert

1. April 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

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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