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IUGR, Respiratory Muscle Function, and Exercise Capacity in Childhood

27 april 2021 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Verwacht)

150

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

7 jaar tot 10 jaar (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Actieve vergelijker: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
VO2 max
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Sotirios Fouzas, MD, PhD, University of Patras, Greece
  • Studie stoel: Gabriel Dimitriou, MD, PhD, University of Patras, Greece

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

8 januari 2018

Primaire voltooiing (Verwacht)

31 december 2021

Studie voltooiing (Verwacht)

30 januari 2022

Studieregistratiedata

Eerst ingediend

24 november 2017

Eerst ingediend dat voldeed aan de QC-criteria

5 december 2017

Eerst geplaatst (Werkelijk)

11 december 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 april 2021

Laatste update ingediend die voldeed aan QC-criteria

27 april 2021

Laatst geverifieerd

1 april 2021

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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