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Exercise Challenge Test in 3-6 Years Old Asthmatic Children

5 marzo 2007 aggiornato da: Sheba Medical Center

Vigorous exercise is known to cause transient bronchoconstriction in school children with asthma, many of whom initially have normal lung function at rest. The presence and extent of this phenomena in early childhood is difficult to recognize, because exercise induced bronchoconstriction (EIB) may not limit the child's performance and the child may fail to notice the symptoms until taking part in organized or competitive sport. Conversely, as children do participate in vigorous activities all day long, severe EIB may provoke a crucial disabling condition in the child.

In school children the exercise challenge test (ECT) is a well standardized test and is used to make a diagnosis of asthma because it is able to discriminate between asthma and other chronic breathing illnesses of childhood and is also used to determine the effectiveness and optimal dosages of medications prescribed to prevent EIB.

The test includes is a controlled run on a motor-driven treadmill followed by scheduled multiple spirometry maneuvers. This procedure was never been tested and may not be suitable for the preschool age.

In this study we assumed that a free-run test which combined with measurements of duplicate spirometry-sets would be the most convenient way to test young children.

The aims of this study are a) to examine the feasibility of a free-run protocol (according to the ATS/ERS recomendations), followed by duplicate spirometry measurements in early childhood.

b) to explore the existence of exercise induced bronchoconstriction in young children (age 3-6 years old) with respiratory symptoms.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Method:

The children are to come in comfortable clothes and running shoes, having consumed no more than a light meal and having had pulmonary medications withdrawn as described above. A parent, a pediatric pulmonary physician and a technician is present throughout the test. Each child undergoes a physical examination to exclude evidence of wheeze, and baseline spirometry was performed. The children are asked to run freely back and forth (without a nose-clip) in a 50m long corridor next to the pulmonary laboratory. The target is to achieve 6 minutes of "free run" to increase hart-rate to 80% in the maximum for at least 4 minutes according to ATS/ERS recommendations for exercise challenge test in older children [1]. An adult (parent/technician/ physician) will run with the child to encourage him/her to continue running. Heart-rate and O2-saturation is monitored continuously throughout the run using a portable mobile pulse-oximeter monitor (Nonin medical, INC, model 2500, Minneapolis, USA).

Spirometry is measured according to the recommendations for preschool children [2], with a commercial ZAN100 Spirometer situated in the pediatric pulmonary laboratory, by a skilled technician. Measurements are performed in the standing position, without nose-clip (for comfort of the child) until two consecutive technically acceptable curves are achieved. After the free-run, spiroetmry is measured in duplicate sets at 1, 3, 5, 10 and 20 minutes post-exercise [1]. The better of the two curves is selected as the representative value at each interval, but differences between the two values of FEV1 has to be <5%. The following signs are monitored by the pulmonologist: wheeze and prolonged expiration on auscultation over the trachea and two zones of both lungs (upper front and lower back). Cough, shortness of breath, or perceived breathlessness within 20 minutes after the run were noted.

Analysis: Technically acceptable spirometry maneuvers are analyzed. Baseline values are first compared to the spirometry values with relation to height derived from the indices in 109 healthy children in our previous study [3].

Following exercise, best spirometry values for each interval are compared to baseline values. Exercise response was defined as the greatest decrease in FEV1 expressed as a percentage of the baseline values. A bronchoconstriction response to exercise is considered as positive when the FEV1 decrease from baseline was greater than 13% [4]. Student's paired t-test is used for comparison of data between each spirometry index and the calculated values for healthy children. A value of p<0.05 was considered significant.

References:

  1. Guidelines for Methacholine and Exercise Challenge Testing 1999. The official statements of the American Thoracic Society, adopted by the ATS board of directors, 1999. Am J Respir Crit. Care Med 2000;161:309-329.
  2. Aurora P, Stocks J, Oliver C, Saunders C, Castle R, Chaziparasidis G, Bush A; London Cystic Fibrosis Collaboration. Quality control for spirometry in preschool children with and without lung disease. Am J Respir Crit Care Med 2004; 169:1152-1159.
  3. Vilozni D, Barak A, Efrati O, Augarten A, Springer C, Yahav Y, Bentur L. The role of computer games in measuring spirometry in healthy and "asthmatic" preschool children. Chest. 2005; 128:1146-115.
  4. Godfrey S, Springer C, Bar-Yishay E, Avital A. Cut-off points defining normal and asthmatic bronchial reactivity to exercise and inhalation challenges in children and young adults. Eur Respir J. 1999; 14:659-66.

Tipo di studio

Osservativo

Iscrizione

100

Contatti e Sedi

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

Luoghi di studio

      • Ramat-Gan, Israele, 52625
        • Pediatric pulmonary unit, The Edmod and Lili Safra children's Hospital, Sheba Medical Center

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

Da 3 anni a 6 anni (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • 3.0-6.9 year-old children referred for exercise challenge test by pediatric physicians.

Exclusion Criteria:

  • presence of other chronic respiratory conditions (e.g. cystic fibrosis, bronchopulmonary dysplasia); oral or inhaled steroids taken during the previous week; bronchodilator taken within 24 hours prior to the test; wheezing at physical examination prior to exercise test, and baseline FEV1< 70 % predicted.

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

Collaboratori e investigatori

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

Investigatori

  • Investigatore principale: Daphna Vilozni, PhD, Sheba Medical Center

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

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

1 ottobre 2006

Completamento dello studio

1 dicembre 2006

Date di iscrizione allo studio

Primo inviato

1 marzo 2007

Primo inviato che soddisfa i criteri di controllo qualità

1 marzo 2007

Primo Inserito (Stima)

2 marzo 2007

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

6 marzo 2007

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 marzo 2007

Ultimo verificato

1 marzo 2007

Maggiori informazioni

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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