Clinical trial NCT03716219: The Effect of 10-Week Exercise Training on Children With Asthma
Official title: Exercise Training in Children and Adults: Mechanisms of Allaying Inflammation in Asthma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Asthma in Children
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 0
Sex: ALL
Minimum age (years): 8
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this research is to determine whether 10-weeks of exercise training can benefit asthmatic children and young adults with a history of exercise-induced bronchoconstriction (EIB). The investigators will also study an exciting newly discovered aspect of gene expression regulation in the white blood cells known as epigenetics: a process that takes place when genomic changes happen as a result of exposure to the environment. This study is based on emerging exciting new data from this and other laboratories demonstrating that (a) white blood cells play an important role in bronchoconstriction in children, (b) gene and cytokine expression in circulating white blood cells are abnormal in asthma and (c) brief exercise may change genomic and inflammatory- profiles of these cells.Physical activity is an essential component of growth and health in children, thus, this research will lead to improved clinical uses of exercise as preventive and adjunctive therapy in the current epidemic of childhood asthma


Eligibility criteria: Inclusion Criteria:

* Good health
* Physical activity
* No evidence of disease or disability
* Diagnosed with persistent asthma (asthma subjects)
* BMI\<95 percentile

Exclusion Criteria:

* Use of illegal drugs or alcohol
* Very high physical fitness
* Pregnancy
* More than two asthma attack per week (asthma subjects)

Primary outcomes:
measure: Gene and microRNA expression will be compared between healthy and asthmatic subjects
timeFrame: 12 weeks
Secondary outcomes:
measure: Pro/anti-inflammatory cytokines and markers of oxidative stress will be compared between the groups
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Pediatric Exercise and Genomics Research Center, University of California, Irvine
state: California
Study officials:
References:
citation: Drews AC, Pizzichini MM, Pizzichini E, Pereira MU, Pitrez PM, Jones MH, Sly PD, Stein RT. Neutrophilic airway inflammation is a main feature of induced sputum in nonatopic asthmatic children. Allergy. 2009 Nov;64(11):1597-601. doi: 10.1111/j.1398-9995.2009.02057.x. Epub 2009 Apr 14.
citation: Dougherty RH, Fahy JV. Acute exacerbations of asthma: epidemiology, biology and the exacerbation-prone phenotype. Clin Exp Allergy. 2009 Feb;39(2):193-202. doi: 10.1111/j.1365-2222.2008.03157.x.
citation: Baines KJ, Simpson JL, Scott RJ, Gibson PG. Immune responses of airway neutrophils are impaired in asthma. Exp Lung Res. 2009 Sep;35(7):554-69. doi: 10.1080/01902140902777490.
citation: Baines KJ, Simpson JL, Bowden NA, Scott RJ, Gibson PG. Differential gene expression and cytokine production from neutrophils in asthma phenotypes. Eur Respir J. 2010 Mar;35(3):522-31. doi: 10.1183/09031936.00027409. Epub 2009 Sep 24.
citation: Radom-Aizik S, Zaldivar F Jr, Oliver S, Galassetti P, Cooper DM. Evidence for microRNA involvement in exercise-associated neutrophil gene expression changes. J Appl Physiol (1985). 2010 Jul;109(1):252-61. doi: 10.1152/japplphysiol.01291.2009. Epub 2010 Jan 28.
citation: Cooper DM, Radom-Aizik S, Schwindt C, Zaldivar F Jr. Dangerous exercise: lessons learned from dysregulated inflammatory responses to physical activity. J Appl Physiol (1985). 2007 Aug;103(2):700-9. doi: 10.1152/japplphysiol.00225.2007. Epub 2007 May 10.
citation: Petersen AM, Pedersen BK. The role of IL-6 in mediating the anti-inflammatory effects of exercise. J Physiol Pharmacol. 2006 Nov;57 Suppl 10:43-51.