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WithdrawnNCT03716219Updated Feb 12, 2021

The Effect of 10-Week Exercise Training on Children With Asthma

An interventional study of Exercise Training in Asthma in Children, sponsored by University of California, Irvine. Withdrawn at 1 site in United States. Open to participants aged 8 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-12.

Sponsored by University of California, Irvine · Not applicable, Interventional, and Prevention

Why this study was withdrawn
Nonapplicable clinical trial

From the registry’s dates

  • Registered 4 years 11 months after the study started (first participant enrolled Oct 2013, registered Oct 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
8 Years to 35 Years
Sex
All
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Study 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

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Conditions studied

  • Asthma in Children

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03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

Browse Asthma studies →

Lead sponsor

University of California, Irvine is the lead sponsor of 466 studies on the registry; 96 are open to participants now.

Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
8 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Other
    Healthy Subjects

    Healthy control group which received the same exercise training intervention as the experimental group

    Other: Exercise Training

  • Experimental
    Subjects with Asthma

    Subjects with asthma who received exercise training

    Other: Exercise Training

Interventions

  • OtherExercise Training

    Physical activity in children and adults with asthma.

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What researchers measure

Primary outcomes

  1. Gene and microRNA expression will be compared between healthy and asthmatic subjects

    Monocyte gene expression profiling before and after acute bout of exercise before and after 10-week exercise intervention is gauged using RNA seq in a group of children with asthma and age and sex match healthy controls

    Time frame: 12 weeks

Secondary outcomes

  1. Pro/anti-inflammatory cytokines and markers of oxidative stress will be compared between the groups

    Absolute values of cytokines, growth hormones, and other biomarkers will be measured by flow cytometry and statistically analyzed.

    Time frame: 12 weeks

07

Study locations

1 site
  • Pediatric Exercise and Genomics Research Center, University of California, Irvine
    Irvine, California 92697/92617, United States
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References and documents

Publications

  • 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. PubMed 19392986 ↗
  • 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. PubMed 19187331 ↗
  • 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. PubMed 19842845 ↗
  • 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. PubMed 19797135 ↗
  • 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. PubMed 20110541 ↗
  • 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. PubMed 17495117 ↗
  • 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. PubMed 17242490 ↗

Study documents

  • Study protocol · Oct 6, 2017

Documents are hosted by the registry — open the source record to download them.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03716219
Lead sponsor
University of California, Irvine
Responsible party
Sponsor
First posted
Oct 23, 2018
Start date
Oct 10, 2013
Primary completion
Oct 10, 2013
Completion
Oct 10, 2013
Last update
Feb 12, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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