NCT03716219

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2013

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 23, 2018

Completed
Last Updated

February 12, 2021

Status Verified

February 1, 2021

Enrollment Period

Same day

First QC Date

October 3, 2018

Last Update Submit

February 9, 2021

Conditions

Outcome Measures

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

    12 weeks

Secondary Outcomes (1)

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

    12 weeks

Study Arms (2)

Healthy Subjects

OTHER

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

Other: Exercise Training

Subjects with Asthma

EXPERIMENTAL

Subjects with asthma who received exercise training

Other: Exercise Training

Interventions

Physical activity in children and adults with asthma.

Healthy SubjectsSubjects with Asthma

Eligibility Criteria

Age8 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Exercise and Genomics Research Center, University of California, Irvine

Irvine, California, 92697/92617, United States

Location

Related Publications (7)

  • 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.

    PMID: 19392986BACKGROUND
  • 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.

    PMID: 19187331BACKGROUND
  • 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.

    PMID: 19842845BACKGROUND
  • 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.

    PMID: 19797135BACKGROUND
  • 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.

    PMID: 20110541BACKGROUND
  • 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.

    PMID: 17495117BACKGROUND
  • 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.

    PMID: 17242490BACKGROUND

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2018

First Posted

October 23, 2018

Study Start

October 10, 2013

Primary Completion

October 10, 2013

Study Completion

October 10, 2013

Last Updated

February 12, 2021

Record last verified: 2021-02

Locations