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

Primary Purpose

Asthma in Children

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Training
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma in Children

Eligibility Criteria

8 Years - 35 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Healthy Subjects

Subjects with Asthma

Arm Description

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

Subjects with asthma who received exercise training

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
October 3, 2018
Last Updated
February 9, 2021
Sponsor
University of California, Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT03716219
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Nonapplicable clinical trial
Study Start Date
October 10, 2013 (Actual)
Primary Completion Date
October 10, 2013 (Actual)
Study Completion Date
October 10, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Irvine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Subjects
Arm Type
Other
Arm Description
Healthy control group which received the same exercise training intervention as the experimental group
Arm Title
Subjects with Asthma
Arm Type
Experimental
Arm Description
Subjects with asthma who received exercise training
Intervention Type
Other
Intervention Name(s)
Exercise Training
Intervention Description
Physical activity in children and adults with asthma.
Primary Outcome Measure Information:
Title
Gene and microRNA expression will be compared between healthy and asthmatic subjects
Description
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 Outcome Measure Information:
Title
Pro/anti-inflammatory cytokines and markers of oxidative stress will be compared between the groups
Description
Absolute values of cytokines, growth hormones, and other biomarkers will be measured by flow cytometry and statistically analyzed.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Facility Information:
Facility Name
Pediatric Exercise and Genomics Research Center, University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697/92617
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19392986
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.
Results Reference
background
PubMed Identifier
19187331
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.
Results Reference
background
PubMed Identifier
19842845
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.
Results Reference
background
PubMed Identifier
19797135
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.
Results Reference
background
PubMed Identifier
20110541
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.
Results Reference
background
PubMed Identifier
17495117
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.
Results Reference
background
PubMed Identifier
17242490
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.
Results Reference
background

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

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