- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03716219
The Effect of 10-Week Exercise Training on Children With Asthma
February 9, 2021 updated by: University of California, Irvine
Exercise Training in Children and Adults: Mechanisms of Allaying Inflammation in Asthma
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
Study Overview
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Irvine, California, United States, 92697/92617
- Pediatric Exercise and Genomics Research Center, University of California, Irvine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 35 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Healthy Subjects
Healthy control group which received the same exercise training intervention as the experimental group
|
Physical activity in children and adults with asthma.
|
Experimental: Subjects with Asthma
Subjects with asthma who received exercise training
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Physical activity in children and adults with asthma.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gene and microRNA expression will be compared between healthy and asthmatic subjects
Time Frame: 12 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pro/anti-inflammatory cytokines and markers of oxidative stress will be compared between the groups
Time Frame: 12 weeks
|
Absolute values of cytokines, growth hormones, and other biomarkers will be measured by flow cytometry and statistically analyzed.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 10, 2013
Primary Completion (Actual)
October 10, 2013
Study Completion (Actual)
October 10, 2013
Study Registration Dates
First Submitted
October 3, 2018
First Submitted That Met QC Criteria
October 19, 2018
First Posted (Actual)
October 23, 2018
Study Record Updates
Last Update Posted (Actual)
February 12, 2021
Last Update Submitted That Met QC Criteria
February 9, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-9253
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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