The University of Arizona and the Tucson Unified School District
Tucson, Arizona, 85724, United States
NCT Number: NCT03145883
This pilot study will use an unmasked, parallel group, randomized design. Thirty adult overweight or obese subjects with mild-moderate persistent asthma will be randomly assigned to one of two groups: 12-weeks of home-based moderate intensity aerobic exercise versus no intervention. The study will include 2 clinic visits and 12 telephone calls. Exercise testing to assess physical fitness levels will occur during visits 1 and 2. Blood sampling for biomarkers, inflammatory markers, and other assessments will be done.
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Notify Me18 year–55 year
All sexes
Interventional
Not applicable
Tucson, Arizona, 85724, United States
The primary aim of this pilot study is to recruit and retain obese adults with mild-moderate persistent asthma for a study protocol that includes exercise at a moderate intensity level in a home-based setting. The investigators primary hypothesis is that compared to no intervention, 12-weeks of moderate intensity aerobic exercise will attenuate serum levels of adipokines (leptin, adiponectin), and other pro-inflammatory markers. The investigators will also analyze the effect of the intervention on fitness levels, pulmonary function, asthma symptoms, asthma control, and asthma-related quality of life.
Given that this is a proof of concept/feasibility study, there is no primary outcome measure. The following measures will be assessed:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: change from Visit 1 (baseline) and Visit 2 (end of study - 12 weeks later)
Obesity markers will be evaluated in peripheral blood: Leptin and adiponectin, two adipokines that have been previously implicated in the link between asthma and obesity will be measured in peripheral blood via ELISA
Time frame: change from Visit 1 (baseline) and Visit 2 (end of study - 12 weeks later)
Asthma symptoms will be measured with the Asthma Symptom Utility Index (ASUI)
Time frame: change from Visit 1 (baseline) and Visit 2 (end of study - 12 weeks later)
Lung function will be evaluated via spirometry according to ATS guidelines.
University of Arizona
Other
Effects of Aerobic Exercise on Asthmatic Responses in Obese Adults
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.