Exercise and Asthma in Obese Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Obesity related biomarkers and other markers of inflammatory responses: Asthma symptoms and asthma control measures: Lung function Fitness levels and physical activity levels:

Official Title
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Effects of Aerobic Exercise on Asthmatic Responses in Obese Adults

Conditions
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Asthma in Overweight Adults

Intervention / Treatment
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* Other: Home-Based Aerobic Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physician diagnosed asthma Currently prescribed a daily controller asthma medication as evidence of mild-moderate persistent asthma Body Mass Index BMI ≥ 30-45 kg/m2 Exclusion Criteria: Individuals who undergo aerobic exercise regularly (3 or more times per week for more than 20 minutes) 6 months prior to the study Participants with very severe obesity (WHO obese class III) - BMI≥ 45 kg/m2 Individuals with other clinically significant major illnesses, such as congenital heart disease, juvenile arthritis, inflammatory bowel disease, cystic fibrosis, or other conditions that would limit participation in the exercise protocol or interfere with study measurements will not be eligible. Uncontrolled hypertension (resting systolic blood pressure > 150mmHg, and/or diastolic blood pressure >90 mmHg despite anti-hypertension medications. Current use of beta blockers Currently pregnant, pregnant during the previous six months, or planning to become pregnant in the next three months as obtained by self-report. Participants who have experienced a clinically significant exacerbation within the past 6 weeks will be excluded. This includes an unscheduled physician visit, emergency room visit, or hospitalization related or use of systemic corticosteroids for asthma. Unable or unwilling to provide consent Unable or unwilling to perform the exercise protocol and provide study measurements, Inability to perform baseline measurements Intend to move out of the area within 3 months from the start of the study Inability to be contacted by telephone

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Control group | |
| Experimental: Home-based Aerobic Exercise<br>Participants will be prescribed weekly exercise goals starting with 75 minutes a week (e.g., 15 minutes per day, 5 days a week) and progressed to 200 minutes a week (e.g., 40 minutes per day, 5 days a week) by week 12. Exercise will consist of participant preference of mobility exercises, most likely walking. Aerobic exercise, similar to a brisk walk, will be recommended as the primary mode of exercise. | Other: Home-Based Aerobic Exercise<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obesity related biomarkers | 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 | change from Visit 1 (baseline) and Visit 2 (end of study - 12 weeks later) | 
| Asthma symptoms | Asthma symptoms will be measured with the Asthma Symptom Utility Index (ASUI) | change from Visit 1 (baseline) and Visit 2 (end of study - 12 weeks later) | 
| Lung function | Lung function will be evaluated via spirometry according to ATS guidelines. | change from Visit 1 (baseline) and Visit 2 (end of study - 12 weeks later) |