Clinical trial NCT03145883: Exercise and Asthma in Obese Adults
Official title: Effects of Aerobic Exercise on Asthmatic Responses in Obese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma in Overweight Adults
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: Arizona Biomedical Research Commission (ABRC)
First posted: 2017-05-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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: 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:

Eligibility criteria: 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

Primary outcomes:
measure: Obesity related biomarkers
timeFrame: change from Visit 1 (baseline) and Visit 2 (end of study - 12 weeks later)
measure: Asthma symptoms
timeFrame: change from Visit 1 (baseline) and Visit 2 (end of study - 12 weeks later)
measure: Lung function
timeFrame: change from Visit 1 (baseline) and Visit 2 (end of study - 12 weeks later)
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: The University of Arizona and the Tucson Unified School District
state: Arizona
Study officials:
affiliation: University of Arizona, College of Medicine
name: Chrstian Bime, MD
role: PRINCIPAL_INVESTIGATOR
References: