Asthma in Overweight Adults Clinical Trial
Official title:
Effects of Aerobic Exercise on Asthmatic Responses in Obese Adults
| Verified date | April 2017 |
| Source | University of Arizona |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | September 2017 |
| Est. primary completion date | September 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 55 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | The University of Arizona and the Tucson Unified School District | Tucson | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| University of Arizona | Arizona Biomedical Research Commission (ABRC) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | |
| Primary | 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) | |
| Primary | 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) |