Exercise and Asthma in Obese Adults

Effects of Aerobic Exercise on Asthmatic Responses in Obese Adults

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.

Study Overview

• Status: Completed
• Conditions: Asthma in Overweight Adults
• Intervention / Treatment: Other: Home-Based Aerobic Exercise

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:

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • The University of Arizona and the Tucson Unified School District

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Home-based Aerobic Exercise; 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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Arizona
• Collaborators: Arizona Biomedical Research Commission (ABRC)
• Investigators: Principal Investigator: Chrstian Bime, MD, University of Arizona, College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: May 1, 2017
• First Submitted That Met QC Criteria: May 8, 2017
• First Posted (Actual): May 9, 2017

Study Record Updates

• Last Update Posted (Actual): October 16, 2017
• Last Update Submitted That Met QC Criteria: October 13, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Body Weight; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Overweight
• Other Study ID Numbers: 1504818055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No