Exercise and Asthma in Obese Adults

NCT03145883 | Completed

• 1 other identifier: 1504818055
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma in Overweight Adults

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (2)

Control group

NO INTERVENTION

Control group

Home-based Aerobic Exercise

EXPERIMENTAL

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

Interventions

Home-Based Aerobic Exercise OTHER

Home-based Aerobic Exercise

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead
• Arizona Biomedical Research Commission (ABRC): collaborator

Study Sites (1)

The University of Arizona and the Tucson Unified School District

Tucson, Arizona, 85724, United States

Location

Study Officials

• Chrstian Bime, MD

  University of Arizona, College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 9, 2017
• Study Start: July 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 16, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)