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Exercise and Asthma in Obese Adults

Primary Purpose

Asthma in Overweight Adults

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home-Based Aerobic Exercise
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma in Overweight Adults

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Arizona and the Tucson Unified School District

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Home-based Aerobic Exercise

Arm Description

Control group

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.

Outcomes

Primary Outcome Measures

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
Asthma symptoms
Asthma symptoms will be measured with the Asthma Symptom Utility Index (ASUI)
Lung function
Lung function will be evaluated via spirometry according to ATS guidelines.

Secondary Outcome Measures

Full Information

First Posted
May 1, 2017
Last Updated
October 13, 2017
Sponsor
University of Arizona
Collaborators
Arizona Biomedical Research Commission (ABRC)
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1. Study Identification

Unique Protocol Identification Number
NCT03145883
Brief Title
Exercise and Asthma in Obese Adults
Official Title
Effects of Aerobic Exercise on Asthmatic Responses in Obese Adults
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
July 1, 2015 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
Collaborators
Arizona Biomedical Research Commission (ABRC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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:

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Overweight Adults

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group
Arm Title
Home-based Aerobic Exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Home-Based Aerobic Exercise
Primary Outcome Measure Information:
Title
Obesity related biomarkers
Description
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
Time Frame
change from Visit 1 (baseline) and Visit 2 (end of study - 12 weeks later)
Title
Asthma symptoms
Description
Asthma symptoms will be measured with the Asthma Symptom Utility Index (ASUI)
Time Frame
change from Visit 1 (baseline) and Visit 2 (end of study - 12 weeks later)
Title
Lung function
Description
Lung function will be evaluated via spirometry according to ATS guidelines.
Time Frame
change from Visit 1 (baseline) and Visit 2 (end of study - 12 weeks later)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chrstian Bime, MD
Organizational Affiliation
University of Arizona, College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Arizona and the Tucson Unified School District
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Exercise and Asthma in Obese Adults

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