Asthma in Overweight AdultsNCT03145883
Exercise and Asthma in Obese Adults
A study testing Home-Based Aerobic Exercise in people with Asthma in Overweight Adults, run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Asthma in Overweight Adults
- What is being tested?
- Home-Based Aerobic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2015to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Arizona and the Tucson Unified School District
Tucson, Arizona, 85724
About this study
Official title: 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.
Read the 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:
- Conditions
- Asthma in Overweight Adults
- Being tested
- Home-Based Aerobic Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-Based Aerobic ExerciseOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Home-Based Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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.
Measured: change from Visit 1 (baseline) and Visit 2 (end of study - 12 weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start1 Jul 2015
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in Overweight AdultsStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona Biomedical Research Commission (ABRC)
- Responsible party
- Sponsor
- Investigators
- Chrstian Bime, MD, Principal investigator, University of Arizona, College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03145883
- Sponsor's protocol ID
- 1504818055
- Status last verified
- Apr 2017
- First submitted
- 1 May 2017
- Last updated
- 16 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Exercise on Asthmatic Responses in Obese Adults
- ClinicalTrials.gov ID
- NCT03145883
- Acronym / sponsor ID
- 1504818055
- Conditions
- Asthma in Overweight Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Arizona Biomedical Research Commission (ABRC)
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 9 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Control group |
| Home-based Aerobic Exercise | Experimental | Other: Home-Based Aerobic ExerciseParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-Based Aerobic Exercise | Other | Home-based Aerobic Exercise |
Primary outcome
Obesity related biomarkers
Time frame: change from Visit 1 (baseline) and Visit 2 (end of study - 12 weeks later)
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
Time frame: change from Visit 1 (baseline) and Visit 2 (end of study - 12 weeks later)
Asthma symptoms will be measured with the Asthma Symptom Utility Index (ASUI)
Lung function
Time frame: change from Visit 1 (baseline) and Visit 2 (end of study - 12 weeks later)
Lung function will be evaluated via spirometry according to ATS guidelines.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2017.
- Individual participant dataSharing planned: No
Related trials for Asthma in Overweight Adults
Active, not recruitingPhase 2
Glucagon-Like Peptide-1 Receptor Agonist in the Treatment of Adult, Obesity-related, Symptomatic Asthma (GATA-3)
Asthma
Recruiting
DASH-Obesity: Explainable AI for Family-Centric Personalized Weight Control in Adolescents and Young Adults With Obesity and Chronic Conditions
Type 1 Diabetes, T1D
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chrstian Bime, MD principal investigator
University of Arizona, College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-Based Aerobic Exercise in people with Asthma in Overweight Adults, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obesity related biomarkers (time frame: change from Visit 1 (baseline) and Visit 2 (end of study - 12 weeks later)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2017.