AsthmaETANCT00839137
Exercise Therapy for Asthma (ETA Trial)
An observational study of Asthma, run by Ohio State University at 1 site in United States.
Trial summary
The purpose of the study is to determine if a program of regular exercise can help reduce asthma symptoms and also reduce the inflammation caused by asthma. If successful, this would allow regular exercise to be recommended as a therapy for people with asthma, which could possibly reduce the amount of medicine that… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Asthma
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Dec 2009
- Phase
- Observational
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: primary care clinic, community sample
Who may be able to join
- • 18-50 years old
- 50 + years old with prior approval to begin an exercise program from primary care physician within 6 months of enrollment
- Men and women
- Asthma:
- Doctor diagnosed asthma
- Lung function tests must meet certain levels common in asthma patients
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- Active, daily doctor-prescribed asthma controller medication (inhaled corticosteroid) for 2 months or longer at a minimum dose equivalent to fluticasone 88 mcg/day, about two (2) puffs. (you can be on other drugs as long as they are in the same dose range as fluticasone)
- Poor asthma control: Any one of the following conditions:
- Use of beta-agonist (A bronchodilator medicine that opens the airways by relaxing the muscles around the airways that may tighten during an asthma attack )for asthma symptoms twice/week or more OR
- Awakening from sleep with asthma symptoms more than once per week OR
- One or more control problems identified on the Asthma Treatment and Control Questionnaire (ATAQ).
- Smoking status:
- Non-smoker for 6 months or longer
- Less than 10 pack year (number of packs per day (x) years of smoking = pack years) smoking history
Who cannot join
- • Poor lung function
- Current participation in a regular aerobic exercise program (formal or at home)
- Any "yes" to any one of items a-e of question number two of the Stanford Usual Activity Questionnaire
- Pregnancy
- Sudden illness that accompanies fever (> 38.00 C or 100.40F) within 24 hours of Visit 2
- Participation in another interventional research trial Other major chronic illnesses that would interfere with participation in the study
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- Medication use:
- Chronic oral corticosteroid use
- Oral corticosteroid use within 4 weeks of study start
- Anti-coagulants (An anticoagulant is a drug that helps prevent the clotting (coagulation) of blood.), insulin, any investigative drugs within 2 months
- Drug allergy:
- Previous adverse effects from methacholine challenge
- Non-adherence:
- Inability or unwillingness to provide consent
- Inability to perform aerobic exercise
- Inability to perform baseline measurements
- Less than 80% completion of screening period diaries
- Inability to contact by telephone
- Intention to move out of the area within 6 months
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to determine if a program of regular exercise can help reduce asthma symptoms and also reduce the inflammation caused by asthma. If successful, this would allow regular exercise to be recommended as a therapy for people with asthma, which could possibly reduce the amount of medicine that people with asthma need to control their asthma symptoms.
Read the detailed description
This is a randomized, controlled, parallel-design study of the effectiveness of exercise therapy as add-on therapy in the treatment of mild to moderately severe asthma.
105 men and women between the ages of 18-50 years with asthma will be randomly assigned to one of two treatment groups: exercise therapy or control. The exercise therapy protocol is detailed below. The control group will receive usual asthma care. The control group will be instructed to maintain their current sedentary activity level, i.e. not to begin a formal or informal exercise program. In order to standardize contact with study personnel between the two groups the control group will be seen three times a week for clinic visits (exercise group will have sessions three times a week). The primary outcome measures are asthma control (asthma symptom score) and asthma-related inflammation. Secondary outcomes include exacerbation rate, asthma-related quality of life, generic quality of life, lung function, airways hyper-reactivity, and cardiovascular fitness. The effect of exercise therapy on inflammatory markers in blood, and sputum will be assessed by comparing results obtained at study completion versus those obtained at baseline.
- Conditions
- Asthma
- Keywords
- asthma, exercise therapy
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| no exercise program group | group will continue with current level of activity and will be asked not to start an exercise program. They will be seen in the clinic three times a week for 12 weeks. These visits will be very brief; blood pressure, heart rate, oxygen level and peak flow will be measured at each visit | |
| exercise group | will meet three times a week for 12 weeks, following specific exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effectiveness of a behavioral intervention, exercise therapy as a primary therapy for asthma
To determine the effectiveness of a behavioral intervention, exercise therapy as a primary
Measured: end of study
Secondary outcomes (1)
to determine how one program of exercise therapy affects asthma symptoms and inflammatory markers from the blood and the lung of asthmatics
To determine the effectiveness of a behavioral intervention, exercise therapy as a primary
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2009 (estimated)
- Study startDec 2003
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: Study proved difficult to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John G Mastronarde, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00839137
- Sponsor's protocol ID
- 2003H0213
- Acronym
- ETA
- Status last verified
- Nov 2021
- First submitted
- 6 Feb 2009
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Therapy for Asthma (ETA Trial)
- ClinicalTrials.gov ID
- NCT00839137
- Acronym / sponsor ID
- ETA / 2003H0213
- Conditions
- Asthma
- Keywords
- asthma, exercise therapy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study proved difficult to recruit
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Dec 2003
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 9 Feb 2009 (estimated)
- 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.
The purpose of the study is to determine if a program of regular exercise can help reduce asthma symptoms and also reduce the inflammation caused by asthma. If successful, this would allow regular exercise to be recommended as a therapy for people with asthma, which could possibly reduce the amount of medicine that people with asthma need to control their asthma symptoms.
Detailed description
This is a randomized, controlled, parallel-design study of the effectiveness of exercise therapy as add-on therapy in the treatment of mild to moderately severe asthma.
105 men and women between the ages of 18-50 years with asthma will be randomly assigned to one of two treatment groups: exercise therapy or control. The exercise therapy protocol is detailed below. The control group will receive usual asthma care. The control group will be instructed to maintain their current sedentary activity level, i.e. not to begin a formal or informal exercise program. In order to standardize contact with study personnel between the two groups the control group will be seen three times a week for clinic visits (exercise group will have sessions three times a week). The primary outcome measures are asthma control (asthma symptom score) and asthma-related inflammation. Secondary outcomes include exacerbation rate, asthma-related quality of life, generic quality of life, lung function, airways hyper-reactivity, and cardiovascular fitness. The effect of exercise therapy on inflammatory markers in blood, and sputum will be assessed by comparing results obtained at study completion versus those obtained at baseline.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no exercise program group | – | –group will continue with current level of activity and will be asked not to start an exercise program. They will be seen in the clinic three times a week for 12 weeks. These visits will be very brief; blood pressure, heart rate, oxygen level and peak flow will be measured at each visit |
| exercise group | – | –will meet three times a week for 12 weeks, following specific exercise program |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- primary care clinic, community sample
Key inclusion criteria (14 listed)
- • 18-50 years old
- Doctor diagnosed asthma
- Lung function tests must meet certain levels common in asthma patients
- Active, daily doctor-prescribed asthma controller medication (inhaled corticosteroid) for 2 months or longer at a minimum dose equivalent to fluticasone 88 mcg/day, about two (2) puffs. (you can be on other drugs as long as they are in the same dose range as fluticasone)
- Poor asthma control: Any one of the following conditions:
Key exclusion criteria (19 listed)
- • Poor lung function
- Chronic oral corticosteroid use
- Oral corticosteroid use within 4 weeks of study start
- Anti-coagulants (An anticoagulant is a drug that helps prevent the clotting (coagulation) of blood.), insulin, any investigative drugs within 2 months
- Previous adverse effects from methacholine challenge
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the effectiveness of a behavioral intervention, exercise therapy as a primary therapy for asthma
Time frame: end of study
To determine the effectiveness of a behavioral intervention, exercise therapy as a primary
1 secondary outcome
to determine how one program of exercise therapy affects asthma symptoms and inflammatory markers from the blood and the lung of asthmatics
Time frame: end of study
Results and safety
The study was stopped early (reason given: Study proved difficult to recruit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
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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.
John G Mastronarde, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Ohio State University 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 14 inclusion and 19 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: stopped early, as of the sponsor's last update on 8 Nov 2021. 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 was stopped early (reason given: Study proved difficult to recruit). Results are not available in the source record.
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?
To determine the effectiveness of a behavioral intervention, exercise therapy as a primary therapy for asthma (time frame: end of study). 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 8 Nov 2021; AzTrials last refreshed its copy on 5 Nov 2026.