Status:
TERMINATED
Exercise Therapy for Asthma (ETA Trial)
Lead Sponsor:
Ohio State University
Conditions:
Asthma
Eligibility:
All Genders
18-50 years
Brief 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 exe...
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 ...
Eligibility Criteria
Inclusion
- • 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
- 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
Exclusion
- • 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
- 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
Key Trial Info
Start Date :
December 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00839137
Start Date
December 1 2003
End Date
December 1 2009
Last Update
November 8 2021
Active Locations (1)
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1
The Ohio State University
Columbus, Ohio, United States, 43210