Exercise Therapy for Asthma (ETA Trial)
Exercise Therapy for Asthma (ETA Trial)
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.
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.
Inclusion Criteria:

 -  • 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 Criteria:

 -  • 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