Exercise Therapy for Asthma (ETA Trial)

NCT00839137 | Terminated

• 1 other identifier: 2003H0213
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Asthma

Keywords

asthma; exercise therapy

Outcome Measures

Primary Outcomes (1)

• 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

  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

  end of study

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic, community sample

You may qualify if:

• 18-50 years old
• + 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• John G Mastronarde, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2009
• First Posted: February 9, 2009
• Study Start: December 1, 2003
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 8, 2021

Record last verified: 2021-11

Locations

US (1)