NCT00839137

Terminated

Exercise Therapy for Asthma (ETA Trial)

Ohio State University Source

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Other study identifiers

Sponsor study identifier

2003H0213

Study Type

observational

Actual enrollment (reported)

13

Locations

1 country

Sites

1

Timeline

Study Start

December 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2009

Actual (reported)

Study Completion

December 2009

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 13 participants
Study completion date: December 2009
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
December 2003
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
February 6, 2009
Actual (reported)
First Posted
February 9, 2009
Actual (reported)
Primary Completion
December 2009
Actual (reported)
Study Completion
December 2009
Actual (reported)

Last Updated: November 8, 2021
Status Verified: November 2021
Last Update Submitted: November 1, 2021

Conditions

Asthma

Keywords

asthmaexercise 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

Age18 Years - 50 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

Sampling MethodNon-Probability Sample

Study Population

primary care clinic, community sample

You may qualify if:

18-50 years old

Sponsors & Collaborators

Ohio State University
Otherlead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

John G Mastronarde, MD
Ohio State University
PRINCIPAL INVESTIGATOR

Enrollment

13 participants (actual enrollment reported by the registry).

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 2003

Date type not reported

This date has not been verified as actual or estimated.

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Not ApplicableCompleted

+ 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
+4 more criteria

Contact the study team to confirm eligibility.

Primary Completion

December 2009

Actual (reported)

Study Completion

December 2009

Actual (reported)

Last Updated

November 8, 2021

Record last verified: 2021-11

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00839137
Data provider: ClinicalTrials.gov
Source updated: 2021-11-08
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:24:12 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

no exercise program group

exercise group

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations