Exercise-induced Bronchoconstriction Diagnostics: Impact of a Repeated Exercise Challenge Test

The purpose of this study is to increase the knowledge of the possible diagnostic effect of exercise induced bronchoconstriction performing a repeated exercise challenge test.

Study Overview

Status

Completed

Detailed Description

Prior studies have shown that the intensity influences the sensitivity of exercise challenge tests (ECT) and that a heart rate-based protocol does not ensure sufficient exercise intensity to induce bronchoconstriction. It is not common clinical practice to perform a pre ECT to establish maximal heart rate or maximal oxygen uptake. The heart rate formula recommended by ATS (HRmax= 220-age) is usually applied to determine recommended intensity of the ECT. Conducting a second ECT, based on the knowledge of the first test, introduce the possibility to adjust the intensity on an individual basis. In addition, based on clinical experience, patients may seem reluctant to perform maximal the first time they undergo an ECT on a treadmill. The hypothesis is that patients are less reluctant to perform maximal the second time they undergo the test when they are more accustomed to the procedure and the treadmill by itself.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ullevål
      • Oslo, Ullevål, Norway, 0855
        • Klinikk for allergi og luftveissykdommer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 45 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects referred to Klinikk for allergi og luftveissykdommer

Description

Inclusion Criteria:

  • Referred to Klinikk for allergi og luftveissykdommer
  • Meet at least 3 out of 5 criteria (symptoms related to exercise):

    1. Cough during exercise or within 5 minutes after exercise
    2. Wheeze during exercise or within 5 minutes after exercise
    3. Heavy breathing, expiratory in particular, during exercise or within 5 minutes after exercise (duration 5 minutes or more)
    4. Improvement of physical fitness/breath is lacking despite of exercise intensification
    5. Chest tightness during or after exercise
  • Patients former diagnosed with-and treated for asthma who have symptoms of EIB are included in the study.

Exclusion Criteria:

  • Ongoing respiratory infection or recent respiratory infection, judged by the responsible doctor to be of importance of the result
  • The inability to perform an Exercise challenge test with maximum effort

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Forced expiratory volume in one second (FEV1)
Time Frame: up to 4 weeks
up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Forced vital capacity (FVC)
Time Frame: up to 4 weeks
up to 4 weeks
Forced expiratory flow at 50 % FVC(FEF50%)
Time Frame: up to 4 weeks
up to 4 weeks
Fractional exhaled nitric oxide (FENO)
Time Frame: up to 4 weeks
up to 4 weeks
Total lung capacity (TLC)
Time Frame: up to 4 weeks
up to 4 weeks
Specific airway resistance (sRAW)
Time Frame: up to 4 weeks
up to 4 weeks
Specific airway conductance (sGAW)
Time Frame: up to 4 weeks
up to 4 weeks
Residual volume (RV)
Time Frame: up to 4 weeks
up to 4 weeks
Diffusing capacity (TLCO)
Time Frame: up to 4 weeks
up to 4 weeks
Maximum voluntary ventilation (MVV)
Time Frame: up to 4 weeks
up to 4 weeks
Breathing reserve (BR)
Time Frame: up to 4 weeks
up to 4 weeks
Respiratory exchange ration (RER)
Time Frame: up to 4 weeks
up to 4 weeks
Oxygen uptake peak (VO2 peak)
Time Frame: up to 4 weeks
up to 4 weeks
Heart rate peak (HR peak)
Time Frame: up to 4 weeks
up to 4 weeks
Ventilation peak (VE peak)
Time Frame: up to 4 weeks
up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Liv B Augestad, Professor, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Angell MR, Augestad LB, Haugen TS, Frostad A, Grønnerød TA, Stensrud T. Exercise-induced bronchoconstriction diagnostics: Impact of a repeated exercise challenge test. Open Journal of Respiratory Diseases 4:55-63, 2014 http://file.scirp.org/pdf/OJRD_2014043017202072.pdf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2010

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

September 23, 2010

First Submitted That Met QC Criteria

October 3, 2010

First Posted (ESTIMATE)

October 5, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2017

Last Update Submitted That Met QC Criteria

February 7, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2010/1551-4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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