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

This study has been completed.
Sponsor:
Collaborator:
Klinikk for allergi og luftveissykdommer
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01214551
First received: September 23, 2010
Last updated: February 7, 2017
Last verified: February 2017
  Purpose
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.

Condition
Exercise Induced Bronchoconstriction

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Exercise-induced Bronchoconstriction Diagnostics: Impact of a Repeated Exercise Challenge Test

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Forced expiratory volume in one second (FEV1) [ Time Frame: up to 4 weeks ]

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

Enrollment: 20
Actual Study Start Date: August 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects referred to Klinikk for allergi og luftveissykdommer
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01214551

Locations
Norway
Klinikk for allergi og luftveissykdommer
Oslo, Ullevål, Norway, 0855
Sponsors and Collaborators
Norwegian University of Science and Technology
Klinikk for allergi og luftveissykdommer
Investigators
Principal Investigator: Liv B Augestad, Professor Norwegian University of Science and Technology
  More Information

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

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01214551     History of Changes
Other Study ID Numbers: 2010/1551-4 
Study First Received: September 23, 2010
Last Updated: February 7, 2017

ClinicalTrials.gov processed this record on February 20, 2017