NCT01799642|Completed
Evaluating Sensations of Breathlessness in Patients With Cystic Fibrosis
CF_Dyspnea
Qualitative Descriptors of Dyspnea During Exercise in Cystic Fibrosis
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CF_Dyspnea
Qualitative Descriptors of Dyspnea During Exercise in Cystic Fibrosis
Sponsor study identifier
observational
50
1 country
1
Study Start
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Actual (reported)Study Completion
December 2014
Actual (reported)Shortness of breath (dyspnea) during exercise is a major source of distress and is a commonly reported symptom in patients with cystic fibrosis (CF). Due to the investigators' poor understanding of how dyspnea develops, there are no treatments that consistently reduce dyspnea in this population. The investigators aim to acquire a more comprehensive understanding of the physiological mechanisms of exertional dyspnea in CF patients. This study will likely identify an important physiological mechanism of dyspnea in CF and may contribute to the development and use of effective treatments to reduce dyspnea in this population. The central hypothesis is that the impaired tidal volume (VT) response during exercise in CF, in the setting of increased ventilatory demand will give rise to different qualitative descriptions of exertional dyspnea compared with healthy age and sex-matched controls. Specifically, CF patients will select "increased work and effort" as their dominant descriptor of dyspnea up to the VT inflection/plateau. Beyond this point, CF patient's dominant descriptor will become "unsatisfied inspiration." In contrast, healthy control participants will report "increased work and effort" throughout all phases of exercise and will not report "unsatisfied inspiration", even after the VT inflection/plateau.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 25, 2013
Actual (reported)February 27, 2013
Actual (reported)June 2013
Date type not reportedThis date has not been verified as actual or estimated.
December 2014
Actual (reported)December 2014
Actual (reported)To determine if dyspnea is qualitatively and quantitatively different in patients with cystic fibrosis compared with age and sex-matched healthy controls during exercise
Included will be 20 patients with cystic fibrosis (CF) who have no other pulmonary or extra-pulmonary limitation to exercise, as well as 20 healthy age and sex-matched control participants. All participants (CF and control) will perform an incremental symptom-limited cardio-pulmonary exercise test while detailed cardio-respiratory responses, dyspnea responses, muscle oxygenation and muscle hemodynamic data are measured.
Parameters will be measured during the 1 visit.
To determine if the dyspnea responses can be explained by differences in the ventilatory response to exercise.
Parameters will be measured during the 1 visit.
Participants with Cystic Fibrosis
Participants who do not have cystic fibrosis and are otherwise healthy.
The CF patients will be recruited from the St. Paul's Hospital Adult CF Clinic. Healthy control participants will be recruited from the Vancouver area.
UBC James Hogg Research Centre, St. Paul's Hospital
Vancouver, British Columbia, V6Z1Y6, Canada
Jordan A Guenette, PhD
UBC James Hogg Research Centre
50 participants (actual enrollment reported by the registry).
First Submitted
February 25, 2013
First Posted
February 27, 2013
Study Start
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
December 2014
Actual (reported)Study Completion
December 2014
Actual (reported)Last Updated
November 20, 2015
Record last verified: 2015-11
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Source: ClinicalTrials.gov.
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