Evaluating Sensations of Breathlessness in Patients With Cystic Fibrosis (CF_Dyspnea)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01799642
First received: February 25, 2013
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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.


Condition
Lung; Disease
Cystic Fibrosis
Healthy

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Qualitative Descriptors of Dyspnea During Exercise in Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • To determine if dyspnea is qualitatively and quantitatively different in patients with cystic fibrosis compared with age and sex-matched healthy controls during exercise [ Time Frame: Parameters will be measured during the 1 visit. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • To determine if the dyspnea responses can be explained by differences in the ventilatory response to exercise. [ Time Frame: Parameters will be measured during the 1 visit. ] [ Designated as safety issue: No ]
    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. The point at which the tidal volume deviates from linearity and begins to plateau will be defined as the inflection point of the tidal volume and minute ventilation relationship. Two different observers will determine the inflection point for each participant during the incremental exercise test by examining individual Hey plots.


Estimated Enrollment: 40
Study Start Date: June 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cystic Fibrosis Patients
Participants with Cystic Fibrosis
Healthy Controls
Participants who do not have cystic fibrosis and are otherwise healthy.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  • CF patients (confirmed based on abnormal sweat chloride testing and/or CF Transmembrane Conductance Regulator (CFTR) genotyping)
  • Between the ages of 19 to 50 (inclusive)
  • Stable clinical status (CF: no changes in therapy in the past 4 weeks)
  • Forced Expiratory Volume in 1 second (FEV1.0) >40% predicted
  • Body mass index greater than 18 or less than 30
  • Currently non-smoking or a past smoking history of less than 20 pack-years
  • Able to read and understand English

Exclusion Criteria:

  • A disease other than CF that could contribute to dyspnea or exercise limitation
  • Having either of the chronic infections Mycobacterium abscessus or Burkholderia cepacia complex
  • Contraindications to clinical exercise testing
  • Use of supplemental oxygen or desaturation less than 85% with exercise
  • Diagnosis of pneumothorax in the past 4 weeks
  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: NCT01799642

Contacts
Contact: Sabrina S Wilkie, MSc 604.806.8835 sabrina.wilkie@hli.ubc.ca

Locations
Canada, British Columbia
UBC James Hogg Research Centre, St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z1Y6
Principal Investigator: Jordan A Guenette, PhD         
Sub-Investigator: Pearce G Wilcox, MD         
Sub-Investigator: Bradley S Quon, MD         
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Jordan A Guenette, PhD UBC James Hogg Research Centre
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01799642     History of Changes
Other Study ID Numbers: H13-00262
Study First Received: February 25, 2013
Last Updated: July 3, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
dyspnea
exercise
cystic fibrosis
neuromechanical dissociation

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Lung Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014