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Does Pulmonary Rehabilitation Improve Breathing of COPD Patients (PR-COPD)

This study is not yet open for participant recruitment.
Verified May 2017 by University of British Columbia
Sponsor:
ClinicalTrials.gov Identifier:
NCT01815970
First Posted: March 21, 2013
Last Update Posted: May 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of British Columbia
  Purpose

Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death world-wide. Dyspnea (i.e., sensations of breathlessness) is the hallmark symptom of patients with this disease. Pulmonary rehabilitation programs that incorporate exercise training remain the most effective non-pharmacological method of reducing dyspnea in COPD, however it is not understood how exercise training relieves dyspnea. Accordingly, the purpose of this study is to determine if pulmonary rehabilitation can reduce the disparity between the drive to breathe and the breathing response in patients with COPD and to determine if this reduction is associated with improvements in dyspnea during exercise.

The investigators hypothesise pulmonary rehabilitation will reduce dyspnea at a standardized work rate and this reduction will be directly related to an improvement in the breathing response.


Condition Intervention
Pulmonary Disease, Chronic Obstructive Behavioral: Pulmonary Rehabilitation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Does Pulmonary Rehabilitation Reduce Neuromechanical Uncoupling of the Respiratory System in COPD

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Change in neuromechanical uncoupling [ Time Frame: Parameters will be measured during the 3 visits, at rest and during exercise. Visits 1 & 2 will be 48 hrs apart and within 2 weeks prior to the 8 week pulmonary rehabilitation (PR). Visit 3 will occur within 2 weeks after the completion of the PR. ]
    The relationship between the neural drive (or effort) to breathe and the corresponding mechanical response of the respiratory system.


Secondary Outcome Measures:
  • Dyspnea [ Time Frame: Parameters will be measured during the 3 visits, at rest and during exercise. Visits 1 & 2 will be 48 hrs apart and within 2 weeks prior to the 8 week pulmonary rehabilitation (PR). Visit 3 will occur within 2 weeks after the completion of the PR. ]
    Intensity (BORG scale) and qualitative dimensions (dyspnea descriptors) of dyspnea.


Estimated Enrollment: 12
Anticipated Study Start Date: May 2018
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pulmonary Rehabilitation
8 weeks of Pulmonary Rehabilitation
Behavioral: Pulmonary Rehabilitation
8 weeks of Pulmonary Rehabilitation including exercise and COPD related education.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A physician diagnosis of moderate-to-severe COPD
  • Stable clinical COPD status (no history of an acute exacerbation requiring antibiotics or prednisone in the past 4 weeks)
  • Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1.0) ≥ 30 - < 80% predicted and FEV1.0/Forced Vital Capacity ratio < 0.7
  • Body mass index > 18 or < 35 kg/m2
  • Able to read and understand English

Exclusion Criteria:

  • Concurrent participation in or recent completion (<6 weeks) of pulmonary rehabilitation
  • An ulcer or tumor in their esophagus, or a nasal septum deviation (as reported by the participant)
  • Had recent nasopharyngeal surgery
  • Have a cardiac pacemaker
  • Allergies to latex and sensitivities to local anesthetics
  • Uncontrolled hypertension
  • Diagnosis of diabetes
  • Previous physician diagnosis of cardiovascular disease including: angina, acute coronary syndrome, heart failure, cerebrovascular disease, thromboembolic disease, peripheral vascular disease
  • Other chronic lung disease including: asthma, interstitial lung disease, or pulmonary hypertension
  • Chronic hepatic disease, chronic renal disease, or other systemic inflammatory disease
  • Use of chronic oral steroids
  • Dementia or uncontrolled psychiatric illness
  • A disease other than COPD that could contribute to dyspnea or exercise limitation
  • Contraindications to clinical exercise testing
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01815970


Contacts
Contact: Sabrina S Wilkie, M.Sc. 604.806.8835 sabrina.wilkie@hli.ubc.ca
Contact: Jordan A Guenette, Ph.D. 604.682.2344 ext 62129 jordan.guenette@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, Ph.D.         
Sub-Investigator: Pat Camp, Ph.D.         
Sub-Investigator: Chris Ryerson, M.D.         
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Jordan A Guenette, Ph.D. UBC James Hogg Research Centre/ UBC Dept. Physical Therapy
  More Information

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01815970     History of Changes
Other Study ID Numbers: H13-00591
First Submitted: March 11, 2013
First Posted: March 21, 2013
Last Update Posted: May 8, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of British Columbia:
dyspnea
exercise
neuromechanical uncoupling
COPD
pulmonary rehabilitation

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive