Trial record 5 of 356 for:    pulmonary rehabilitation

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01815970
First received: March 11, 2013
Last updated: May 21, 2014
Last verified: May 2014
  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: 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Intensity (BORG scale) and qualitative dimensions (dyspnea descriptors) of dyspnea.


Estimated Enrollment: 12
Study Start Date: May 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01815970     History of Changes
Other Study ID Numbers: H13-00591
Study First Received: March 11, 2013
Last Updated: May 21, 2014
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on August 20, 2014