Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Impact of Pulmonary Rehabilitation on Dyspnea in Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Denis O'Donnell, Queen's University
ClinicalTrials.gov Identifier:
NCT01513616
First received: January 11, 2012
Last updated: December 14, 2012
Last verified: December 2012
  Purpose

Dyspnea (respiratory discomfort) and activity limitation are the most common symptoms of chronic obstructive pulmonary disease (COPD) and contribute importantly to a perceived poor quality of life. Recent international guidelines have stressed the importance of dyspnea alleviation and improvement exercise tolerance as a means of enhancing quality of life and other long term outcomes in this population. Modern pharmacotherapy is the first step in symptom management but the overall impact of bronchodilator therapy is relatively small. Exercise training remains the most effective treatment for ameliorating dyspnea and improving exercise endurance and was the main focus of this study.

The main objectives of the study were:

  1. To conduct and compare detailed studies of respiratory mechanics during cycle exercise before and after exercise training (EXT) compared with an untrained control group. By multiple regression analysis, the investigators will establish the main contributors to dyspnea relief after EXT.
  2. To compare the magnitude of change in endurance during constant work rate cycle exercise with those measured during walk tests and the endurance shuttle walk test after EXT relative to control. To evaluate which test (constant work rate cycle, six-minute walk test, or endurance shuttle walk test) is the most sensitive test for measuring changes in endurance after EXT versus control.
  3. To compare the change in standardized dyspnea ratings (Borg Scale) during constant-load cycling with a variety of other activity-related dyspnea questionnaires. To evaluate which of these measurements is the most sensitive for examining changes in perceived discomfort during exercise.
  4. To evaluate the contribution of psychological factors (anxiety, fear, respiratory panic, self-efficacy) to the perceived improvement of symptoms following EXT. The investigators will use multiple regression analysis to examine associations between changes in perceived dyspnea and changes in anxiety and self-efficacy measured by validated questionnaires and Borg intensity ratings?

Condition Intervention
Chronic Obstructive Pulmonary Disease
Other: Pulmonary rehabilitation
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mechanisms of Dyspnea Relief Following Exercise Training in COPD

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Exertional dyspnea intensity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Post-intervention comparisons (pulmonary rehabilitation vs. usual care control) of dyspnea measurements (i.e., Borg ratings at a standardized time during high-intensity constant-work rate cycle exercise testing)


Secondary Outcome Measures:
  • Multidimensional measurements of dyspnea and physiological measurements [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Activity-related dyspnea: MRC dyspnea scale, Transition Dyspnea Index, CRQ dyspnea component, SGRQ activity component

  • Dyspnea-related anxiety [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Intensity of dyspnea-related anxiety measured during cycle exercise testing (Borg scale)

  • disease-specific self-efficacy [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    COPD Self-Efficacy Score

  • Pulmonary function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Detailed measurements of pulmonary function: spirometry, body plethysmography, diffusing capacity, maximal respiratory pressures

  • Cardiopulmonary exercise test measurements [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Physiological measurements obtained during cycle exercise testing


Enrollment: 48
Study Start Date: November 2006
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pulmonary rehabilitation
A supervised 8-wk outpatient pulmonary rehabilitation program consisting of multi-modality exercise training and COPD self-management education.
Other: Pulmonary rehabilitation
8-week program, 3 supervised session per week
Sham Comparator: Usual care control
An 8-wk control period consisting of usual medical care which included optimization of respiratory medications, instructions on how best to manage COPD, standard access to treatment in the event of an exacerbation, self-management education.
Other: Pulmonary rehabilitation
8-week program, 3 supervised session per week
Other: Usual care
An 8-week control period (includes optimization of respiratory medications, instructions on how best to manage COPD, standard access to treatment in the event of an exacerbation, self-management education)

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of COPD
  • clinically stable
  • presence of activity-related dyspnea (Baseline Dyspnea Index < 9)
  • 40-80 years of age

Exclusion Criteria:

  • other significant disorders or diseases that could interfere with conduct of the intervention or tests
  • body mass index < 18 or > 40 kg/m2
  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: NCT01513616

Locations
Canada, Ontario
Respiratory Investigation Unit at Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Denis O'Donnell, MD, FRCPC Queen's University and Kingston General Hospital
  More Information

No publications provided

Responsible Party: Dr. Denis O'Donnell, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT01513616     History of Changes
Other Study ID Numbers: DMED-986-06
Study First Received: January 11, 2012
Last Updated: December 14, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Queen's University:
COPD
dyspnea
exercise
measurement
respiratory physiology

Additional relevant MeSH terms:
Dyspnea
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on November 27, 2014