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

December 14, 2012 updated by: Dr. Denis O'Donnell, Queen's University

Mechanisms of Dyspnea Relief Following Exercise Training in COPD

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Respiratory Investigation Unit at Kingston General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exertional dyspnea intensity
Time Frame: 8 weeks
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)
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multidimensional measurements of dyspnea and physiological measurements
Time Frame: 8 weeks
Activity-related dyspnea: MRC dyspnea scale, Transition Dyspnea Index, CRQ dyspnea component, SGRQ activity component
8 weeks
Dyspnea-related anxiety
Time Frame: 8 weeks
Intensity of dyspnea-related anxiety measured during cycle exercise testing (Borg scale)
8 weeks
disease-specific self-efficacy
Time Frame: 8 weeks
COPD Self-Efficacy Score
8 weeks
Pulmonary function
Time Frame: 8 weeks
Detailed measurements of pulmonary function: spirometry, body plethysmography, diffusing capacity, maximal respiratory pressures
8 weeks
Cardiopulmonary exercise test measurements
Time Frame: 8 weeks
Physiological measurements obtained during cycle exercise testing
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's University

Investigators

  • Principal Investigator: Denis O'Donnell, MD, FRCPC, Queen's University and Kingston General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

January 11, 2012

First Submitted That Met QC Criteria

January 16, 2012

First Posted (Estimate)

January 20, 2012

Study Record Updates

Last Update Posted (Estimate)

December 17, 2012

Last Update Submitted That Met QC Criteria

December 14, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMED-986-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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