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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pulmonary rehabilitation
Usual care
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, dyspnea, exercise, measurement, respiratory physiology

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Respiratory Investigation Unit at Kingston General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Pulmonary rehabilitation

Usual care control

Arm Description

A supervised 8-wk outpatient pulmonary rehabilitation program consisting of multi-modality exercise training and COPD self-management education.

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.

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
January 11, 2012
Last Updated
December 14, 2012
Sponsor
Queen's University
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1. Study Identification

Unique Protocol Identification Number
NCT01513616
Brief Title
The Impact of Pulmonary Rehabilitation on Dyspnea in Chronic Obstructive Pulmonary Disease
Official Title
Mechanisms of Dyspnea Relief Following Exercise Training in COPD
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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: 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. 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. 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. 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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, dyspnea, exercise, measurement, respiratory physiology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulmonary rehabilitation
Arm Type
Experimental
Arm Description
A supervised 8-wk outpatient pulmonary rehabilitation program consisting of multi-modality exercise training and COPD self-management education.
Arm Title
Usual care control
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pulmonary rehabilitation
Intervention Description
8-week program, 3 supervised session per week
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
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)
Primary Outcome Measure Information:
Title
Exertional dyspnea intensity
Description
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)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Multidimensional measurements of dyspnea and physiological measurements
Description
Activity-related dyspnea: MRC dyspnea scale, Transition Dyspnea Index, CRQ dyspnea component, SGRQ activity component
Time Frame
8 weeks
Title
Dyspnea-related anxiety
Description
Intensity of dyspnea-related anxiety measured during cycle exercise testing (Borg scale)
Time Frame
8 weeks
Title
disease-specific self-efficacy
Description
COPD Self-Efficacy Score
Time Frame
8 weeks
Title
Pulmonary function
Description
Detailed measurements of pulmonary function: spirometry, body plethysmography, diffusing capacity, maximal respiratory pressures
Time Frame
8 weeks
Title
Cardiopulmonary exercise test measurements
Description
Physiological measurements obtained during cycle exercise testing
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis O'Donnell, MD, FRCPC
Organizational Affiliation
Queen's University and Kingston General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Respiratory Investigation Unit at Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada

12. IPD Sharing Statement

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

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