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

NCT ID: NCT01513616

Last Updated: 2012-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2011-12-31

Brief Summary

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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?

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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COPD dyspnea exercise measurement respiratory physiology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Pulmonary rehabilitation

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

Group Type EXPERIMENTAL

Pulmonary rehabilitation

Intervention Type OTHER

8-week program, 3 supervised session per week

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.

Group Type SHAM_COMPARATOR

Pulmonary rehabilitation

Intervention Type OTHER

8-week program, 3 supervised session per week

Usual care

Intervention Type OTHER

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)

Interventions

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Pulmonary rehabilitation

8-week program, 3 supervised session per week

Intervention Type 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)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen's University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Denis O'Donnell

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Denis O'Donnell, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Queen's University and Kingston General Hospital

Locations

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Respiratory Investigation Unit at Kingston General Hospital

Kingston, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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DMED-986-06

Identifier Type: -

Identifier Source: org_study_id