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

NCT01513616 | Completed

• 1 other identifier: DMED-986-06
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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:

1. 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. 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. 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. 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?

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; dyspnea; exercise; measurement; respiratory physiology

Outcome Measures

Primary Outcomes (1)

• 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)

  8 weeks

Secondary Outcomes (5)

• Multidimensional measurements of dyspnea and physiological measurements

  8 weeks

• Dyspnea-related anxiety

  8 weeks

• disease-specific self-efficacy

  8 weeks

• Pulmonary function

  8 weeks

• Cardiopulmonary exercise test measurements

  8 weeks

Study Arms (2)

Pulmonary rehabilitation

EXPERIMENTAL

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

Other: Pulmonary rehabilitation

Usual care control

SHAM COMPARATOR

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; Other: Usual care

Interventions

Pulmonary rehabilitation OTHER

8-week program, 3 supervised session per week

Pulmonary rehabilitation; Usual care control

Usual care 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)

Usual care control

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Respiratory Investigation Unit at Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Behavior

Study Officials

• Denis O'Donnell, MD, FRCPC

  Queen's University and Kingston General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 11, 2012
• First Posted: January 20, 2012
• Study Start: November 1, 2006
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 17, 2012

Record last verified: 2012-12

Locations

CA (1)