Does Pulmonary Rehabilitation Improve Breathing of COPD Patients

NCT01815970 | Withdrawn

• 1 other identifier: H13-00591
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death world-wide. Dyspnea (i.e., sensations of breathlessness) is the hallmark symptom of patients with this disease. Pulmonary rehabilitation programs that incorporate exercise training remain the most effective non-pharmacological method of reducing dyspnea in COPD, however it is not understood how exercise training relieves dyspnea. Accordingly, the purpose of this study is to determine if pulmonary rehabilitation can reduce the disparity between the drive to breathe and the breathing response in patients with COPD and to determine if this reduction is associated with improvements in dyspnea during exercise. The investigators hypothesise pulmonary rehabilitation will reduce dyspnea at a standardized work rate and this reduction will be directly related to an improvement in the breathing response.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

dyspnea; exercise; neuromechanical uncoupling; COPD; pulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in neuromechanical uncoupling

  The relationship between the neural drive (or effort) to breathe and the corresponding mechanical response of the respiratory system.

  Parameters will be measured during the 3 visits, at rest and during exercise. Visits 1 & 2 will be 48 hrs apart and within 2 weeks prior to the 8 week pulmonary rehabilitation (PR). Visit 3 will occur within 2 weeks after the completion of the PR.

Secondary Outcomes (1)

• Dyspnea

  Parameters will be measured during the 3 visits, at rest and during exercise. Visits 1 & 2 will be 48 hrs apart and within 2 weeks prior to the 8 week pulmonary rehabilitation (PR). Visit 3 will occur within 2 weeks after the completion of the PR.

Study Arms (1)

Pulmonary Rehabilitation

EXPERIMENTAL

8 weeks of Pulmonary Rehabilitation

Behavioral: Pulmonary Rehabilitation

Interventions

Pulmonary Rehabilitation BEHAVIORAL

8 weeks of Pulmonary Rehabilitation including exercise and COPD related education.

Pulmonary Rehabilitation

Eligibility Criteria

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

You may qualify if:

• A physician diagnosis of moderate-to-severe COPD
• Stable clinical COPD status (no history of an acute exacerbation requiring antibiotics or prednisone in the past 4 weeks)
• Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1.0) ≥ 30 - \< 80% predicted and FEV1.0/Forced Vital Capacity ratio \< 0.7
• Body mass index \> 18 or \< 35 kg/m2
• Able to read and understand English

You may not qualify if:

• Concurrent participation in or recent completion (\<6 weeks) of pulmonary rehabilitation
• An ulcer or tumor in their esophagus, or a nasal septum deviation (as reported by the participant)
• Had recent nasopharyngeal surgery
• Have a cardiac pacemaker
• Allergies to latex and sensitivities to local anesthetics
• Uncontrolled hypertension
• Diagnosis of diabetes
• Previous physician diagnosis of cardiovascular disease including: angina, acute coronary syndrome, heart failure, cerebrovascular disease, thromboembolic disease, peripheral vascular disease
• Other chronic lung disease including: asthma, interstitial lung disease, or pulmonary hypertension
• Chronic hepatic disease, chronic renal disease, or other systemic inflammatory disease
• Use of chronic oral steroids
• Dementia or uncontrolled psychiatric illness
• A disease other than COPD that could contribute to dyspnea or exercise limitation
• Contraindications to clinical exercise testing

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

UBC James Hogg Research Centre, St. Paul's Hospital

Vancouver, British Columbia, V6Z1Y6, 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

• Jordan A Guenette, Ph.D.

  UBC James Hogg Research Centre/ UBC Dept. Physical Therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 11, 2013
• First Posted: March 21, 2013
• Study Start: May 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 17, 2018

Record last verified: 2018-01

Locations

CA (1)