Does Pulmonary Rehabilitation Reduce Neuromechanical Uncoupling of the Respiratory System in COPD
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in neuromechanical uncoupling
研究概览
简要总结
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.
详细描述
The purpose of this study is to determine if 8 weeks of pulmonary rehabilitation can reduce neuromechanical uncoupling (a disparity between the effort/drive to breathe and the breathing response) in patients with COPD and to determine if this reduction is associated with improvements in both the intensity and qualitative dimensions of dyspnea during exercise.
Pulmonary rehabilitation is an exercise and education intervention designed to help patients cope with their dyspnea, and exercise effectively. Pulmonary rehabilitation programs that incorporate exercise training are the most effective non-pharmacological method of reducing dyspnea in COPD. However, the precise mechanisms of dyspnea relief following exercise training are still unknown. Understanding the pathophysiologcal underpinnings of this debilitating symptom is critical in order to develop effective symptom-based strategies for dyspnea management.
Participants with COPD will report to the exercise laboratory on 3 separate visits. Visit 1 will serve as an initial screening visit whereby participants will provide written informed consent prior to familiarization of all testing procedures and symptom scales followed by completion of an incremental cycle exercise test. The remaining 2 experimental visits will be conducted immediately before and after 8 weeks of pulmonary rehabilitation. Visits 2 and 3 will include: symptom-related questionnaires, pulmonary function tests, functional ability test and a constant-work rate (CWR) cycle exercise test at 75% of the maximal work rate achieved during visit 1. The CWR cycle exercise tests will be performed with the instrumentation of an esophageal catheter and detailed physiological and sensory measurements will be obtained on both visits. The comparison of data from visits 2 and 3 will address the investigators' hypotheses.
Study Participants: The study will include 12 COPD participants in total. Pulmonary Rehabilitation: The pulmonary rehabilitation program provides education and exercise training for patients with chronic lung disease to assist them with symptom management and improve their daily ability to function. The 8 week program involves 3 visits per week for 2 hours each visit (1 hour education and 1 hour exercise training). The pulmonary rehabilitation program is usual care for all participants in this study.
Exercise Protocol: A symptom-limited incremental exercise test will be performed on visit 1 using an electronically braked cycle ergometer according to recommended guidelines. The test will consist of steady-state rest for 10 minutes, a 1 minute warm-up at 0 watts, and 10 watt stepwise increases in work rate every minute until symptom-limitation. The CWR test performed on visits 2 and 3 will consist of a 1 minute warm-up followed by an increase in work rate to 75% of the maximum incremental work rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Pulmonary Rehabilitation
8 weeks of Pulmonary Rehabilitation
干预措施: Pulmonary Rehabilitation (Behavioral)
结局指标
主要结局
Change in neuromechanical uncoupling
时间窗: 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.
The relationship between the neural drive (or effort) to breathe and the corresponding mechanical response of the respiratory system.
次要结局
- 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.)
研究者
Jordan Guenette
Assistant Professor
University of British Columbia