Measurement of Exertional Dyspnea in the Primary Care Setting in Patients With COPD, Phase III: Sensitivity of the Step Test to Detect Improvement in Dyspnea Following Bronchodilation in Patients With COPD
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Symptom perception
研究概览
简要总结
During the previous phases of the project (Phase I and II), two new field tests have been designed and validated for an integration in a primary care setting in Chronic Obstructive Pulmonary Disease (COPD). These new field tests are 3-min paced-walk test (3MPWT) and 3-min paced step test (3MPST). If the validity and sensitivity of the TM3 could be highlighted, particularly by the reduction of dyspnea level following bronchodilatation, Phase II highlight that the 3MPST does not allow to detect this decrease of dyspnea after bronchodilatation. The use of too high step rates could explain these results through a hypothesis relative to neuromechanical coupling of dyspnea. The main objective of this trial is to follow the investigations on the sensitivity of 3MPST to detect the effects of pharmacological intervention on the exertional dyspnea in COPD patient. The hypothesis of this work is that the use of lower step rates cadences could allow to detect an improvement of exertional dyspnea following treatment-induced bronchodilatation, contrary to higher step rates.
详细描述
For this project, 40 patients with COPD will be recruited in 2 centres (in the Institute of Cardiology and Pneumology of Quebec and in the Chest Institute of Montreal). For each patient, three visits will be performed. During the first visit, baseline pulmonary function and maximal exercise capacity will be evaluated and the patients will be familiarized with step test proceedings. Between the different visits, a 3-7 days period will be respected. During the second and the third visits, 4 step tests will be performed at 4 different rates, following one of the two conditions (placebo or bronchodilatation). This project will propose two randomization levels. The first randomization will be relative to the choice of the condition used during the second visit (placebo ou bronchodilatation) and the second one for the rates order (14, 16, 20, 24 steps/min). During each performed exercise, cardiorespiratory and pulmonary parameters will be measured using a portable system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age higher than 50 years old
- •smoking history ≥ 10 packs/year
- •post-bronchodilator FEV1 between 30 and 80% of the predicted value and FEV1/FVC lesser than 70% as assessed in previous pulmonary function test (corresponding to GOLD stages II and III)
排除标准
- •respiratory exacerbation within the preceding 6 weeks
- •asthmatic condition
- •significant O2 desaturation (SaO2 < 85%) at rest or during exercise
- •presence of another pathology that could influence exercise tolerance or may prevent the realization of the step test
- •subject having a pacemaker
研究组 & 干预措施
COPD group
Moderate and/or severe COPD patients, corresponding to GOLD stages II and III.
干预措施: Combination ipratropium/salbutamol or placebo (nebulization) (Drug)
结局指标
主要结局
Symptom perception
时间窗: change from baseline in Borg Scale at 3 min of exercise
Patients will be asked to score their dyspnea and leg discomfort perception using a 10-point Borg scale.
次要结局
- Pulmonary function(At baseline and 60-min after the nebulization of either placebo and bronchodilator)
- Cardiac and ventilatory outcomes(Change from baseline at 3 minutes of exercise)
- Inspiratory capacity(Change from baseline at the end of the exercise.)
- Respiratory pressures and diaphragm EMG(Change from baseline at 1, 2 and 3 minutes of exercise)
- Maximal oxygen consumption(Change from baseline at 1, 2 and 3 minutes of exercise)
- Maximal inspiratory pressure (PImax)(Change from baseline after 3 minutes of exercise)
研究者
Benoit Borel
Postdoctoral fellow
Laval University