Effect of Expiratory Positive Airway Pressure on Dynamic Hyperinflation and Ability to Exercise With Upper Limbs in COPD Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Dynamic hyperinflation
研究概览
简要总结
The study will evaluate the effect of positive airway expiratory pressure (EPAP) on patients with chronic obstructive pulmonary disease (COPD) during submaximal upper limb exercise.
详细描述
The study to be developed from this project aims to evaluate the effect of positive airway expiratory pressure (EPAP) on upper limb exercise-induced dynamic hyperinflation (DH) in patients with chronic obstructive pulmonary disease (COPD). To this end, a cross-over study will be implemented, developed at the Pulmonology Department of Hospital de Clínicas de Porto Alegre. Patients with moderate to very severe, clinically stable COPD will be evaluated. The anthropometric data and pulmonary function will be collected from the medical records, being the study divided into two stages. First stage: At the first visit, dyspnea, quality of life will be evaluated and a maximal incremental cardiopulmonary exercise test (CPET) for upper limb with DH evaluation during exercise. Patients who presented DH on incremental CPET will be invited to return for a second and third visit. In the second and third visit an endurance test will be performed with 80% of the load reached in the incremental CPET and DH determination, one of the tests performed during the application of EPAP through a face mask with pressure level Of 10 cmH2O and another in usual breathing, with the mask without the use of the positive pressure generating valve. The sequence of the test, ie, with and without EPAP, will be obtained through electronic randomization. Patients completing stage 1 will be invited to enter step 2. In this step, which will occur in a single visit, patients will perform a 6-minute pegboard and ring test (6PBRT) with The same monitoring of CPET in three different situations, according to randomization: habitual breathing, half-closed lip breathing (RLS) and the EPAP mask. Thus, it is expected that the application of EPAP through face mask and the use of RLS will reduce DH during submaximal exercise with upper limb, which will be associated with the reduction of dyspnea and increased tolerance to exercise in COPD patients .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical disease stability (no signs of exacerbation within 8 weeks prior to enrollment)
- •receiving standard long-term bronchodilator (BD) therapy
- •able to perform cycle ergometer exercise for upper limbs
排除标准
- •use artificial airways
- •severe comorbidities, such as heart, orthopedic or neurological diseases that are risky or make it impossible to exercise
- •Patients on oxygen or with indication of continuous home oxygen therapy
研究组 & 干预措施
Incremental cardiopulmonary test
Incremental cardiopulmonary test for upper limbs will be performed only to identify patients who exhibit dynamic hyperinflation during upper limb exercise.
Endurance test
The endurance test for upper limbs will be performed in two conditions: In the first the patients perform the test in usual breathing, without the use of EPAP. In the second the test will be performed using the EPAP mask.
干预措施: Endurance test for upper limbs (Diagnostic Test)
Functional test
The functional test for upper limbs will be performed from protocol already published for the 6-min pegboard and ring test (6PBRT). In this stage the patients will perform the 6PBRT in usual breathing and as the use of the EPAP mask.
干预措施: Functional test (Diagnostic Test)
结局指标
主要结局
Dynamic hyperinflation
时间窗: The inspiratory capacity is assessed at rest before the cardiopulmonary exercise test (CPET) is performed, every two minutes during and immediately after the end of the test. The estimated time of the test will be 8 to 12 minutes.
Dynamic hypersensitivity is assessed through changes in inspiratory capacity.
次要结局
- Dyspnea(Dyspnea will be evaluated at rest before the cardiopulmonary exercise test (CPET) is performed, every two minutes during and immediately after the end of the test. The estimated time of the test will be 8 to 12 minutes.)
- Perception of exertion in upper limbs.(Perception of exertion in upper limbs will be evaluated at rest before the cardiopulmonary exercise test (CPET) is performed, every two minutes during and immediately after the end of the test. The estimated time of the test will be 8 to 12 minutes.)
研究者
Dannuey Machado Cardoso
Prof.
Hospital de Clinicas de Porto Alegre