Acute Effects of Combined Exercise and Oscillatory Positive Expiratory Pressure Therapy on Sputum Properties and Lung Diffusion Capacity in Cystic Fibrosis: a Randomized Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 3
- 主要终点
- Change in sputum viscoelasticity (G*) over a broad frequency range (1-100 rad.s-1)
研究概览
简要总结
The investigators aim to compare a single bout of moderately intense cycling exercise incorporating Flutter® breathing maneuvers with a single bout of moderately intense cycling exercise alone on sputum viscoelasticity (primary endpoint) and the diffusion capacity of the lungs in adult patients with cystic fibrosis.
The investigators further aim to analyze the short-term variability of resting diffusion capacity of carbon monoxide (DLCO) and nitric oxide (DLNO) in patients with cystic fibrosis.
详细描述
Regular airway clearance is an integral component of cystic fibrosis care and of critical importance to lung health. Exercise and standardized chest physiotherapy are accepted airway clearance techniques in cystic fibrosis. Different airway clearance techniques are available, but there is no evidence that one technique or a combination is superior. Oscillatory positive expiratory pressure with the Flutter® is a widely used airway clearance technique in the European countries and has been shown to favourably alter sputum viscoelasticity in cystic fibrosis.
This randomized crossover study is designed to assess the acute effects of combined cycling exercise and Flutter® therapy on sputum viscoelasticity (primary outcome measure) and gas diffusion in adults with cystic fibrosis.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of CF based on either two CF-causing mutations and/or a sweat chloride concentration during two tests of > 60 mmol/l
- •Patients that are able to provide sputum samples
- •Adult age ≥ 18 years
排除标准
- •Unstable condition affecting participation in the exercise experiments (i.e., major hemoptysis or pneumothorax within the last 3 months, acute exacerbation and iv-antibiotics during the last 4 weeks, unstable allergic bronchopulmonary aspergillosis, listed for lung transplantation, major musculoskeletal injuries such as fractures or sprains during the last 2 months, others according to the impression of the doctor)
- •Cardiac arrhythmias with exercise
- •Requiring additional oxygen with exercise
- •Colonization with Burkholderia cenocepacia
- •Status post lung transplantation
研究组 & 干预措施
Cycling in combination with Flutter® therapy
Participants perform 30 minutes of moderately intense cycling exercise in 4-min intervals at 75% of their maximal heart rate and interspersed with 2-min resting periods during which 6-8 breathing maneuvers are performed with the Flutter®.
干预措施: Flutter® (Device)
Cycling without Flutter® therapy
Participants perform 30 minutes of continuous moderately intense cycling exercise at 75% of their maximal heart rate without additional Flutter® breathing maneuvers.
干预措施: No Flutter® (Device)
结局指标
主要结局
Change in sputum viscoelasticity (G*) over a broad frequency range (1-100 rad.s-1)
时间窗: Baseline - immediately post exercise - 45min post exercise
Sputum viscoelasticity measured by stress/strain controlled rheometer (Anton Paar, MCR 301/MCR 501).
次要结局
- Change in lung diffusion capacity for nitric oxide (DLNO)(Baseline - immediately post exercise - 45min post exercise)
- Change in DLNO/DLCO ratio(Baseline - immediately post exercise - 45min post exercise)
- Change in pulmonary capillary blood volume(Baseline - immediately post exercise - 45min post exercise)
- Change in oxygen saturation (%)(Baseline - immediately post exercise - 45min post exercise)
- Change in sputum solids content (%)(Baseline - immediately post exercise - 45min post exercise)
- Change in lung diffusion capacity for carbon monoxide (DLCO)(Baseline - immediately post exercise - 45min post exercise)
- Change in alveolar volume(Baseline - immediately post exercise - 45min post exercise)
- Change in pulmonary membrane diffusion capacity(Baseline - immediately post exercise - 45min post exercise)
- Change in ease of sputum expectoration (cm)(Baseline - immediately post exercise - 45min post exercise)
- Change in shear viscosity (η)(Baseline - immediately post exercise - 45min post exercise)
- Change in sputum spinnability (mm)(Baseline - immediately post exercise - 45min post exercise)