Effect of the VitaBreath Device on Chest Wall Dynamic Hyperinflation and Respiratory Muscle Activation During Recovery From Exercise in Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- The magnitude of change in thoracoabdominal wall dynamic hyperinflation.
研究概览
简要总结
The VitaBreath (Philips, Respironics) is a portable, handheld, battery powered, non-invasive ventilation device, that has been shown to reduce activity-related shortness of breath in patients with COPD. The VitaBreath device delivers 18 cmH2O inspiratory and 8 cmH2O expiratory pressures, but can only be used during recovery periods.
A previous study (REC: 17/NE/0085) showed that use of the VitaBreath device during the recovery periods interspersing successive exercise bouts enhances exercise tolerance and reduces breathlessness compared to pursed lip breathing in patients with COPD. This was attributed to faster recovery from exercise-induced dynamic hyperinflation, assessed by volitional inspiratory capacity manoeuvres using a spirometer. However, inspiratory capacity manoeuvres are effort dependent, thus limiting the number of repetitions the patient can perform during exercise. In addition, investigation of the direct effect of the application of the VitaBreath device on dynamic hyperinflation was not possible due to the need to employ a spirometer for assessing inspiratory capacity. Optoelectronic plethysmography (OEP) allows continuous non-invasive assessment of end-inspiratory and end-expiratory volumes of the thoracoabdominal wall and its compartments, thereby facilitating assessment of dynamic hyperinflation on a breath-by-breath basis without the necessity to breathe via a spirometer. Unfortunately, OEP technology was not available at the time of our previous study.
The investigators will use OEP to provide accurate breath-by-breath volume measurements during exercise and recovery to evaluate whether the VitaBreath device reduces total and compartmental thoracoabdominal wall volumes compared to the pursed lip breathing technique.
Furthermore, the investigators will investigate the effect of use of the VitaBreath device on respiratory muscle activation and respiratory muscle oxygenation using OEP technology in conjunction with electromyography (EMG) and near inferred spectroscopy (NIRS), respectively to appreciate how the application of the VitaBreath device impacts on the operation and energy demands of the respiratory muscles as compared to control pursed lip breathing.
The investigators hypothesised that the use of the VitaBreath device during the recovery periods interspersing successive exercise bouts will reduce the magnitude of dynamic hyperinflation in a greater extent compared to the pursed lip breathing technique.
详细描述
Study Design:
This is a randomised crossover trial. Patients will perform two identical exercise tests and the intervention (VitaBreath) will be compared to control condition (pursed-lip breathing) in the same patients. The order of testing will be determined by simple randomisation (sealedenvelope.com).
The purpose of this study is to investigate the effect of the VitaBreath device on inspiratory and expiratory thoracoabdominal wall volumes during exercise in patients with COPD. Use of the VitaBreath device will be compared to normal breathing (pursed lip breathing technique). Patients will primarily be recruited from those who participated in our previous study (REC reference: 17/NE/0085 - IRAS project ID: 221120) at North Tyneside General Hospital and will undergo two exercise tests on a cycle ergometer on the same day using both the VitaBreath device and the pursed-lip breathing technique during recovery from exercise.
Study interventions:
The study will include two visits. During the first visit patients will undergo a clinical assessment, including history, physical examination, ECG and full lung function assessment including spirometry, to ensure that patients are stable. During the second visit patients will perform two intermittent exercise tests lasting 20 minutes each and consisting of 2-min work bouts at 80% of peak work rate (WR peak) as determined in the previous study (REC reference: 17/NE/0085 - IRAS project ID: 221120) with 2-min recovery periods in between work bouts, using either the VitaBreath device or the pursed lip breathing technique during recovery periods. Patients will be given written information explaining the procedure and will provide written informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 40 years or older.
- •Current or previous smoking history: 10 or more pack years.
- •Spirometry confirmed stable COPD (GOLD stages II-IV) under optimal medical therapy.
- •Exhibit substantial exercise-induced dynamic hyperinflation (ΔIC baseline > 0,150 L)
排除标准
- •Orthopaedic, neurological or other concomitant diseases that significantly impair normal biomechanical movement patterns, as judged by the investigator.
- •Moderate or severe COPD exacerbation within 6 weeks.
- •Unstable cardiac arrhythmia.
- •Unstable ischaemic heart disease, including myocardial infarction within 6 weeks.
- •Moderate or severe aortic stenosis or hypertrophic obstructive cardiomyopathy.
- •Uncontrolled hypertension.
- •Uncontrolled hypotension (SBP<85mmHg).
- •Uncontrolled diabetes.
- •Intolerance of the VitaBreath device.
结局指标
主要结局
The magnitude of change in thoracoabdominal wall dynamic hyperinflation.
时间窗: The intervention will be performed in one visit. During the visit patients will perform 2 trials lasting for 20 minutes each. The outcome 1 will be assessed at rest, at the 20th minute of cycling and 5 minutes post cycling at each trial.
Change from baseline in litres of thoracoabdominal wall volume at end of exercise and recovery from exercise from resting breathing.
次要结局
- Compartmental thoracoabdominal wall volumes (rib cage and abdominal volumes) assessed by OEP.(The intervention will be performed in one visit. During the visit patients will perform 2 trials lasting for 20 minutes each. The outcome 2 will be assessed at rest, at the 20th minute of cycling and 5 minutes post cycling at each trial.)
- Electromyographic activation (expressed as fractions of peak activation and in absolute terms in mV) assessed by surface electromyography(The intervention will be performed in one visit. During the visit patients will perform 2 trials lasting for 20 minutes each. The outcome 3 will be assessed at rest, at the 20th minute of cycling and 5 minutes post cycling at each trial.)
- Respiratory muscle oxygenation requirements recorded from the intercostal and abdominal muscles by near infrared spectroscopy including measurements of: total haemoglobin (TOI), oxygenated haemoglobin (HbO2) and deoxygenated haemoglobin (HHb).(The intervention will be performed in one visit. During the visit patients will perform 2 trials lasting for 20 minutes each. The outcome 4 will be assessed at rest, at the 20th minute of cycling and 5 minutes post cycling at each trial.)
- Cardiac output responses assessed non-invasively by cardio impedance technology(The intervention will be performed in one visit. During the visit patients will perform 2 trials lasting for 20 minutes each. The outcome 5 will be assessed at rest, at the 20th minute of cycling and 5 minutes post cycling at each trial.)