The Effects of Non-invasive Ventilation During Cycle Exercise Within a 3-week Pulmonary Rehabilitation Program in COPD Patients With Chronic Hypercapnic Respiratory Failure - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Exercise tolerance
研究概览
简要总结
The aim of the study is to investigate the additional effects of the use of NIV during exercise within a 3-week PR program on exercise capacity in COPD patients with chronic hypercapnic respiratory failure.
详细描述
Scientific Background/ Rationale:
Quality of life and exercise tolerance are commonly reduced in people with chronic obstructive pulmonary disease (COPD), especially in people with chronic hypercapnic respiratory failure (CHRF). Endurance exercise training as part of a pulmonary rehabilitation (PR) programme is an important treatment for people with COPD and has been shown to improve quality of life, exercise tolerance and physical activity. However, individuals with CHRF may have difficulties performing endurance exercise at an adequate training intensity to achieve the desired physiological changes.
Non-invasive ventilation (NIV) is a method of providing breathing support using a ventilator and is usually delivered via a full face mask. A recent study showed that during a single exercise session in people with CHRF, NIV dramatically improves exercise tolerance and reduces breathlessness. Consequently, NIV used over a complete exercise training program may allow people with COPD and CHRF to exercise at a higher intensity to achieve greater improvement in exercise tolerance, quality of life and physical activity. So far this has only been tested in a small number of studies with small numbers of participants, and none with CHRF. It is currently not known from literature whether the demonstrated benefits of NIV during exercise training are clinically worthwhile or cost-effective.
Aims The aim of the study is to investigate the additional effects of the use of NIV during exercise within a 3-week PR program on exercise capacity in COPD patients with chronic hypercapnic respiratory failure.
Hypothesis It is assumed that a 3-week exercise training program with additional NIV, using titrated pressures, reduces the work of breathing. With this, it is theorized, COPD patients with CHRF are able to train for a longer duration and/ or with higher training intensities over the course of the training program and may achieve better PR outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Diagnosis of very severe COPD Gold Stage IV
- •Age: 40-80 years
- •PaCO2 >50mmHg (at rest, during sleep or exercise)
- •Implemented nocturnal non-invasive ventilation therapy
排除标准
- •Concomitant cardiovascular, orthopaedic or neurological conditions that are likely to be the primary impairment to exercise performance
- •Other significant pulmonary disease which could affect exercise or NIV (e.g. asthma)
- •BMI > 35 kg/m2
- •Inability to give informed consent
结局指标
主要结局
Exercise tolerance
时间窗: Day 1 and Day 21
Change in cycle endurance time without NIV within PR
次要结局
- Partial pressure of transcutaneous carbon dioxide(Day 1 and Day 21)
- Oxygen saturation(Day 1 and Day 21)
- Partial pressure of carbon dioxide(Day 1 and Day 21)
- Partial pressure of oxygen(Day 1 and Day 21)
- Patients Quality of life - Chronic Respiratory Questionnaire(Day 1 and Day 21)
- Arterial blood pressure(Day 1 and Day 21)
- Patients Quality of life - Severe Respiratory Insufficiency Questionnaire(Day 1 and Day 21)
- Patients perception - leg fatigue(Day 1 and Day 21)
- Anxiety and Depression(Day 1 and Day 21)
- Maximal voluntary muscle contraction(Day 1 and Day 21)
- Patients perception to physical Training with additional NIV(Day 1 and Day 21)
- Heart rate(Day 1 and Day 21)
- Patients perception - Dyspnoe(Day 1 and Day 21)
研究者
Klaus Kenn
Prof. Dr. Klaus Kenn
Schön Klinik Berchtesgadener Land