Effect of Exercise Training Under High Flow Oxygen (HFO) Device on Endurance Tolerance in Patients With COPD and Chronic Respiratory Failure: a Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 171
- 试验地点
- 1
- 主要终点
- Effectiveness on endurance tolerance
研究概览
简要总结
Current literature clearly shows the benefit of pulmonary rehabilitation in symptomatic COPD (Trooster,2005). However, these patients are frequently unable to sustain a work-load sufficiently high to obtain a full benefit on exercise tolerance (Trooster,2005). Especially in patients with Chronic Respiratory Failure (CRF), the development of hypoxia (O'Donnel,2001) and the increase of dead space (Elbehairy,2015) during effort explain the out-of-proportion increase in ventilation leading to an early achievement of the ventilatory reserve. Recent studies on heated and humidified high flow oxygen (HFO) delivered through nasal cannula, show several positive effects on breathing pattern and ventilatory efficiency, mostly in critical care setting and at rest (Spoletini,2015). Some recent physiological studies have evidenced that high flows of humidified oxygen improve exercise performance in patients with COPD and severe oxygen dependency, in part by enhancing oxygenation (Chatila,2004). Recently, a pilot study by our group showed that HFO may improve the exercise performance in severe COPD patients with ventilatory limitation. This effect is associated to an improvement of oxygen saturation (SatO2) and perceived symptoms at iso-time (Cirio,2016). No clinical studies are available about the use of HFO during exercise training. The investigators hypothesize that, in severe COPD patients with CRF and exercise limitation , the use of HFO could improve the efficiency of ventilation, leading to an increase in the patient's exercise performance and outcome.
Primary aim will be to evaluate in patients COPD with CRF the difference in the endurance tolerance improvement (expressed in minutes) after an high intensity training program, at iso-FiO2, using HFO with respect to usual oxygen administration by " Venturi Mask" .
Secondary objectives will be to study effectiveness of HFO with respect to "Venturi Mask" in terms of improvement of meters of 6 Minute Walking Test, dyspnea at rest, peripheral and respiratory muscle strength,blood gases, motor and respiratory disability,quality of life,impact of the disease and patients satisfaction.
详细描述
160 patients will be enrolled in 4 different hospitals. One of those, ICS Maugeri, will contribute with 5 different Institutes [Brescia, Pavia, Tradate (VA),Veruno (NO) and Cassano delle Murge (BA)]. Thus the total recruiting centers will be eight.
During the whole rehabilitation period, the patients will perform one training session/day.
The patients will use medications and oxygen therapy at rest as prescribed. The patients will perform no less than 20 training sessions within a period of one month. The rehabilitative intervention will be constantly supervised by a respiratory therapist.
The cycle load started from the 50% of the theoretical maximum watt (evaluated by 6 minutes walking test [6MWT] through the Luxton's equation) (Luxton,2008) and increased by Maltais's protocol (Maltais,1997). Run-in training session: all patients will be submitted to a preliminary 30 minute training under a Venturi mask to set the FiO2 able to maintain SpO2 constantly up to 93%. Usual nocturnal ventilation and nocturnal oxygen therapy under nasal cannula will be allowed.
Patients will be randomized to 2 groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Care Provider)
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
- •COPD and CRF diagnosis under LTOT,
- •clinical stability (pH > 7.35 and < 7.46, no change in respiratory drugs therapy during the last seven days)
排除标准
- •orthopedic or neurological disease,
- •cognitive impairment (Mini Mental State Examination < 22)
- •anamnestic history of ischemic heart disease or heart failure, COPD+ fibrosis and COPD+ OSAS.
研究组 & 干预措施
Oxygen
The training will be performed using oxygen by the Venturi mask with the FiO2 set during the run - in session.
HFO
The training will be performed using the HFO device during the run - in session at iso_FiO2 as in the Control Group (Oxygen by Venturi mask).
干预措施: HFO (Device)
结局指标
主要结局
Effectiveness on endurance tolerance
时间窗: At Baseline
To evaluate the difference in the endurance tolerance improvement (endurance time) with a costant load cycloergometer test.
次要结局
- Effectiveness on blood gases(At one month)
- Effectiveness on quality of life(At 1 month)
- Effectiveness on functional capacity(At 1 month)
- Effectiveness on respitarory muscle strength(At 1 month)
- Effectivenes on satisfaction(At 1 month)
- Effectiveness on dyspnea(At 1 month)
- Effectiveness on peripheral muscle strenght(At 1 month)
- Effectiveness on disability(At 1 month)
- Effectiveness on impact of the disease(At 1 month)