Acute Effects of Oxygen Administration on Neuromuscular Fatigue in Chronic Obstructive Pulmonary Disease Patients With Chronic Respiratory Failure and Long-term Oxygen Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change of maximal voluntary activation (VA)
研究概览
简要总结
The literature on the physiological response (vasodilation, neuromuscular fatigue, and muscle oxygenation) following the application of different dosages of oxygen therapy in patients with Chronic Respiratory Failure (CRF) and Long-Term Oxygen Therapy (LTOT) during exercise is scant. The evaluation of these aspects can allow the clinicians and the rehabilitation staff to correctly dose the oxygen therapy at rest and during exercise and to reach a higher level of improvement after training. For this purpose, we will recruit 20 patients admitted to the Pulmonary Unit of the ICS Maugeri in Lumezzane (BS) with the presence of CRF defined as PaO2 at room air less than 60 mmHg, the need for LTOT since 3 months, and with a stable clinical condition. This is a crossover study and will last 3 days. We will test the same subject, randomly, in the following three conditions: A) CONDITION ROOM AIR: patient will breathe room air through the Venturi mask (Vmask FiO2 21%) and will be considered as "sham condition" B) CONDITION FiO2 30%: the subject will breathe through a Venturi mask with a FiO2 of 30%. C) CONDITION FiO2 60%: the subject will breathe through a Venturi mask with a FiO2 of 60%. During each condition, we will evaluate: a) oxygen saturation (SatO2), transcutaneous paCO2 value (tcCO2), BORG fatigue and dyspnea, blood gas analysis; b) mitochondrial function through the Near Infra-Red Spectroscopy and c) vascular function by Single Passive Leg Movement (sPLM) technique; d) central and peripheral neuromuscular fatigue after a submaximal intermittent isometric contraction. The present project will help to understand the best doses of oxygen therapy to allow patients to achieve a higher level of vasodilation and mitochondrial function and a lower level of neuromuscular fatigue. We could apply these results to the rehabilitation program in order to get a greater level of improvement in exercise tolerance.
详细描述
Advanced Chronic Obstructive Pulmonary Disease (COPD) with Chronic Respiratory Failure (CRF) and long-term oxygen therapy (LTOT) need is a condition with a poor prognosis that causes symptoms such as dyspnea and fatigue that dramatically reduce the quality of life of the person with COPD. Typically, the advanced phase of COPD is characterized by a fluctuating pattern with recurrent hospitalizations, and a vicious cycle in which dyspnea increases and exercise tolerance and physical activity are reduced, which in turn lead to depression, social isolation, and low quality of life and increased risk of death.
Muscle dysfunction in these patients contributes, together with dynamic hyperinflation, to the increase of fatigue and dyspnea during exercise, leading to the early cessation of effort and the decrease of maximum aerobic capacity. In patients with CRF, the increase of arterial oxygenation could have a beneficial result through the direct inhibition of the stimulation of the carotid body receptors by reducing ventilation and respiratory rate.
The increase in arterial oxygenation could also promote the increase in muscle oxygenation by i) reducing the production of lactates during efforts at iso-work and ii) increasing the pulmonary vasodilation and consequently the cardiac output and therefore oxygen delivery to the exercising muscle. Interestingly, the increase in muscle oxygenation is likely delaying the onset of diaphragm fatigue.
In the clinical setting, studies have shown the acute administration of oxygen to be useful in reducing the ventilatory demand of the COPD patient by reducing minute ventilation and respiratory rate and improving exercise tolerance. In COPD patients with and without chronic respiratory failure, acute oxygen administration appears to improve endurance capacity, maximal exercise capacity, dyspnea, and minute ventilation. In patients with moderate/severe non-hypoxic COPD at rest and during exercise, training with oxygen supplementation provides greater benefit to exercise tolerance and respiratory pattern. Instead, in patients with normoxia at rest and exercise-induced desaturation, the exercise tolerance evaluated with the six-minute walking test progressively improves with the addition of oxygen, although there is enormous variability within the individual groups.
In this population, the addition of oxygen during exercise leads to marginal effects linked only to a slight benefit on dyspnea. Therefore, to date, this treatment regimen only aims at patients with exercise-induced desaturation with associated severe dyspnea. Therefore, there is little support from the literature in offering oxygen therapy extensively during physical training to patients with COPD. Besides, there is a lack of solid studies that lead to firm conclusions on the use of oxygen therapy with particular reference to the benefits on functional outcomes, symptoms and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PaO2 in room air less than 60 mmHg assessed by arterial blood gas analysis
- •FEV1/FVC <70%
- •FEV1 < 50% of predicted
- •need for LTOT for 3 months
- •important non-comorbidities
排除标准
- •Presence of lung diseases other than COPD, respiratory tract infections in the last 4 weeks, terminality, severe neurological and cardiologic comorbidities.
结局指标
主要结局
Change of maximal voluntary activation (VA)
时间窗: baseline, 6 , 12 and 22 seconds
Evaluation of the electrically stimulated resting force (Qtpot) and of the maximum voluntary activation (MVA). The electrical stimulation used will consist of single square wave pulses of 0.1 ms duration, delivered by a constant current stimulator (DS7AH, Digitimer). The intensity of the stimulus used will be defined as follows: the current will be progressively increased from 0 mA to the value beyond which there will be no further increase in force and the amplitude of the M wave. The stimulus used for the study will be set at 125% of the intensity required to produce a maximum M wave response. Voluntary activation (VA) was then assessed using the interpolated twitch technique by comparing the force produced during a superimposed twitch on the MVC with the potentiated single twitch delivered 2-s afterwards. %VA = (1 - superimposed twitch force / Qtw,pot) · 100
Change of Rate of Perceived Exertion RPE
时间窗: baseline, 6 , 12 and 22 seconds
Assess subjective perception of muscle exertion (peripheral fatigue) and breathing effort (dyspnea). It will be used on scales from 1 to 10.
Change of the isometric force
时间窗: baseline, 6 , 12 and 22 seconds
Assessment maximal isometric contractions (MVC) pre, at midway through the fatigue protocol, post fatigue protocol and after 10' of rest after the fatigue protocol. Maximum force reduction expressed in Newtons will be analyzed. Subjects will be seated upright with back support. The hip and knee will be flexed to 90° and the force will be measured by a force transducer.
Change muscle electromyography
时间窗: baseline, 6 , 12 and 22 seconds
The M wave will be collected from the vastus lateralis after supramaximal electrical stimulation.The intensity of the stimulus used will be defined as follows: the current will be increased progressively from 0 mA to the value beyond which there will be no further increase in the amplitude of the M wave The stimulus used for the study will be set at 125% of the intensity required to produce a maximum M wave response.
次要结局
- Electromyographic evaluation during fatiguing protocol(up to 12 seconds)
- Monitoring muscle oxygenation(up to 12 seconds)
- Vascular function with sPLM(baseline)
