Comparison of Clinical and Physiological Response Among Three Modalities of Exercise Training in COPD With Chronic Respiratory Failure (CRF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Changes in the maximal work load
研究概览
简要总结
Advanced Chronic Obstructive Pulmonary Disease (COPD) is a condition with a negative prognosis that causes symptoms such as wheezing and fatigue that dramatically reduce the quality of life of the person with the disease.
Typically, the advanced stage of COPD is characterized by a fluctuating pattern and recurrent hospitalizations, and by a vicious circle in which dyspnoea increases and exercise tolerance reduces, causing depression with social isolation, low quality of life and increased risk of death.
Muscle dysfunction in these patients contributes together with dynamic hyperinflation to increased fatigue and dyspnoea during exercise, leading to early interruption of exertion, before reaching the maximal aerobic capacity.
The European and American guidelines of the American Thoracic Society / European Respiratory Society relating to the patient with COPD emphasize the need for the patient to undergo Respiratory Rehabilitation (RR) programs. The RR should include training programs as they improve exercise capacity, dyspnoea and quality of life more than programs that do not include training.
To our knowledge, no study has been performed in COPD with chronic respiratory failure (CRF) patients to evaluate the effects of High Interval Training compared to continuous submaximal training. Moreover, no different interval training protocols have been compared. However, studies conducted on healthy subjects or on other pathologies, show how the interval training protocol induces, in a specific and diversified way, physiological modifications to the cardio-respiratory and muscular systems.
In COPD patients with respiratory failure with marked muscular dysfunction and associated systemic changes (systemic inflammation, vascular changes, pulmonary hypertension, right heart failure, etc.), the evaluation of the best training program would reinforce the rehabilitative indications not yet fully proposed in the Guidelines. Moreover, the evaluation of the response to different training stimuli could provide important information on the reversibility of the intolerance to the effort in this patient population.
Primary aim of this study will be to evaluate the physiological effects on exercise tolerance of three training modalities performed in an intra-hospital setting (classic endurance training compared to two high-intensity interval programs - Long Interval Training and Short Interval training) in a population of COPD patients with chronic hypoxemic respiratory failure.
详细描述
Advanced (Chronic Obstructive Pulmonary Disease) COPD is a condition with a negative prognosis that causes symptoms such as wheezing and fatigue that dramatically reduce the quality of life of the person with the disease.
Typically, the advanced stage of COPD is characterized by a fluctuating pattern and recurrent hospitalizations, and by a vicious circle in which dyspnoea increases and exercise tolerance reduces, which in turn causes depression and associated social isolation, low quality of life and increased risk of death.
Muscle dysfunction in these patients contributes together with dynamic hyperinflation to increased fatigue and dyspnoea during exercise, leading to early interruption of exertion, before reaching maximum aerobic capacity.
The European and American guidelines of the American Thoracic Society / European Respiratory Society relating to the patient with Chronic Obstructive Pulmonary Disease (COPD) emphasize the need for the patient to undergo Respiratory Rehabilitation (RR) programs. The RR should include training programs as they improve exercise capacity, dyspnoea and quality of life more than programs that do not include training.
However, although there are many studies referring to the benefits of physical exercise in patients with COPD with mild-to-moderate severity, the recent guidelines provide few recommendations for types of training and its efficacy for patients with advanced disease that have already developed Chronic Respiratory Failure (CRF) and use of Long Term Oxygen Therapy (LTOT).
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
- None
入排标准
- 年龄范围
- 51 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age> 50 years
- •clinical definition of COPD according to GOLD guidelines (10) with FEV1 / FVC G 70% and FEV1 <50% of the above
- •PaO2 in air-ambient lower than 60 mmHg evaluated through arterial blood gas analysis
- •oxygen therapy prescription for more than 18 hours/ day for at least one month
- •clinical stable condition
排除标准
- •presence of pulmonary diseases other than COPD
- •respiratory tract infections in the last 4 weeks
- •termination
结局指标
主要结局
Changes in the maximal work load
时间窗: at baseline and 1 month
Another way to evaluate changes in effort tolerance will be to evaluate the maximal work load (Watts max) that patients will achive during a cicloergometer incremental test.
Changes in walking distance
时间窗: at baseline, 1 month and 7 months
Another way to evaluate changes in effort tolerance will be to evaluate meters walked during a 6 minute walking test (6MWT).
Changes in effort tolerance
时间窗: at baseline, 1 month and 7 months
We will evaluate the time to exhaustion (Tlim) of a Constant Load Endurance Test (CLET) taht will be set at load corresponding to 80% of the Watts max achieved at the incremental cicloergometer test.
次要结局
- Patient's satisfaction: Likert scale(at 1 month)
- Percentage of drop out patients(at 1 month)
- Change in ADL performance(at baseline, 1 month and 7 months)
- Change in fatigue (physiological evaluation)(at baseline, 1 month and 7 months)
- Change in dyspnoea(at baseline, 1 month and 7 months)
- Changes in quadriceps volume(at baseline, 1 month and 7 months)
- Change in Balance(at 1 month and 7 months)
- Change in Endothelial function(at baseline, 1 month and 7 months)
- Change in fatigue (qualitative evaluation)(at baseline, 1 month and 7 months)
- Change in quality of life(at 1 month and 7 months)