Abstract
BackgroundThe benefit of pulmonary rehabilitation (PR) in symptomatic chronic obstructive pulmonary disease (COPD) is well known. However, advanced patients with chronic respiratory failure (CRF), a category excluded from most studies, are frequently unable to sustain a work-load sufficiently high to obtain the full benefit of PR on exercise tolerance. Recent studies involving heated and humidified high flow oxygen therapy (HFOT) showed positive effects on breathing pattern and ventilatory efficiency during effort. We thus plan to compare, in COPD patients with CRF undergoing a high-intensity exercise programme, the effect of using HFOT versus standard oxygen delivery via Venturi Mask (V-mask), at the same inspiratory oxygen fraction, on improving exercise endurance.Methods/DesignThis is a multicentre randomised controlled trial that will involve 156 COPD inpatients with CRF recruited from seven PR hospitals. Patients will be randomised to one of two groups – V-mask versus HFOT. All patients will undergo the same high-intensity exercise programme using either of the oxygen delivery devices as per their group allocation. Training will consist of 20 sessions, over 1 month (5 sessions per week) within the hospitalisation period. Anthropometric and clinical data, including body mass index, diagnosis, spirometry and comorbidities (Cumulative Rating Scale) will be collected at baseline. At baseline and at the end of the exercise programme (primary assessment time) evaluation will include exercise tolerance (Constant Work Rate Exercise Test) (primary outcome), functional capacity (6-min walk test), maximal inspiratory pressure/maximal expiratory pressure, peripheral muscle strength (biceps and quadriceps) by manual dynamometer, respiratory exchanges (blood gases analysis), disability (Barthel Index and Barthel Dyspnoea Index), impact of disease (COPD Assessment test), and quality of life (Maugeri Respiratory Failure Scale-26). At the end of the training period, patient satisfaction will be evaluated.DiscussionThis study will add knowledge about the exercise response in advanced COPD with CRF and verify if an alternative tool, namely HFOT, can increase the benefit obtained from PR.Trial registrationClinicalTrials.gov ID NET03322787Registered: 6 November 2017
Highlights
The benefit of pulmonary rehabilitation (PR) in symptomatic chronic obstructive pulmonary disease (COPD) is well known
This study will add knowledge about the exercise response in advanced COPD with chronic respiratory failure (CRF) and verify if an alternative tool, namely high flow oxygen therapy (HFOT), can increase the benefit obtained from PR
Primary aim The primary aim of the trial will be to test the effect of using High-flow nasal therapy (HFNT) compared to a standard oxygen therapy delivered by the Venturi-mask (V-mask) at the same inspiratory fraction of oxygen (FiO2) in severe COPD patients with CRF performing 20 sessions of exercise training
Summary
Chronic obstructive pulmonary disease (COPD) is a heterogeneous disorder characterised by dysfunction of the small and large airways as well as by destruction of the lung parenchyma in highly variable combinations [1]. Optimisation of drug therapy [11] along with nonpharmacological strategies can be useful to enhance exercise tolerance by reducing dyspnoea and work of breathing in advanced COPD with CRF. Among these techniques, oxygen supplementation delivered by nasal probes [12] and several different types of non-invasive ventilation (NIV) have been proposed [5]. Only one physiological cross-over study has shown that HFNT can increase exercise tolerance in patients with severe but stable COPD [17], but no clinical trials have investigated the effects of HFNT in a programme of exercise training for COPD with CRF. This new technique could be proposed to increase training to a wider range of patients
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