Chronic obstructive pulmonary disease (COPD) is a major cause of disability and mortality worldwide. This systemic disease progressively leads to dyspnea and exercise capacity impairment. Pulmonary rehabilitation effectively improves exercise capacity, dyspnea and quality of life in patients with COPD. However, its benefits progressively fade over time due to several factors such as the lack of regular exercise activity, dyspnea, airway secretions, hematosis impairment and acute exacerbations which can lead to hospitalization and accelerated muscle wasting. Nasal high flow (NHF) is a support used to deliver heated and humidified high flow air (up to 60 L/min) through nasal canula providing promising physiological benefits such as positive airway pressure or upper airway carbon dioxide washout. It can be used in association with oxygen and offers the advantage to overtake the patient's inspiratory flow, providing a stable inspired fraction of oxygen. Nasal high flow has widely been studied in pediatric and adult intensive care units and seems better than conventional oxygen therapy and as effective as noninvasive ventilation with regards to mortality to treat hypoxemic acute respiratory failure. More recently, several studies have shown that long-term nasal high flow could contribute to improve exercise capacity, dyspnea, airway secretion removal, hematosis, reduced acute exacerbations and subsequent hospitalizations in patients with COPD. Based on these results, the primary aim of this study is to assess whether long-term nasal high flow treatment can help COPD patients to better maintain their endurance capacity following a course of pulmonary rehabilitation.
Experimental design: Patients achieving their last pulmonary rehabilitation session will be approached to participate in this study. Eligible patients who agree to participate in the study and sign informed consent will perform two baseline visit assessments: First visit: Incremental cardiopulmonary exercise testing. Second visit: Other baseline assessment (see outcome section), including a constant workload exercise testing at 75% of the maximal workload achieved during the incremental exercise testing. Then, patients will then be randomized to one of the following two arms: * Nasal high flow, * Usual care. After 6 months, patients will be invited to perform the same assessment as during the second baseline visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
2
See arm description.
ADIR Association
Bois-Guillaume, France
Endurance capacity
Patients will perform a constant workload exercise testing at 75% of the maximal workload achieved during the incremental cardiopulmonary exercise testing.
Time frame: The endurance capacity will be assessed at baseline
Endurance capacity
Patients will perform a constant workload exercise testing at 75% of the maximal workload achieved during the incremental cardiopulmonary exercise testing.
Time frame: The endurance capacity will be assessed post-intervention (after 6months)
Quality of life: Saint George's Respiratory Questionnaire
Quality of life will be assessed using the Saint George's Respiratory Questionnaire. The score range from 0 (worst quality of life) to 100 (optimal quality of life).
Time frame: The quality of life will be assessed at baseline
Quality of life: Saint George's Respiratory Questionnaire
Quality of life will be assessed using the Saint George's Respiratory Questionnaire. The score range from 0 (worst quality of life) to 100 (optimal quality of life).
Time frame: The quality of life will be assessed at post-intervention (after 6months)
Quality of life: Chronic Obstructive Pulmonary Disease Assessement Test
Quality of life will be assessed using the Chronic Obstructive Pulmonary Disease Assessement Test
Time frame: The quality of life will be assessed at baseline and post-intervention for a total time frame of 6month
Quality of life: Chronic Obstructive Pulmonary Disease Assessement Test
Quality of life will be assessed using the Chronic Obstructive Pulmonary Disease Assessement Test
Time frame: The quality of life will be assessed post-intervention (after 6months)
Exacerbations
The number of chronic obstructive pulmonary disease self reported exacerbations experienced by the participants during the 6 months period of follow-up will be assessed.
Time frame: The number of exacerbations will be assessed for a total time frame of 6month
Hospitalizations
The number of chronic obstructive pulmonary disease related hospitalizations experienced by the participants during the 6 months period of follow-up will be assessed.
Time frame: The number of hospitalizations will be assessed for a total time frame of 6month
Muscle function (1) : quadriceps muscle (rectus femoris) cross-sectional area
The quadriceps muscle thickness will be assessed using echographies.
Time frame: The quadriceps muscle thickness will be assessed at baseline
Muscle function (1) : quadriceps muscle (rectus femoris) cross-sectional area
The quadriceps muscle thickness will be assessed using echographies.
Time frame: The quadriceps muscle thickness will be assessed at baseline and post-intervention for a total time frame of 6month
Muscle function (2) : bioimpedance
The overall muscle function will be assessed using bioimpedance (free fat mass minus total body water)
Time frame: The overall muscle function using bioimpedance will be assessed post-intervention (after 6months)
Exercise capacity
Exercise capacity will be assessed using the six minutes walk test distance.
Time frame: The distance performed during the six-minute walk test will be assessed at baseline
Exercise capacity
Exercise capacity will be assessed using the six minutes walk test distance.
Time frame: The distance performed during the six-minute walk test will be assessed post-intervention (after 6months)
Respiratory muscle function (1) : maximal inspiratory pressure
Time frame: Maximal inspiratory pressure will be assessed at baseline
Respiratory muscle function (1) : maximal inspiratory pressure
Time frame: Maximal inspiratory pressure will be assessed post-intervention (after 6months)
Respiratory muscle function (2) : maximal expiratory pressure
Time frame: Maximal expiratory pressure will be assessed at baseline
Respiratory muscle function (2) : maximal expiratory pressure
Time frame: Maximal expiratory pressure will be assessed post-intervention (after 6months)
Respiratory muscle function (3) : sniff test
Time frame: Sniff test will be assessed at baseline
Respiratory muscle function (3) : sniff test
Time frame: Sniff test will be assessed post-intervention (after 6months)
Parasternal electromyogram
Parasternal electromyogram will be used to assess central output during maximal inspiratory and expiratory pressure measurement as during the sniff test. Moreover, parasternal electromyogram will be assessed both at rest and during nasal high flow (30L/min, 34°C).
Time frame: Parasternal electromyogram will be assessed at baseline
Parasternal electromyogram
Parasternal electromyogram will be used to assess central output during maximal inspiratory and expiratory pressure measurement as during the sniff test. Moreover, parasternal electromyogram will be assessed both at rest and during nasal high flow (30L/min, 34°C).
Time frame: Parasternal electromyogram will be assessed post-intervention (after 6months)
Physical activity (1) : steps per day
The number of steps per day will be recorded over a course of 14 week days using an activity monitor.
Time frame: Steps per day will be assessed during 14 days following inclusion
Physical activity (1) : steps per day
The number of steps per day will be recorded over a course of 14 week days using an activity monitor.
Time frame: Steps per day will be assessed during 14 days after 6months of intervention
Physical activity (2) : time spent during activities superior to 3 metabolic equivalent per day
The time spent during activities superior to 3 metabolic equivalent per day will be over a course of 14 week days
Time frame: The time spent during activities superior to 3 metabolic equivalent per day will be assessed 14 days following inclusion
Physical activity (2) : time spent during activities superior to 3 metabolic equivalent per day
The time spent during activities superior to 3 metabolic equivalent per day will be over a course of 14 week days
Time frame: The time spent during activities superior to 3 metabolic equivalent per day will be assessed during 14 days after 6months of intervention
Quality of sleep (1) : Visual Analogue Scale
The quality of sleep will be assessed using a aVisual Analogue Scale (ranging from 0 to 10 with 10 indicating higher sleep quality).
Time frame: The quality of sleep using a Visual Analogue Scale will be assessed at baseline
Quality of sleep (1) : Visual Analogue Scale
The quality of sleep will be assessed using a aVisual Analogue Scale (ranging from 0 to 10 with 10 indicating higher sleep quality).
Time frame: The quality of sleep using a Visual Analogue Scale will be assessed post-intervention (after 6months)
Quality of sleep (2) : pittsburgh scale
The quality of sleep will be assessed using the pittsburgh scale which has been validated to assess sleep quality. The scale range from 0 (major sleep difficulties) to 21 (no difficulty).
Time frame: The quality of sleep using the pittsburgh scale will be assessed at baseline
Quality of sleep (2) : pittsburgh scale
The quality of sleep will be assessed using the pittsburgh scale which has been validated to assess sleep quality. The scale range from 0 (major sleep difficulties) to 21 (no difficulty).
Time frame: The quality of sleep using the pittsburgh scale will be assessed post-intervention (after 6months)
Adherence to treatment : days of utilization during the follow-up
The data will be retrieved from the nasal high flow device
Time frame: The number of days that the nasal high flow device was used throughout the follow-up will be assessed post-intervention in the nasal high flow arm for a total time frame of 6 months
Adherence to treatment : hours of utilization per day
The data will be retrieved from the nasal high flow device
Time frame: The number of hours of utilization per day throughout the follow-up will be assessed post-intervention in the nasal high flow arm for a total time frame of 6 months
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