Nasal High Flow to Maintain the Benefits of Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease Patients

Chronic Obstructive Pulmonary Disease Clinical Trial

— PPR-NHF  

Official title:

Nasal High Flow to Maintain the Benefits of Pulmonary Rehabilitation in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease - A Randomized Controlled Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03882372
• Other study ID #: PPR-NHF
• Status: Terminated
• Phase: N/A
• Start date: July 22, 2019
• Est. completion date: September 1, 2023

Study information

• Verified date: November 2023
• Source: ADIR Association
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Chronic obstructive pulmonary disease stage III to IV;
• With or without long-term oxygen therapy;
• Having completed a course of pulmonary rehabilitation within the last 4 weeks (at least 18 sessions).

Exclusion Criteria:

• Did not complete a course of pulmonary rehabilitation;
• Using noninvasive ventilation or constant positive airway pressure treatment;
• Tracheostomy;
• Nasal high flow intolerance;
• Pregnancy or likely to be;
• Unable to consent;
• Patients under guardianship.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Nasal high flow
See arm description.

Locations

Country	Name	City	State
France	ADIR Association	Bois-Guillaume

Sponsors (1)

Lead Sponsor	Collaborator
ADIR Association

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endurance capacity	Patients will perform a constant workload exercise testing at 75% of the maximal workload achieved during the incremental cardiopulmonary exercise testing.	The endurance capacity will be assessed at baseline
Primary	Endurance capacity	Patients will perform a constant workload exercise testing at 75% of the maximal workload achieved during the incremental cardiopulmonary exercise testing.	The endurance capacity will be assessed post-intervention (after 6months)
Secondary	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).	The quality of life will be assessed at baseline
Secondary	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).	The quality of life will be assessed at post-intervention (after 6months)
Secondary	Quality of life: Chronic Obstructive Pulmonary Disease Assessement Test	Quality of life will be assessed using the Chronic Obstructive Pulmonary Disease Assessement Test	The quality of life will be assessed at baseline and post-intervention for a total time frame of 6month
Secondary	Quality of life: Chronic Obstructive Pulmonary Disease Assessement Test	Quality of life will be assessed using the Chronic Obstructive Pulmonary Disease Assessement Test	The quality of life will be assessed post-intervention (after 6months)
Secondary	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.	The number of exacerbations will be assessed for a total time frame of 6month
Secondary	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.	The number of hospitalizations will be assessed for a total time frame of 6month
Secondary	Muscle function (1) : quadriceps muscle (rectus femoris) cross-sectional area	The quadriceps muscle thickness will be assessed using echographies.	The quadriceps muscle thickness will be assessed at baseline
Secondary	Muscle function (1) : quadriceps muscle (rectus femoris) cross-sectional area	The quadriceps muscle thickness will be assessed using echographies.	The quadriceps muscle thickness will be assessed at baseline and post-intervention for a total time frame of 6month
Secondary	Muscle function (2) : bioimpedance	The overall muscle function will be assessed using bioimpedance (free fat mass minus total body water)	The overall muscle function using bioimpedance will be assessed post-intervention (after 6months)
Secondary	Exercise capacity	Exercise capacity will be assessed using the six minutes walk test distance.	The distance performed during the six-minute walk test will be assessed at baseline
Secondary	Exercise capacity	Exercise capacity will be assessed using the six minutes walk test distance.	The distance performed during the six-minute walk test will be assessed post-intervention (after 6months)
Secondary	Respiratory muscle function (1) : maximal inspiratory pressure		Maximal inspiratory pressure will be assessed at baseline
Secondary	Respiratory muscle function (1) : maximal inspiratory pressure		Maximal inspiratory pressure will be assessed post-intervention (after 6months)
Secondary	Respiratory muscle function (2) : maximal expiratory pressure		Maximal expiratory pressure will be assessed at baseline
Secondary	Respiratory muscle function (2) : maximal expiratory pressure		Maximal expiratory pressure will be assessed post-intervention (after 6months)
Secondary	Respiratory muscle function (3) : sniff test		Sniff test will be assessed at baseline
Secondary	Respiratory muscle function (3) : sniff test		Sniff test will be assessed post-intervention (after 6months)
Secondary	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).	Parasternal electromyogram will be assessed at baseline
Secondary	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).	Parasternal electromyogram will be assessed post-intervention (after 6months)
Secondary	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.	Steps per day will be assessed during 14 days following inclusion
Secondary	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.	Steps per day will be assessed during 14 days after 6months of intervention
Secondary	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	The time spent during activities superior to 3 metabolic equivalent per day will be assessed 14 days following inclusion
Secondary	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	The time spent during activities superior to 3 metabolic equivalent per day will be assessed during 14 days after 6months of intervention
Secondary	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).	The quality of sleep using a Visual Analogue Scale will be assessed at baseline
Secondary	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).	The quality of sleep using a Visual Analogue Scale will be assessed post-intervention (after 6months)
Secondary	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).	The quality of sleep using the pittsburgh scale will be assessed at baseline
Secondary	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).	The quality of sleep using the pittsburgh scale will be assessed post-intervention (after 6months)
Secondary	Adherence to treatment : days of utilization during the follow-up	The data will be retrieved from the nasal high flow device	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
Secondary	Adherence to treatment : hours of utilization per day	The data will be retrieved from the nasal high flow device	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