search
Back to results

Nasal High Flow to Maintain the Benefits of Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease Patients (PPR-NHF)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Nasal high flow
Sponsored by
ADIR Association
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic obstructive pulmonary disease, Pulmonary rehabilitation, Nasal high flow

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • ADIR AssociationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nasal high flow

Usual care

Arm Description

Following baseline assessment, patients randomized to the nasal high flow arm will be equipped with a nasal high flow device (myAIRVO2) administrated through the Optiflow nasal canula. Flow will be set at the highest flow tolerated (20-30 L/min): initially 30 L/min, progressively decrease if not tolerated. Temperature will be set between 34-37°C according to the tolerance : initially 37°C and decreased if not tolerated. Patients will be asked to use the device 8h per day. Patients under long-term oxygen will preserve their usual flow. The usual prescribed oxygen flow will then be titrated during nasal high flow to maintain the same baseline transcutaneous oxygen saturation as their conventional oxygen therapy (≥ 90%) to prevent any oxygen dilution effect of nasal high flow.

Patient randomized to the control group will have no other specific intervention than their usual care. Patients under long-term oxygen will preserve their usual flow.

Outcomes

Primary Outcome Measures

Endurance capacity
Patients will perform a constant workload exercise testing at 75% of the maximal workload achieved during the incremental cardiopulmonary exercise testing.
Endurance capacity
Patients will perform a constant workload exercise testing at 75% of the maximal workload achieved during the incremental cardiopulmonary exercise testing.

Secondary Outcome Measures

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).
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).
Quality of life: Chronic Obstructive Pulmonary Disease Assessement Test
Quality of life will be assessed using the Chronic Obstructive Pulmonary Disease Assessement Test
Quality of life: Chronic Obstructive Pulmonary Disease Assessement Test
Quality of life will be assessed using the Chronic Obstructive Pulmonary Disease Assessement Test
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.
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.
Muscle function (1) : quadriceps muscle (rectus femoris) cross-sectional area
The quadriceps muscle thickness will be assessed using echographies.
Muscle function (1) : quadriceps muscle (rectus femoris) cross-sectional area
The quadriceps muscle thickness will be assessed using echographies.
Muscle function (2) : bioimpedance
The overall muscle function will be assessed using bioimpedance (free fat mass minus total body water)
Exercise capacity
Exercise capacity will be assessed using the six minutes walk test distance.
Exercise capacity
Exercise capacity will be assessed using the six minutes walk test distance.
Respiratory muscle function (1) : maximal inspiratory pressure
Respiratory muscle function (1) : maximal inspiratory pressure
Respiratory muscle function (2) : maximal expiratory pressure
Respiratory muscle function (2) : maximal expiratory pressure
Respiratory muscle function (3) : sniff test
Respiratory muscle function (3) : sniff test
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
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).
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.
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.
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
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
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).
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).
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).
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).
Adherence to treatment : days of utilization during the follow-up
The data will be retrieved from the nasal high flow device
Adherence to treatment : hours of utilization per day
The data will be retrieved from the nasal high flow device

Full Information

First Posted
March 18, 2019
Last Updated
March 16, 2022
Sponsor
ADIR Association
search

1. Study Identification

Unique Protocol Identification Number
NCT03882372
Brief Title
Nasal High Flow to Maintain the Benefits of Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 22, 2019 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ADIR Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic obstructive pulmonary disease, Pulmonary rehabilitation, Nasal high flow

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single blind randomized study.
Masking
Outcomes Assessor
Masking Description
Assessors will be unaware of the patient's allocation.
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nasal high flow
Arm Type
Experimental
Arm Description
Following baseline assessment, patients randomized to the nasal high flow arm will be equipped with a nasal high flow device (myAIRVO2) administrated through the Optiflow nasal canula. Flow will be set at the highest flow tolerated (20-30 L/min): initially 30 L/min, progressively decrease if not tolerated. Temperature will be set between 34-37°C according to the tolerance : initially 37°C and decreased if not tolerated. Patients will be asked to use the device 8h per day. Patients under long-term oxygen will preserve their usual flow. The usual prescribed oxygen flow will then be titrated during nasal high flow to maintain the same baseline transcutaneous oxygen saturation as their conventional oxygen therapy (≥ 90%) to prevent any oxygen dilution effect of nasal high flow.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Patient randomized to the control group will have no other specific intervention than their usual care. Patients under long-term oxygen will preserve their usual flow.
Intervention Type
Device
Intervention Name(s)
Nasal high flow
Intervention Description
See arm description.
Primary Outcome Measure Information:
Title
Endurance capacity
Description
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
Title
Endurance capacity
Description
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)
Secondary Outcome Measure Information:
Title
Quality of life: Saint George's Respiratory Questionnaire
Description
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
Title
Quality of life: Saint George's Respiratory Questionnaire
Description
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)
Title
Quality of life: Chronic Obstructive Pulmonary Disease Assessement Test
Description
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
Title
Quality of life: Chronic Obstructive Pulmonary Disease Assessement Test
Description
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)
Title
Exacerbations
Description
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
Title
Hospitalizations
Description
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
Title
Muscle function (1) : quadriceps muscle (rectus femoris) cross-sectional area
Description
The quadriceps muscle thickness will be assessed using echographies.
Time Frame
The quadriceps muscle thickness will be assessed at baseline
Title
Muscle function (1) : quadriceps muscle (rectus femoris) cross-sectional area
Description
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
Title
Muscle function (2) : bioimpedance
Description
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)
Title
Exercise capacity
Description
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
Title
Exercise capacity
Description
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)
Title
Respiratory muscle function (1) : maximal inspiratory pressure
Time Frame
Maximal inspiratory pressure will be assessed at baseline
Title
Respiratory muscle function (1) : maximal inspiratory pressure
Time Frame
Maximal inspiratory pressure will be assessed post-intervention (after 6months)
Title
Respiratory muscle function (2) : maximal expiratory pressure
Time Frame
Maximal expiratory pressure will be assessed at baseline
Title
Respiratory muscle function (2) : maximal expiratory pressure
Time Frame
Maximal expiratory pressure will be assessed post-intervention (after 6months)
Title
Respiratory muscle function (3) : sniff test
Time Frame
Sniff test will be assessed at baseline
Title
Respiratory muscle function (3) : sniff test
Time Frame
Sniff test will be assessed post-intervention (after 6months)
Title
Parasternal electromyogram
Description
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
Title
Parasternal electromyogram
Description
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)
Title
Physical activity (1) : steps per day
Description
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
Title
Physical activity (1) : steps per day
Description
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
Title
Physical activity (2) : time spent during activities superior to 3 metabolic equivalent per day
Description
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
Title
Physical activity (2) : time spent during activities superior to 3 metabolic equivalent per day
Description
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
Title
Quality of sleep (1) : Visual Analogue Scale
Description
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
Title
Quality of sleep (1) : Visual Analogue Scale
Description
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)
Title
Quality of sleep (2) : pittsburgh scale
Description
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
Title
Quality of sleep (2) : pittsburgh scale
Description
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)
Title
Adherence to treatment : days of utilization during the follow-up
Description
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
Title
Adherence to treatment : hours of utilization per day
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tristan Bonnevie, Msc
Phone
0235592970
Ext
+33
Email
rehabilitation@adir-hautenormandie.com
First Name & Middle Initial & Last Name or Official Title & Degree
Francis-Edouard Gravier, Msc
Phone
0235592970
Ext
+33
Email
kine@adir-hautenormandie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine Cuvelier, MD, PhD, Prof
Organizational Affiliation
Normandie University, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, France ; Pulmonary, Thoracic Oncology and Respiratory Intensive Care Department, Rouen University Hospital, Rouen, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean-François Muir, MD, Prof
Organizational Affiliation
ADIR Association, Rouen University Hospital, Rouen, France ; Normandie University, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, France
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maxime Patout, MD, Msc
Organizational Affiliation
Normandie University, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, France ; Pulmonary, Thoracic Oncology and Respiratory Intensive Care Department, Rouen University Hospital, Rouen, France
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tristan Bonnevie, Msc
Organizational Affiliation
ADIR Association, Rouen University Hospital, Rouen, France ; Normandie University, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, France
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Francis-Edouard Gravier, Msc
Organizational Affiliation
ADIR Association, Rouen University Hospital, Rouen, France ; Normandie University, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, France ; Pulmonary, Thoracic Oncology and Respiratory I
Official's Role
Study Chair
Facility Information:
Facility Name
ADIR Association
City
Bois-Guillaume
ZIP/Postal Code
76230
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tristan Bonnevie, Msc
Phone
0235592970
Ext
+33
Email
rehabilitation@adir-hautenormandie.com
First Name & Middle Initial & Last Name & Degree
Francis-Edouard Gravier, Msc
Phone
0235592970
Ext
+33
Email
kine@adir-hautenormandie.com
First Name & Middle Initial & Last Name & Degree
Antoine Cuvelier, MD, PhD, Prof
First Name & Middle Initial & Last Name & Degree
Jean-François Muir, MD, Prof
First Name & Middle Initial & Last Name & Degree
Maxime Patout, MD, Msc
First Name & Middle Initial & Last Name & Degree
Tristan Bonnevie, Msc
First Name & Middle Initial & Last Name & Degree
Francis-Edouard Gravier, Msc

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs