The Efficacy of Nasal High Flow Oxygen Therapy With Rehabilitation in the Patients With Chronic Respiratory Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the exercise endurance between oxygen therapy with rehabilitation and nasal high flow therapy with rehabilitation for the patients with chronic respiratory failure receiving long-term oxygen therapy.

Detailed Description
-----------------
In patients with chronic respiratory failure, pulmonary rehabilitation is recognized as an evidence-based treatment in improving exercise capacity, muscle strength, dyspnea, and quality of life. Oxygen supplementation during exercise induced dose-dependent improvement in endurance and symptom perception in chronic obstructive pulmonary disease patients. Recently, nasal high flow therapy which consists of high flow gas with an FiO2 ranging from 0.21 to nearly 1.0 adjusted by an oxygen blender, brought to body temperature, and saturated with water through an in-line humidifier is available. The present study is randomised to compare the effect of exercise endurance between oxygen therapy with rehabilitation and nasal high flow therapy with rehabilitation for the patients with chronic respiratory failure receiving long-term oxygen therapy.

Official Title
-----------------
The Efficacy of Nasal High Flow Oxygen Therapy With Rehabilitation in the Patients With Chronic Respiratory Failure

Conditions
-----------------
Chronic Respiratory Failure, Nasal High Flow Therapy, Rehabilitation, Exercise Endurance

Intervention / Treatment
-----------------
* Device: nasal high flow therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with chronic respiratory failure receiving long-term oxygen therapy for more than 3 months. Exclusion Criteria: Subjects with severe cardiovascular disease, diabetes, neurological disease, and renal failure. Subject who are unable to undergo rehabilitation.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: nasal high flow therapy<br>In this group, patients have undergone rehabilitation under the nasal high flow therapy (FiO2 100%, oxygen flow from 30 to 60 L/min) during four weeks. | Device: nasal high flow therapy<br>* The nasal high flow therapy has enabled high flow oxygen to be derived through nasal cannula. This mode not only allows constant FiO2 during peak inspiratory flow but also confers benefits including a low level of continuous positive airway pressure with increased end-expiratory lung volume and reduced work of breathing, partly through intrinsic positive end-expiration pressure compensation and dead space washout. The inspired gases are warmed and humidified, improving comfort and possibly reducing airway inflammation, leading to improved drainage of respiratory secretions.<br>|
| No Intervention: oxygen therapy<br>In this group, patients have undergone rehabilitation under the oxygen therapy via a nasal canula (6 L/min) during four weeks. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walk distance (measured by six minutes walking test) |  | Four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six minutes walking test (minimum Oxygen Saturation of Arterial Blood Measured by Pulse Oximeter (SpO2) et.) |  | Four weeks | 
| Exercise tolerance test (exercise time et.) |  | Four weeks | 
| Body composition measured by InBody (muscle mass et.) |  | Four weeks | 
| Arterial blood gas |  | Four weeks | 
| Inflammation (CRP et.) |  | Four weeks | 
| Nutritional status (body mass index(kg/m2) et.) |  | Four weeks | 
| Sympathetic activity (Catecholamine et.) |  | Four weeks | 
| Dyspnea (Modified Borg scale) |  | Four weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nasal high flow therapy, rehabilitation, exercise endurance