Study on Optimal Oxygen Concentration During Pulmonary Rehabilitation

Study Overview
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Brief Summary
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The purpose of this study is to compare the exercise capacity between high SpO2 (Minimum SpO2 94-96%) value during pulmonary rehabilitation and low SpO2 (Minimum SpO2 84-86%) value during pulmonary rehabilitation for the patients with chronic respiratory failure receiving long-term oxygen therapy.

Detailed Description
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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. However, optimal SpO2 value during pulmonary rehabilitation in patients with chronic respiratory failure receiving long-term oxygen therapy is unclear. The present study is randomized to compare the effect of exercise capacity between high SpO2 (Minimum SpO2 94-96%) value during pulmonary rehabilitation and low SpO2 (Minimum SpO2 84-86%) value during pulmonary rehabilitation for the patients with chronic respiratory failure receiving long-term oxygen therapy.

Official Title
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Effect of Pulmonary Rehabilitation Under Different Oxygen Concentration Using High-flow Nasal Cannula

Conditions
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High-flow Nasal Cannula, Exercise Capacity, Chronic Respiratory Failure, Optimal SpO2 Value

Intervention / Treatment
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* Other: High-flow nasal cannula
* Other: Low SpO2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with chronic respiratory failure receiving long-term oxygen therapy for more than 3 months. Exclusion Criteria: Subjects with severe cardiovascular disease, liver disease, neurological disease, and renal failure. Subjects with a history of hospitalization for pneumonia or exacerbation of respiratory failure within the last month. Subjects with changes in LTOT prescription flow within the last month Subjects who cannot undergo pulmonary rehabilitation due to severe heart failure, arteriosclerosis obliterans or spinal disease.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High SpO2 group<br>In this group, patients have undergone 4 weeks of pulmonary rehabilitation under the HFNC (FIO2 value that the minimum SpO2 value during pulmonary rehabilitation is 94-96%, and a flow of 10 L/min). | Other: High-flow nasal cannula<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>|
| Active Comparator: Low SpO2 group<br>In this group, patients have undergone 4 weeks of pulmonary rehabilitation under the HFNC (FIO2 value that the minimum SpO2 value during pulmonary rehabilitation is 84-86%, and a flow of 10 L/min). | Other: Low SpO2<br>* Low SpO2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the six-minutes walking distance prior to and following 4 weeks of pulmonary rehabilitation |  | four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the six-minutes walking test (lowest SpO2 value etc.) prior to and following 4 weeks of pulmonary rehabilitation |  | four weeks | 
| Change in the constant-load exercise test (duration time etc.) prior to and following 4 weeks of pulmonary rehabilitation |  | four weeks | 
| Change in the incremental-exercise test (Maximum load value etc.) prior to and following 4 weeks of pulmonary rehabilitation |  | four weeks | 
| Change in the body composition measured by InBody (muscle mass et.) prior to and following 4 weeks of pulmonary rehabilitation |  | four weeks | 
| Change in the arterial blood gas (PaO2 value etc.) prior to and following 4 weeks of pulmonary rehabilitation |  | four weeks | 
| Change in the inflammation marker (CRP etc.) prior to and following 4 weeks of pulmonary rehabilitation |  | four weeks | 
| Change in the nutritional status (body mass index(kg/m2) et.) prior to and following 4 weeks of pulmonary rehabilitation |  | four weeks | 
| Change in the sympathetic activity (Plasma catecholamine et.) prior to and following 4 weeks of pulmonary rehabilitation |  | four weeks | 
| Change in the dyspnea (Modified Borg scale) prior to and following 4 weeks of pulmonary rehabilitation |  | four weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HFNC, 6MWD