High Flow Nasal Oxygen Versus Usual Care in COPD Pulmonary Rehabiliation

Study Overview
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Brief Summary
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To compare the effects of high flow nasal oxygen with usual care during an outpatient 6-week pulmonary rehabilitation program after hospitalization for COPD exacerbation.

Detailed Description
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This is a pilot randomized controlled trial to compare the effects of high flow nasal oxygen with usual care during an outpatient 6-week pulmonary rehabilitation program after hospitalization for COPD exacerbation.

Official Title
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Comparing the Effect of High Flow Nasal Oxygen With Usual Care on Pulmonary Rehabilitation in COPD Patients After an Acute Exacerbation; a Pilot Randomized Controlled Trial

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: Usual care
* Other: High flow nasal oxygen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 21 years and above Known diagnosis of COPD based on history AND spirometry demonstrating post bronchodilator FEV1/FVC ratio <0.7 Currently admitted inpatient for an acute COPD exacerbation as the primary diagnosis Fit to participate in exercise therapy as determined by both physician and physiotherapist Has the mental capacity to follow instructions Experience shortness of breath on exertion Have decreased ability to carry out activities due to shortness of breath Willing to participate in the exercise program Exclusion Criteria: Uncontrolled/ unstable medical conditions such as severe chronic heart failure that make exercise unsafe Pulmonary disorder other than COPD Physical conditions that preclude the ability to participate in exercise or may impair exercise performance.

Ages Eligible for Study
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Minimum Age: 21 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care<br>Patients will under go usual care ( pulmonary rehabilitation on room air or with nasal oxygen supplementation) | Other: Usual care<br>* Usual Care<br>|
| Experimental: High flow nasal oxygen<br>Patients will undergo pulmonary rehabilitation with high flow nasal oxygen | Other: High flow nasal oxygen<br>* High flow nasal oxygen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-minute walk distance | It is the maximum distance walked in 6 minutes | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COPD Assessment Test score | Chronic obstructive pulmonary disease assessment test (CAT) score | 3 weeks, 6 weeks and 1 month after completion of program | 
| Hospital Anxiety Depression Scale | This scale has 2 subscale scores of 1) Depression 2) Anxiety. Scores of 0-7 = Normal, 8-10 = Borderline, 11-21 = Abnormal | 3 weeks, 6 weeks and 1 month after completion of program | 
| Respiratory function test | It is a test of respiratory function | 3 weeks, 6 weeks and 1 month after completion of program | 
| 6-minute walk distance | It is the maximum distance walked in 6 minutes | 3 weeks and 1 month after completion of program |