Improving Outcomes of Respiratory Patients With Exertional Hypoxemia

Study Overview
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Brief Summary
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The primary aim of this pilot randomized controlled trial is to determine feasibility of the proposed pulmonary rehabilitation intervention.

Detailed Description
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In this pilot randomized controlled trial, our primary aim is to determine feasibility of the proposed intervention.

Official Title
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Improving Post-hospitalization Outcomes of Respiratory Patients With Exertional Hypoxemia by Early Pulmonary Rehabilitation Using High Flow Nasal Oxygen- a Pilot Randomized Controlled Trial.

Conditions
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Pulmonary Rehabilitation

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 21 years and above Presence of exertional hypoxemia during 1-minute sit-to-stand test diagnosis of acute COPD exacerbation or Covid-19 pneumonia or exacerbation of bronchiectasis or exacerbation of interstitial lung disease physically fit to participate in exercise therapy as determined by both the patient's physician and physiotherapist Exclusion Criteria: uncontrolled severe medical conditions currently enrolled in a pulmonary rehabilitation trial unsuitable for randomization as determined by the patient's physician

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 100 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 |
| --- | --- |
| Experimental: High flow oxygen<br>High flow nasal oxygen | Device: High flow oxygen<br>* Use of HFO<br>|
| Active Comparator: Usual care<br>room air or normal flow oxygen | Other: Usual care<br>* Room air or normal flow oxygen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in 1-minute sit to stand test | maximum number of sit to stand cycles in 1 minute | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in 30-second sit to stand test | maximum number of sit to stand cycles in 30 seconds | 1 month, 3 month | 
| Changes in respiratory symptoms | Modified Medical Research Council Dyspnea Scale. The scale ranges from 0 to 4 with a higher score indicating increasing breathlessness | 1 month, 3 months | 
| Changes in mood | Hospital Anxiety Depression Scale. The scale ranges from 0 to 21, A total subscale score of >8 points indicates considerable symptoms of anxiety or depression. | 1 month, 3 month | 
| changes in quality of life | EQ-5D-5L | 1 month, 3 month | 
| Changes in lung function | Forced expiratory volume in 1 sec | 1 month, 3 month | 
| Changes in lung function | forced vital capacity | 1 month, 3 month | 
| Proportion of patients who still have exertional hypoxemia | Comparing the proportion of patients who still have exertional hypoxemia | 1 month, 3 month | 
| Adherence rates | Comparing the adherence rates between the 2 study arms | 3 week | 
| Changes in 1-minute sit to stand test | maximum number of sit to stand cycles in 1 minute | 3 month |