Effect of Oxygen in Normoxaemic COPD Patients Who Desaturate During Exercise

Study Overview
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Brief Summary
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In COPD patients with desaturation during exercise, several studies have shown an acute beneficial effect of supplemental oxygen. Therefore, both the British Thoracic Society and the American Thoracic Society guidelines recommend supplemental oxygen to patients who desaturate >4% and to below 88-90%. However, long-term studies have not been able to support this intervention. In this study of COPD patients, who desaturate and participate in a 7-week pulmonary rehabilitation programme, we examine the effect of supplemental oxygen on exercise tolerance, health status, and exacerbation rates. In a randomised design patients trained either with room air or with 2 litres oxygen per minute from a portable oxygen concentrator. All patients were asked to exercise every day for 30 minutes.

Detailed Description
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In COPD patients with desaturation during exercise, several studies have shown an acute beneficial effect of supplemental oxygen. Therefore, both the British Thoracic Society and the American Thoracic Society guidelines recommend supplemental oxygen to patients who desaturate >4% and to below 88-90%. However, long-term studies have not been able to support this intervention. In this study of COPD patients, who desaturate and participate in a 7-week pulmonary rehabilitation programme, we examine the effect of supplemental oxygen. Using a randomised design, patients trained either with room air (control) or with 2 litres oxygen per minute from a portable oxygen concentrator. All patients were asked to exercise every day for 30 minutes. Primary effect parameters: endurance shuttle walk time at baseline, 7 weeks (after intensive supervised rehabilitation), 3 months (after maintenance training twice a month), and after 6 months. Secondary effect parameters: St. George Respiratory Questionnaire (health status); usage of oxygen, exacerbations requiring medical treatment, hospitalisation and mortality in the same periods.

Official Title
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Effect of Ambulatory Oxygen in Normoxaemic COPD Patients Who Desaturate During Exercise. A Randomised Placebo Controlled Trial of Patients Who Participate in Pulmonary Rehabilitation

Conditions
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COPD

Intervention / Treatment
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* Other: oxygen from a portable concentrator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COPD participate in a 7-weeks pulmonary rehabilitation programme desaturate >4% to less than 90% during endurance shuttle walk test Exclusion Criteria: long-term oxygen therapy

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| No Intervention: 2<br>Rehabilitation, no supplemental oxygen | |
| Experimental: 1<br>Rehabilitation plus supplemental oxygen | Other: oxygen from a portable concentrator<br>* 2 l/minute during exercise<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shuttle walk (endurance time) |  | 7 week, 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| St. George Respiratory Questionnaire |  | 7 week, 3 and 6 months | 
| Usage of oxygen concentrator (Spent time according to the meter) |  | 7 weeks, 3 and 6 months | 
| Exacerbations requiring medical treatment (prednisolone or antibiotics) |  | 7 weeks, 3 and 6 months | 
| Hospitalisation |  | 7 weeks, 3 and 6 months | 
| Mortality |  | 7 weeks, 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD oxygen, COPD rehabilitation, exercise