A Phase 4 interventional study of oxygen from a portable concentrator in COPD, sponsored by Hvidovre University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-22.
Sponsored by Hvidovre University Hospital · Phase 4, Interventional, and Treatment
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.
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.
4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.
This study's enrollment of 45 is below the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Hvidovre University Hospital is the lead sponsor of 299 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
Rehabilitation, no supplemental oxygen
Rehabilitation plus supplemental oxygen
Other: oxygen from a portable concentrator
2 l/minute during exercise
Shuttle walk (endurance time)
Time frame: 7 week, 3 and 6 months
St. George Respiratory Questionnaire
Time frame: 7 week, 3 and 6 months
Usage of oxygen concentrator (Spent time according to the meter)
Time frame: 7 weeks, 3 and 6 months
Exacerbations requiring medical treatment (prednisolone or antibiotics)
Time frame: 7 weeks, 3 and 6 months
Hospitalisation
Time frame: 7 weeks, 3 and 6 months
Mortality
Time frame: 7 weeks, 3 and 6 months
The record gives a start of May 2007, a primary completion of Dec 2011 and a completion of Dec 2011. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →
Hvidovre University Hospital →