Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-11 @ 12:56 AM
Study NCT ID:
NCT00592033
Status:
COMPLETED
Last Update Posted:
2012-03-22
First Post:
2007-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Oxygen in Normoxaemic COPD Patients Who Desaturate During Exercise
Sponsor:
Hvidovre University Hospital
Organization:
Study Overview
Official Title:
Effect of Ambulatory Oxygen in Normoxaemic COPD Patients Who Desaturate During Exercise. A Randomised Placebo Controlled Trial of Patients Who Participate in Pulmonary Rehabilitation
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: