Clinical trial NCT00592033: Effect of Oxygen in Normoxaemic COPD Patients Who Desaturate During Exercise
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COPD
Keywords: COPD oxygen
COPD rehabilitation
exercise
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Danish Lung Association
First posted: 2008-01-11
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Shuttle walk (endurance time)
timeFrame: 7 week, 3 and 6 months
Secondary outcomes:
measure: St. George Respiratory Questionnaire
timeFrame: 7 week, 3 and 6 months
measure: Usage of oxygen concentrator (Spent time according to the meter)
timeFrame: 7 weeks, 3 and 6 months
measure: Exacerbations requiring medical treatment (prednisolone or antibiotics)
timeFrame: 7 weeks, 3 and 6 months
measure: Hospitalisation
timeFrame: 7 weeks, 3 and 6 months
measure: Mortality
timeFrame: 7 weeks, 3 and 6 months
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: University Hospital, Hvidovre, Cardio-pulmonary depart.
Study officials:
affiliation: Hvidovre Hospital, University hospital, Cardio-pulmonary depart.
name: Thomas J Ringbaek, doctor
role: PRINCIPAL_INVESTIGATOR
References: