Effect of Oxygen in Normoxaemic COPD Patients Who Desaturate During Exercise

Phase 4

Completed

• Conditions: COPD
• Interventions: Other: oxygen from a portable concentrator

• Registration Number: NCT00592033
• Lead Sponsor: Hvidovre University Hospital

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.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-12-31
• Study First Submitted QC: 2007-12-31
• Study First Posted: 2008-01-11
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-21
• Last Update Posted: 2012-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	oxygen from a portable concentrator	Rehabilitation plus supplemental oxygen

Primary Outcome Measures

Name	Time	Method
Shuttle walk (endurance time)	7 week, 3 and 6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital, Hvidovre, Cardio-pulmonary depart.; 🇩🇰 Hvidovre, Denmark