Effect of Oxygen in Normoxaemic COPD Patients Who Desaturate During Exercise

NCT ID: NCT00592033

Last Updated: 2012-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2011-12-31

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.

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2

Rehabilitation, no supplemental oxygen

Group Type: NO_INTERVENTION

No interventions assigned to this group

1

Rehabilitation plus supplemental oxygen

Group Type: EXPERIMENTAL

oxygen from a portable concentrator

Intervention Type: OTHER

2 l/minute during exercise

Interventions

oxygen from a portable concentrator

2 l/minute during exercise

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Danish Lung Association

OTHER

Sponsor Role: collaborator

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Thomas Ringbaek

Senior Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas J Ringbaek, doctor

Role: PRINCIPAL_INVESTIGATOR

Hvidovre Hospital, University hospital, Cardio-pulmonary depart.

Locations

University Hospital, Hvidovre, Cardio-pulmonary depart.

Hvidovre, , Denmark

Countries

Denmark

Other Identifiers

2007-41-0569

Identifier Type: -

Identifier Source: org_study_id