Effect of Oxygen in Normoxaemic COPD Patients Who Desaturate During Exercise

March 21, 2012 updated by: Thomas Ringbaek, Hvidovre University Hospital

Effect of Ambulatory Oxygen in Normoxaemic COPD Patients Who Desaturate During Exercise. A Randomised Placebo Controlled Trial of Patients Who Participate in Pulmonary Rehabilitation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark, 2650
        • University Hospital, Hvidovre, Cardio-pulmonary depart.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 2
Rehabilitation, no supplemental oxygen
Experimental: 1
Rehabilitation plus supplemental oxygen
Other: oxygen from a portable concentrator
2 l/minute during exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Shuttle walk (endurance time)
Time Frame: 7 week, 3 and 6 months
7 week, 3 and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
St. George Respiratory Questionnaire
Time Frame: 7 week, 3 and 6 months
7 week, 3 and 6 months
Usage of oxygen concentrator (Spent time according to the meter)
Time Frame: 7 weeks, 3 and 6 months
7 weeks, 3 and 6 months
Exacerbations requiring medical treatment (prednisolone or antibiotics)
Time Frame: 7 weeks, 3 and 6 months
7 weeks, 3 and 6 months
Hospitalisation
Time Frame: 7 weeks, 3 and 6 months
7 weeks, 3 and 6 months
Mortality
Time Frame: 7 weeks, 3 and 6 months
7 weeks, 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Collaborators

Danish Lung Association

Investigators

  • Principal Investigator: Thomas J Ringbaek, doctor, Hvidovre Hospital, University hospital, Cardio-pulmonary depart.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

December 31, 2007

First Submitted That Met QC Criteria

December 31, 2007

First Posted (Estimate)

January 11, 2008

Study Record Updates

Last Update Posted (Estimate)

March 22, 2012

Last Update Submitted That Met QC Criteria

March 21, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-41-0569

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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