We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Oxygen in Normoxaemic COPD Patients Who Desaturate During Exercise

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00592033
First Posted: January 11, 2008
Last Update Posted: March 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Danish Lung Association
Information provided by (Responsible Party):
Thomas Ringbaek, Hvidovre University Hospital
  Purpose
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.

Condition Intervention Phase
COPD Other: oxygen from a portable concentrator Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Thomas Ringbaek, Hvidovre University Hospital:

Primary Outcome Measures:
  • Shuttle walk (endurance time) [ Time Frame: 7 week, 3 and 6 months ]

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

Enrollment: 45
Study Start Date: May 2007
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 2
Rehabilitation, no supplemental oxygen
Experimental: 1
Rehabilitation plus supplemental oxygen
Other: oxygen from a portable concentrator
2 l/minute during exercise

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00592033


Locations
Denmark
University Hospital, Hvidovre, Cardio-pulmonary depart.
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Danish Lung Association
Investigators
Principal Investigator: Thomas J Ringbaek, doctor Hvidovre Hospital, University hospital, Cardio-pulmonary depart.
  More Information

Responsible Party: Thomas Ringbaek, Senior Consultant, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT00592033     History of Changes
Other Study ID Numbers: 2007-41-0569
First Submitted: December 31, 2007
First Posted: January 11, 2008
Last Update Posted: March 22, 2012
Last Verified: March 2012

Keywords provided by Thomas Ringbaek, Hvidovre University Hospital:
COPD oxygen
COPD rehabilitation
exercise