Effect of Oxygen in Normoxaemic COPD Patients Who Desaturate During Exercise
Primary Purpose
COPD
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
oxygen from a portable concentrator
Sponsored by
About this trial
This is an interventional treatment trial for COPD focused on measuring COPD oxygen, COPD rehabilitation, exercise
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
Sites / Locations
- University Hospital, Hvidovre, Cardio-pulmonary depart.
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
2
1
Arm Description
Rehabilitation, no supplemental oxygen
Rehabilitation plus supplemental oxygen
Outcomes
Primary Outcome Measures
Shuttle walk (endurance time)
Secondary Outcome Measures
St. George Respiratory Questionnaire
Usage of oxygen concentrator (Spent time according to the meter)
Exacerbations requiring medical treatment (prednisolone or antibiotics)
Hospitalisation
Mortality
Full Information
NCT ID
NCT00592033
First Posted
December 31, 2007
Last Updated
March 21, 2012
Sponsor
Hvidovre University Hospital
Collaborators
Danish Lung Association
1. Study Identification
Unique Protocol Identification Number
NCT00592033
Brief Title
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
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
Collaborators
Danish Lung Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
Keywords
COPD oxygen, COPD rehabilitation, exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
No Intervention
Arm Description
Rehabilitation, no supplemental oxygen
Arm Title
1
Arm Type
Experimental
Arm Description
Rehabilitation plus supplemental oxygen
Intervention Type
Other
Intervention Name(s)
oxygen from a portable concentrator
Intervention Description
2 l/minute during exercise
Primary Outcome Measure Information:
Title
Shuttle walk (endurance time)
Time Frame
7 week, 3 and 6 months
Secondary Outcome Measure Information:
Title
St. George Respiratory Questionnaire
Time Frame
7 week, 3 and 6 months
Title
Usage of oxygen concentrator (Spent time according to the meter)
Time Frame
7 weeks, 3 and 6 months
Title
Exacerbations requiring medical treatment (prednisolone or antibiotics)
Time Frame
7 weeks, 3 and 6 months
Title
Hospitalisation
Time Frame
7 weeks, 3 and 6 months
Title
Mortality
Time Frame
7 weeks, 3 and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas J Ringbaek, doctor
Organizational Affiliation
Hvidovre Hospital, University hospital, Cardio-pulmonary depart.
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Hvidovre, Cardio-pulmonary depart.
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
12. IPD Sharing Statement
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Effect of Oxygen in Normoxaemic COPD Patients Who Desaturate During Exercise
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