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Effect of Oxygen in Normoxaemic COPD Patients Who Desaturate During Exercise

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00592033
Enrollment
45
Registered
2008-01-11
Start date
2007-05-31
Completion date
2011-12-31
Last updated
2012-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Keywords

COPD oxygen, COPD rehabilitation, exercise

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.

Interventions

OTHERoxygen from a portable concentrator

2 l/minute during exercise

Sponsors

Danish Lung Association
CollaboratorOTHER
Hvidovre University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Shuttle walk (endurance time)7 week, 3 and 6 months

Secondary

MeasureTime frame
St. George Respiratory Questionnaire7 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
Hospitalisation7 weeks, 3 and 6 months
Mortality7 weeks, 3 and 6 months

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026