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NCT Number: NCT00592033

Effect of Oxygen in Normoxaemic COPD Patients Who Desaturate During Exercise

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.

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Key information

Conditions

COPD Behavior Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital, Hvidovre, Cardio-pulmonary depart.

Hvidovre, 2650, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oxygen from a portable concentrator

Other

2 l/minute during exercise

Primary outcomes

  1. Shuttle walk (endurance time)

    Time frame: 7 week, 3 and 6 months

Secondary outcomes

  1. St. George Respiratory Questionnaire

    Time frame: 7 week, 3 and 6 months

  2. Usage of oxygen concentrator (Spent time according to the meter)

    Time frame: 7 weeks, 3 and 6 months

  3. Exacerbations requiring medical treatment (prednisolone or antibiotics)

    Time frame: 7 weeks, 3 and 6 months

  4. Hospitalisation

    Time frame: 7 weeks, 3 and 6 months

  5. Mortality

    Time frame: 7 weeks, 3 and 6 months

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • Danish Lung Association

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Jan 11, 2008
Registry last updated
Mar 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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