Effect of Oxygen in Normoxaemic COPD Patients Who Desaturate During Exercise

NCT00592033 | Completed Phase 4

• 1 other identifier: 2007-41-0569
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

COPD oxygen; COPD rehabilitation; exercise

Outcome Measures

Primary Outcomes (1)

• Shuttle walk (endurance time)

  7 week, 3 and 6 months

Secondary Outcomes (5)

• St. George Respiratory Questionnaire

  7 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

• Hospitalisation

  7 weeks, 3 and 6 months

• Mortality

  7 weeks, 3 and 6 months

Study Arms (2)

2

NO INTERVENTION

Rehabilitation, no supplemental oxygen

1

EXPERIMENTAL

Rehabilitation plus supplemental oxygen

Other: oxygen from a portable concentrator

Interventions

oxygen from a portable concentrator OTHER

2 l/minute during exercise

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD
• participate in a 7-weeks pulmonary rehabilitation programme
• desaturate \>4% to less than 90% during endurance shuttle walk test

You may not qualify if:

• long-term oxygen therapy

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• Danish Lung Association: collaborator

Study Sites (1)

University Hospital, Hvidovre, Cardio-pulmonary depart.

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Thomas J Ringbaek, doctor

  Hvidovre Hospital, University hospital, Cardio-pulmonary depart.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: December 31, 2007
• First Posted: January 11, 2008
• Study Start: May 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 22, 2012

Record last verified: 2012-03

Locations

DK (1)