NCT01783808

Intervention Study to Investigate Supplemental Oxygen in COPD

Effects on Exercise Capacity, Physical Activity and Quality of Life Using Ambulatory Oxygen in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Desaturate Only During Exercise

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Uppsala University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to study the effects on exercise capacity, physical activity, inflammatory markers and quality of life of supplemental ambulatory oxygen, to be used during physical activity, in patients with COPD who are normoxic at rest but hypoxemic during a six-min walk test. Our hypothesis is that if patients are able to use supplemental oxygen they will be more physically active and thereby improve health related quality of life.

Detailed description

Study design The study will employ a parallel design for 6 months including 144 patients (72 patients/group). Patients will be randomized to intervention or control group. The intervention comprises supplemental oxygen to be used during physical activity for 6 months. The control group will receive the same physical activity instructions as the intervention group during the 6 months, but they will not be able to use supplemental oxygen during physical activity. The study will be a prospective, randomized, single-blind multi-centre intervention study with an intention to treat design (last value carry over). Inclusion will continue until 144 patients have fulfilled the 6 months. Patients will be tested at baseline and after 6 months. There will also be a follow-up after 12 months comprising questionnaires. The study will include centers in Sweden Norway, Finland, and Estonia.

Conditions

• COPD
• Physical Activity
• Sedentary

Interventions

Type	Name	Description
OTHER	Supplemental oxygen	Patients are supposed to use ambulatory supplemental oxygen during physical activity. The intervention will last for six months. In addition to supplemental oxygen the patients will be stimulated by a physiotherapist to be more physically active. A behavioural medicine intervention will be used.

Timeline

• Start date: 2012-11-01
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2013-02-05
• Last updated: 2022-06-21

Locations

1 site across 1 country: Sweden