Intervention Study to Investigate Supplemental Oxygen in COPD

Uppsala University

Status: Enrolling

Conditions: Sedentary; Physical Activity; COPD

Treatments: Other: Supplemental oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT01783808

Uppsala University (Other Grant/Funding Number)

Ambox-2012-MEUP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• COPD, Arterial Oxygen Saturation > 8 kilopascal at rest
• Oxygen Saturation ≤ 88% and a fall in Oxygen Saturation ≥ 4% during a six-minute walk test in ambient air
• No exacerbation within 4 weeks prior to the study
• Post-bronchodilator forced expiratory volume at one second < 80% predicted and forced expiratory volume at one second /Vital capacity < 0.7
• Oxygen Saturation ≥ 92 % during a walk test in self-selected pace with supplemental oxygen. Patients should use supplemental oxygen 10 minutes before the test starts.
• Non-smoker (smoke free for ≥ 6 months)
• Interest in being physically active

Exclusion criteria

• Arterial carbon dioxide > 6.5 kilopascal at rest
• Orthopedic, neurologic or mental impairments that would limit physical activity
• Neoplastic disease that is anticipated to influence survival
• Patients exercising with supplemental oxygen
• Long-term oxygen therapy
• Patients with arterial auricular fibrillation and/or heart disease that might hinder physical activity as judged by the physician

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

144 participants in 2 patient groups

Supplemental oxygen

Experimental group

Description:

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.

Treatment:

Other: Supplemental oxygen

Control group

No Intervention group

Description:

The control group will not get supplemental oxygen during physical activity but they will get the same physical activity intervention as the intervention group.