Clinical trial NCT01783808: Intervention Study to Investigate Supplemental Oxygen in COPD
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Physical Activity
Sedentary
Keywords: COPD
Physical capacity
Physical activity
Inflammatory markers
Health related quality of life
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Umeå University
name: Karolinska Institutet
name: University of California, Los Angeles
First posted: 2013-02-05
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Six-minute walk test
timeFrame: Change from baseline to 6 months
Secondary outcomes:
measure: Physical activity level
timeFrame: Change from baseline to 6 months
Other outcomes:
measure: Health related quality of life
timeFrame: Change from baseline to six months
measure: Inflammatory markers
timeFrame: Change from baseline to 6 months
Locations:
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset
Study officials:
affiliation: Department of Medical Sciences, Uppsala University
name: Christer Janson, Professor
role: STUDY_CHAIR
References: