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| ID | Type | Description | Link |
|---|---|---|---|
| Uppsala University | Other Grant/Funding Number | Uppsala Ethical Review board |
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| Name | Class |
|---|---|
| Umeå University | OTHER |
| Karolinska Institutet | OTHER |
| University of California, Los Angeles | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supplemental oxygen | Experimental | 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. |
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| Control group | No Intervention | The control group will not get supplemental oxygen during physical activity but they will get the same physical activity intervention as the intervention group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supplemental oxygen | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Six-minute walk test | The patient is supposed to walk as long as possible during six minutes. | Change from baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Physical activity level | Physical activity will be measured with an activity monitor (accelerometer) and by a questionnaire | Change from baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Health related quality of life | EuroQol five-dimension questionnaire, St Georges Respiratory Questionnaire, Hospital Anxiety and Depression Scale, COPD Assessment Test, Medical Research Council scale | Change from baseline to six months |
| Inflammatory markers |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Margareta I Emtner, PhD | Contact | +46184714761 | margareta.emtner@neuro.uu.se | |
| Karin Wadell, PhD | Contact | +4690786 9887 | karin.wadell@physiother.umu.se |
| Name | Affiliation | Role |
|---|---|---|
| Christer Janson, Professor | Department of Medical Sciences, Uppsala University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akademiska sjukhuset | Recruiting | Uppsala | 751 85 | Sweden |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D009043 | Motor Activity |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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C-reactive protein, Leucocytes, Thrombocytes, Erythrocytes, Hemoglobin
| Change from baseline to 6 months |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |