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It is a randomised, single-blind trial of the effect of acute oxygen supplementation on cerebral oxygenation during the 30 sec Sit-To-Stand Test (STST) in chronic obstructive pulmonary disease patients, without resting hypoxemia. After an initial clinical assessment, patients preform the 30sec STST under near-infrared spectroscopy, a non invasive technique which assesses cerebral oxygenation at the prefrontal lobe. Measurements are performed twice, under oxygen supplementation or medical air, in a random order, and the patients are be blinded to the treatment (oxygen or medical air) given.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supplementation of oxygen during the 30 sec Sit to Stand Test in patients with COPD | Active Comparator | Oxygen supplementation via nasal cannula at a rate of 3 lit/min |
|
| Supplementation of medical air during the 30 sec Sit to Stand Test in patients with COPD | Sham Comparator | Medical air supplementation via nasal cannula at a rate of 3 lit/min |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen | Drug | Oxygen supplementation via nasal cannula at a rate of 3 lit/min during 30sec Sit-To-Stand Test among COPD patients without resting hypoxemia |
|
| Measure | Description | Time Frame |
|---|---|---|
| cerebral oxygenation at the prefrontal lobe | Near infrared spectroscopy will be utilised to assess cerebral oxygenation, by measuring oxygenated hemoglobin (O2Hb) at the prefrontal lobe, in COPD patients | For 2 and a half minutes (one minute of rest, 30 seconds during Sit-To-Stand Test and one minute of recovery after the test) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of repetitions during Sit-To-Stand Test | The number of repetitions (fully standing and sitting) during the Sit-To-Stand Test | From the initiation till the end of the Sit-To-Stand Test, that is 30 seconds. |
| Severity of dyspnea |
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Inclusion Criteria:
1) clinical diagnosis of COPD, based on smoking history of at least 100 cigarettes and post bronchodilation forced expiratory volume (FEV1) to forced vital capacity (FVC) ratio <0.7, and 2) resting arterial oxygen partial pressure >60 mmHg, according to recent (within a week) arterial blood gases assessment.
Exclusion Criteria:
1) recent COPD exacerbation (as indicated by deterioration of respiratory symptoms, hospital admission and/or change in medication within the previous month), 2) history of specific balance problems (i.e., diagnosed neurological or vestibular disorder), 3) spinal surgery, and 4) lower limb musculoskeletal problems (i.e., surgery, injury or pathology at hip, knee, ankle or foot)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Papanikolaou General Hospital | Thessaloniki | 57010 | Greece |
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| Label | URL |
|---|---|
| Related Info | View source |
| Related Info | View source |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| D000388 | Air |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
| D001272 |
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| medical air | Drug | Medical Air supplementation via nasal cannula at a rate of 3 lit/min during 30sec Sit-To-Stand Test among COPD patients without resting hypoxemia |
|
Rate of dyspnea according to dyspnea Borg scale (0-10)
| At the end of the 30 second Sit-To-Stand Test |
| Severity of fatigue | Score according to Rate of Perceived Exertion | At the end of the 30 seconds Sit-To-Stand Test |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Atmosphere |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D008685 | Meteorological Concepts |
| D004778 | Environment and Public Health |