Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Brief summary
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.
Interventions
DRUGOxygen
Oxygen supplementation via nasal cannula at a rate of 3 lit/min during 30sec Sit-To-Stand Test among COPD patients without resting hypoxemia
DRUGmedical air
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
Sponsors
George Papanicolaou Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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) \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cerebral oxygenation at the prefrontal lobe | 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) | Near infrared spectroscopy will be utilised to assess cerebral oxygenation, by measuring oxygenated hemoglobin (O2Hb) at the prefrontal lobe, in COPD patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of repetitions during Sit-To-Stand Test | From the initiation till the end of the Sit-To-Stand Test, that is 30 seconds. | The number of repetitions (fully standing and sitting) during the Sit-To-Stand Test |
| Severity of dyspnea | At the end of the 30 second Sit-To-Stand Test | Rate of dyspnea according to dyspnea Borg scale (0-10) |
| Severity of fatigue | At the end of the 30 seconds Sit-To-Stand Test | Score according to Rate of Perceived Exertion |
Countries
Greece
Outcome results
None listed