Chronic Obstructive Pulmonary Disease
Conditions
Keywords
Chronic Obstructive Pulmonary Disease, COPD, Placebo, Oxygen therapy
Brief summary
COPD (Chronic Obstructive Pulmonary Disease) is a disease of the respiratory system characterised by irreversible airway obstruction of varying severity. The disease (known as COPD, Chronic Obstructive Pulmonary Disease) is progressive and is associated with a state of chronic inflammation of the lung tissue, which leads to a real remodelling of the bronchi causing a significant reduction in airway flow. Among the possible treatments, while the placebo is considered as an inert treatment, lacking any intrinsic therapeutic properties, there is evidence in the literature that not all placebos are equivalent and some are more effective than others, as for example in the case of migraine or osteoarthritis. The differences found between different types of placebos (e.g. oral, subcutaneous, intra-articular...) indicate that placebos are not inert but rather consist of multiple psychosocial elements that are part of the ritual of the therapeutic act. This is also the context for the studies by Lacasse et al. (for the International Nocturnal Oxygen (INOX) Research Group et al., 2017) and Jarosh et al., who investigated the effects of oxygen therapy both during sleep and during the course of daily life, studying its influences through the use of placebo in patients suffering from hypoxemia. However, in the literature, there are no studies investigating the role of oxygen (O2) during the performance of a test such as the Walking Test, otherwise known as the 6 Minute Walking Test (6MWT) compared with a placebo in patients with Chronic Obstructive Pulmonary Disease (COPD), nor whether the use of the latter would lead to comparable results.
Interventions
DRUGOxygen Therapy
During the 6 Minute Walking Test (6MWT), the participant will be required to walk as fast as possible on a flat, straight surface on the ward (e.g. corridor) in six minutes, including as many breaks as he/she deems necessary. The performance of this test will be monitored continuously by a Respiratory Physiotherapist and will include the presence of a Physician, who will be ready to assist as needed. The sequence of use of compressed medical air and oxygen used during the 6MWT in the first group will then be characterised as follows: ABC (A=Baseline, B=Air, C=Oxygen). The sequence of the second group will be characterised as follows: ACB (A=Baseline, B=Air, C=Oxygen).
OTHERCompressed Medical Air
During the 6 Minute Walking Test (6MWT), the participant will be required to walk as fast as possible on a flat, straight surface on the ward (e.g. corridor) in six minutes, including as many breaks as he/she deems necessary. The performance of this test will be monitored continuously by a Respiratory Physiotherapist and will include the presence of a Physician, who will be ready to assist as needed. The sequence of use of compressed medical air and oxygen used during the 6MWT in the first group will then be characterised as follows: ABC (A=Baseline, B=Air, C=Oxygen). The sequence of the second group will be characterised as follows: ACB (A=Baseline, B=Air, C=Oxygen).
Sponsors
Catholic University of the Sacred Heart
Fondazione Don Carlo Gnocchi Onlus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
It is foreseen that the professional (Psychologist other than the one involved in the administration of the tests inherent to the assessment), once the patient has been identified, proposed the study and the readiness to manage the eventual episode of acute respiratory infection, and obtained his consent, will use the results of the above-mentioned system to assign the participant to one of the two groups and therefore to the order of conditions. In this way, the physiotherapist performing the planned treatment, the psychologist involved in administering the psychological assessment and the physician performing the respiratory function tests will be excluded from the randomisation process and blinded to the treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects who voluntarily agree to participate in the study; * Subjects with moderate-grade Chronic Obstructive Pulmonary Disease (COPD) (GOLD 2-50% ≤ FEV1 \<80% of predicted) according to GOLD criteria; * Subjects undergoing treatment with oxygen therapy and non-smokers; * Ex-smokers * Outpatients and inpatients
Exclusion criteria
* Refusal of Informed Consent * Severe cognitive impairment, detected by administration of the Mini Mental Status Examination Test (MMSE) * Pregnancy * Patients with oncological or psychiatric pathologies * Main immunodepression
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metres covered during 6 Minute Walking Test (6MWT) | Changes from baseline at the metres covered after the completion of the 6MWT performed using oxygen or compressed medical air. Up to 1 hour and half | Distance in metres during the 6 Minute Walking Test (6MWT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feeling of fatigue, as measured by the Fatigue Severity Scale (FSS) | Changes from baseline at the FSS after the completion of the 6MWT performed using oxygen or compressed medical air. Up to 1 hour and half | Feeling of fatigue, as measured by the Fatigue Severity Scale (FSS). The items are scored on a 7 point scale with 1=strongly disagree and 7=strongly agree. The minimum score=9 and maximum score possible=63. Higher the score=greater fatigue severity. |
| VAS Dyspnoea, measured by the British Medical Research Council's Modified Questionnaire (mMRC) | Change from baseline at the dyspnoea after the completion of the 6MWT performed using oxygen or compressed medical air. Up to 1 hour and half | VAS Dyspnoea, measured by the British Medical Research Council's Modified Questionnaire (mMRC). The mMRC breathlessness scale ranges from grade 0 to 4. |
| Saturation (SpO2) | Change from baseline at 3':30'' and at 6':00'' of the 6 Minute Walking Test (6MWT) | Saturation (SpO2) |
Countries
Italy
Contacts
Primary ContactPaolo Banfi, MD
Backup ContactEleonora Volpato, PhD
Outcome results
None listed