The objective is to assess the impact of a wearable Noninvasive Positive Pressure Ventilation, on physical activity and quality of life in patients with severe COPD, complaining of dyspnea.
In order to avoid the occurrence of uncomfortable dyspnea, patients with Chronic Obstructive Pulmonary Disease (COPD) are locked in a vicious circle of inactivity and social isolation which profoundly affects their quality of life and prognosis. A new wearable non invasive positive pressure ventilation device has been recently proposed; it can be used by intermittence during or after physical activities for reducing dyspnea or for shortening dyspnea- recovery time. The investigators hypothesize that this system, in reducing the inconvenience caused by dyspnea, would stimulate a more active lifestyle and improve quality of life. Their objective is to assess the impact of this device on physical activity and quality of life in patients with severe COPD, complaining of dyspnea. In this open study with no control group, participants will use the device at their convenience, according to their needs in daily life and for 4 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
40
Dr Michèle Bognie Pneumology Office
Alès, France
Clinique du Parc
Castelnau-le-Lez, France
CHU Grenoble-Alpes
Grenoble, France
Hôpital Privé La Louvière
Lille, France
Change of daily physical activity measured by actimetry
Change of number of steps by day and daily energy expenditure over the 8 week period
Time frame: Continuously over a 8-week period (2 weeks before the use of the device, over the 4-week period usinf the device and 2 weeks after the use of the device
Change of Baseline Dyspnea Index (BDI) score
The BDI represents importance and impact of dyspnea in daily life of COPD patients. The BDI is one of dyspnea parameters (questionnaire). Three dimension questions include; 1.effect of daily function on dyspnea, 2. effect of magnitude of task on dyspnea and 3. effect of magnitude off effort on dyspnea.
Time frame: baseline and post use of the Vitabreath device at 4th weeks
Change of Modified Medical Research Council Questionnaire (mMRC) score
The mMRC is one of dyspnea parameters
Time frame: baseline and post use of the Vitabreath device at 4th weeks
Change of Transition Dyspnea Index (TDI)
The TDI assesses change of dyspnea perception from the BDI in each dimensions. Patient will rate score from -6 to +6 (positive score reflect improve of dyspnea and negative score reflect worse dyspnea).
Time frame: baseline and post use of the Vitabreath device at 4th weeks
Subjective appréciation of the device
Patients will rate their appreciation of the device using 3 scale relatives to ease of use, helps recovery shortness of breath, helps to be more active in daily life
Time frame: post use of the Vitabreath device at 4th weeks
Change of Visual Simplified Respiratory Questionnaire (VSRQ) score
The VRSQ represents health related quality of life of COPD patients
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Dr Christian PAILLARGUELO Pneumology Office
Lunel, France
CHU Caremeau
Nîmes, France
Clinique Pasteur
Toulouse, France
Time frame: baseline and post use of the Vitabreath device at 4th weeks
Change of Chronic Obstructive Pulmonary Disease Assessment Test (CAT)score
The CAT represents health related quality of life of COPD patients
Time frame: Continuously over a 8-week period (2 weeks before the use of the device, over the 4-week period usinf the device and 2 weeks after the use of the device