Extrait

Background and study aims Chronic obstructive pulmonary disease (COPD) is the name given to a collection of diseases which affect the lungs. It is characterised by breathlessness, cough and excess mucus production and is usually caused by smoking. When people with COPD exercise, breathing can be more difficult as they often are unable to breath out fully before they need to take another breath. Pulmonary rehabilitation (PR) is a program of exercise, education and support that is used in patients with COPD to help them improve their physical condition. There are breathing devices that are used in combination with PR that can provide breathing assistance, such as non-invasive positive pressure ventilators (a face mask mask attached to a machine which provide a strong flow of air into the lungs). Previous research has shown that when people with COPD use non-invasive ventilation, they are able to exercise for longer and breathe easier. A new portable non-invasive ventilation device, called the VitaBreath, can be helpful for patients during exercising as it is small, handheld and battery powered. The aim of this study is to assess whether the VitaBreath can help people recover from breathlessness during exercise breaks more quickly and allow them to be able to exercise for longer overall. Who can participate? Adults aged 40 years or older with confirmed and stable COPD. What does the study involve? Participants attend three study visits within a ten day period. After an initial visit in which participants are tested to see measure their exercise and breathing levels, participants are randomly allocated (based on the measurements taken in the first visit) to one of two groups. Those in the first group have two more visits in which they undergo continuous exercise. This involves participants using the VitaBreath device or the pursed lip breathing technique in the first minute of each two minute rest interval between the six minute exercise periods. Those in the second group attend two more visits in which they undergo interval exercise. This involves participants using the VitaBreath device or the pursed lip breathing technique in the first minute of each two minute rest interval between the two minute exercise periods. For participants in both groups, their overall exercise time, breathlessness, and oxygen levels are measured in order to compare between the using the VitaBreath and using pursed–lip breathing. What are the possible benefits and risks of participating? Participants may benefit from using the device to recover more quickly after exercise. There small but unlikely risks associated to exercise such as abnormal blood pressure, fainting, problems with heart rate and heart attacks. Also, participants may feel breathless and/or muscle discomfort during and after exercising. Where is the study run from? North Tyneside General Hospital (UK) When is the study starting and how long is it expected to run for? October 2016 to April 2018 Who is funding the study? PHILIPS (UK) Who is the main contact? Dr Stephen Bourke [email protected]

Critère d'inclusion

• Chronic Obstructive Pulmonary Disease (COPD)

Liens

• isrctn