Extract

Background and study aims Chronic obstructive pulmonary disease (COPD) is the name of a group of lung diseases (including emphysema and chronic bronchitis) that cause breathing difficulties due mostly to narrowing of the airways. It is most often caused by smoking and results in breathlessness, persistent coughing and recurrent chest infections. Even with excellent treatment, patients often find themselves significantly disabled by the disease. Pulmonary rehabilitation is a proven therapy for COPD where patients are placed on a 8 week programme which includes supervised exercise sessions and learning about their condition. However, places are limited and so it’s important to get as much benefit from them as possible. A number of studies have shown that increasing the amount of dietary nitrate in the diet makes exercise easier and less tiring. This is because dietary nitrates are converted into another compound called nitric oxide which widens blood vessels and reduces the amount of oxygen needed the muscles. Beetroot juice is a good source of dietary nitrate. We want to find out whether increasing the amount of nitrate in the diet (in the form of beetroot juice) can help to improve how patients respond to the pulmonary rehabilitation programme. Who can participate? Patients with COPD that may benefit from the pulmonary rehabilitation programme. What does the study involve? Participants are randomly allocated into one of two groups. Those in group 1 are given beetroot juice to drink. Those in group 2 are given a placebo (without nitrate). We then compare improvements in the amount of exercise they can do after they have all attended a pulmonary rehabilitation programme. This is tested with a shuttle walking test which measures how far and how fast each participants can walk without having to stop and rest. The participants are also asked to fill in questionnaires designed to assess their state of health. “Flow mediated dilatation” measurements, which see how responsive their blood vessels are also taken from some participants. What are the possible benefits and risks of participating? No risks are anticipated. Possible benefits include general improvement to health and being able to exercise for longer periods. Where is the study run from? Royal Brompton and Harefield NHS Foundation Trust (UK) When is the study starting and how long is it expected to run for? October 2014 to September 2016 Who is funding the study? The JP Moulton Medical Foundation (UK) Who is the main contact? Dr Nicholas Hopkinson [email protected]

Inclusion criteria

• Chronic Obstructive Pulmonary Disease (COPD)

Links

• isrctn
• ictrp