Extrait

Background & study aims There are many exercise tests available that can measure how limited a person's activities are with Chronic Obstructive Pulmonary Disease (COPD). These exercise tests are also commonly used to measure improvements following therapies such as inhaled medications and rehabilitation programmes. The exercise tests vary a great deal and range from laboratory based systems through to tests requiring little equipment. This study aims to conduct an in depth comparison of the most frequently used exercise tests used to assess functional capacity in patients with COPD. This study will be looking at the exercise tests before and after a 6 week intervention (treatment) of either inhaled medication, pulmonary rehabilitation or no intervention (control group). The study will be comparing the overall change in the test measures performed before and after the intervention. It is hoped that the results of this study will provide a greater understanding of how good the tests are at measuring results from an intervention, with the results of the study being able to guide further clinical trials and clinical practice. Who can participate? People with a diagnosis of COPD and who walk slower due to breathlessness, or have to stop for breath when walking at own pace. Anyone suffering from multiple health issues may be unsuitable to participate as are persons using oxygen therapy. What does the study involve? We have chosen to test two laboratory based cycle tests, and five other tests including, three walking tests, one leg strength test and one test measuring physical performance (i.e. balance and standing from a chair). The study involves 5 visits to the hospital over a period of approximately 7-9 weeks. There is a day of consent & familiarisation followed by 2 baseline tests two weeks later. Patients are then randomly allocated to one of the three groups to receive 6 weeks of an intervention followed by two further visits for final data collection. Group 1: inhaled medication Group 2: pulmonary rehabilitation Group3: no intervention (control group) Patients will also be asked to wear an activity monitor twice; at the start and end of the trial for a period of 7 days. What are the possible benefits and risks of participating? The effects and discomforts of each individual test are described in a patient information sheet. Some of the visits are fairly long (maximum 6 hours) but there are breaks in between exercise tests. There are no direct benefits for participating in this research. However, by taking part in this research, people will be contributing to the development and understanding of exercise testing in COPD. If patients are randomised to the rehabilitation group they may feel a benefit from the exercise programme. For those patients who are not randomised to the pulmonary rehabilitation group, it will be offered to them at the end of the study at the discretion of the patient and their doctor. Some of the visits are fairly long (maximum 6 hours) but there are breaks in between exercise tests. The risks of completing the exercise tests are very low. When completing a maximal CPET there is a possible risk of collapse due to rapid heart rate but if you have collapsed previously when exercising we will not ask you to participate. You may been breathless when completing all of the tests but this is not dangerous and is a normal reaction to testing. Where is the study run from? The study is being conducted at the Glenfield Hospital in Leicester as a single site until interim analysis is complete. When is the study starting and how long is it expected to run for? March 2013 to August 2017 Who is funding the study? The study is being funded through the Medical Research Council (MRC) and pharmaceutical industry partners. Who is the main contact? Theresa Harvey-Dunstan MSc MCSP [email protected]

Critère d'inclusion

• Topic: Respiratory; Subtopic: Respiratory (all Subtopics); Disease: COPD

Liens

• ictrp
• isrctn