Extrait

Background and study aims Patients with rheumatoid arthritis (RA) have an increased risk of developing heart problems. In contrast, physical activity (PA) is generally accepted as one of the best ways to minimise this risk for heart disease. In such populations, PA promotion is primarily carried out via supervised, hospital-based exercise programmes. Although these exhibit short-term benefits, there is no compelling evidence for sustained participation in PA post-programme and long-term improvements in specific outcomes. The aim of this study is to investigate whether a physical activity intervention (treatment) can increase cardio-respiratory fitness. In addition we aim to test whether a psychological intervention encourages the adoption and maintenance of PA sufficient to provide sustained cardiovascular and personal well-being benefits in patients with RA. Who can participate? This study is aiming to recruit a total of 100 patients with RA, who attend the rheumatology clinics at the Dudley Rheumatology Department. What does the study involve? Participants will be randomly allocated to intervention and control group. At the beginning of the study you will be given a free 3 month subscription to a gym in Dudley. We will develop a specific 3 month exercise program for you based on your needs, preferences and at a time which is convenient for you. You will be asked to complete some assessments before you start the physical activity program, after you have finished the 3 months of training, 6 months and 1 year later. Participants in the intervention along with the 3 month exercise program they will be supplemented with two integrated psychological intervention strategies: firstly, the creation of an exercise environment (by the exercise instructors) and secondly, the provision of a one on one consultation with a SDT-trained counsellor. The assessments that we are asking you to do can be divided into following main groups: Tests related to your disease activity and heart functioning Questionnaires about your health status and views on exercise Measures of physical activity Exercise testing to see how fit you are What are the possible benefits and risks of participating? Completion of the exercise programme as part of this research may result in improved fitness of your heart and lungs and may also benefit your arthritis. Your personal physical activity training program will be constructed according to the latest scientific evidence and based on your individual needs by experienced exercise physiologists. The training sessions will be held in gym in Dudley where you will be given a free 3-month membership (usual cost approximately £40 per month). The information we will gather from all the people taking part will help us to understand the mechanisms that may be responsible for causing the heart problems in people with rheumatoid arthritis and help us to identify ways to reduce such problems. In the future we hope we will be able to apply this knowledge to many more people with rheumatoid arthritis. However helpful they may be, exercise programs may also carry some risks. Cases of falls, injuries, heart complications (such as heart attacks), even death, have been reported while exercising on less than 1 in 10,000 occasions - this is about 6 times less likely than you being hit by a car in your everyday life. All necessary precautions for this are routinely taken to minimise such risks in the gym where you will be doing your exercise sessions. Where is the study run from? This study has been set-up by the University of Birmingham in collaboration with the Dudley Group of Hospitals. The study is run from Russells Hall Hospital. When is the studying starting and how long is it expecting to run for? Recruitment for the study began in April 2011. You will be able to enrol on the study until March 2013. Who is funding the study? Funding has been provided by the Medical Research Council (National Prevention Research Initiative - Phase 3) Who is the main contact? Professor Joan Duda [email protected]

Critère d'inclusion

• Rheumatoid Arthritis

Liens

• ictrp
• isrctn