Extrait

Background and study aims Chronic fatigue syndrome, also known as myalgic encephalomyelitis (CFS/ME), is a chronic disabling condition of no known cause. It affects about one in a hundred people. Guidelines recommend graded exercise therapy (GET) as one of only two treatments for which there is research evidence of benefit. In contrast most ME charities believe that GET can be harmful, and they do not recommend it; however, they do regard self-help strategies positively. This study will test the acceptability, effectiveness, cost-effectiveness and safety of graded exercise therapy delivered as a guided/supported self-help treatment for patients with CFS/ME attending hospital clinics. Who can participate? Patients with a diagnosis of CFS/ME attending two specialist clinics. What does the study involve? Participants will be randomly allocated to one of two study groups. In one group participants are guided, by a physiotherapist, through the graded exercise programme (GETSET) described in a self-help booklet, of which they will have a copy. Participants will follow the six steps described in the GETSET booklet that will inform them how to use graded exercise or physical activity to feel less tired and reduce disability in a planned and safe way. They will be given individual supportive guidance in how to apply the booklet over the next 8 weeks with up to 90 minutes of face-to-face/telephone and/or Skype support by a physiotherapist experienced in treating people with CFS/ME. In the other group participants continue to follow specialist medical advice as usual. We will ask people to rate their own health and disability at the end of the treatment period and also measure how much consequent face-to-face treatment they receive, to see if those who had the GETSET need less face-to-face treatment in the service afterwards. What are the possible benefits and risks of participating? The possible benefit is that the treatment we are offering may help you, although it is not guaranteed. The risk is that although GET appears to be safe when applied properly by trained staff, it has never been delivered as guided self-help before. Some patient surveys suggest GET can make symptoms worse, but experts believe this happens when the therapy is not used properly or when there is not good professional supervision. We will carefully monitor patients progress through the GET with Skype/telephone contacts. Where is the study run from? The study is run from Barts and The London School of Medicine and Dentistry at Queen Mary University of London (UK) When is the study starting and how long is it expected to run for? The study started in May 2012 and will continue until the end of 2014 Who is funding the study? National Institute for Health Research (NIHR) (UK) Who is the main contact? Prof. Peter D White (Principal Investigator) [email protected]

Critère d'inclusion

• Health Services Research

Liens

• ictrp
• isrctn