| Research question(s): Is supervised ET in a physiotherapeutic setting, with or without therapy feedback, more (cost-)effective than ET based on a 'go home and walk' advice without supervision, for patients with PAD stage II (Fontaine). A study design: Randomized clinical trial. - healthcare problem underlying this proposal: Exercise therapy (ET) is considered to be the main conservative treatment for patients with intermittent claudication (IC) and is documented to be effective, especially when supervised. [1-9] However, wide scale introduction of supervised ET in the Netherlands would lead to a substantial increase of health care costs compared to current practice, while the cost-effectiveness of supervised ET is uncertain. ET follows a pattern of short walking periods that induce discomfort of moderate intensity and short rest periods. The psychological, metabolic, and mechanical alterations that occur during exercise stimulate an adaptive response that ultimately reduces the symptoms. The optimal therapy regimen depends to a large extent on home-based exercises, which require discipline from the patient. Currently, the main prescription for ET for patients with intermittent claudication in the Netherlands is a single 'go home and walk' advice, without supervision or follow-up [10] With this study we want to determine if supervised ET in a physiotherapeutic setting is more (cost-) effective than ET based on a 'go home and walk' advice without supervision for patients with PAD stage II according to Fontaine. Secondly, we want to determine if therapy feedback, supplied by an accelerometer, in a physiotherapeutic setting will result in an increased (cost-) effectiveness of the primary treatment of patients with PAD. We will measure the effect on maximal walking distance, pain-free walking distance, therapy compliance (accelerometer scores and self reported questionnaires), vascular risk factors, vascular interventions, co-morbidity, mortality, quality of life, and lifestyle changes like smoking cessation, obtaining a healthy bodyweight, and the development of a physical active lifestyle. A motivation for the chosen theme: The efficiency of ET, the main conservative treatment for patients with PAD, could be improved by means of a supervised program in a physiotherapeutic setting. By means of therapy feedback, using an accelerometer, the cost-effectiveness could be optimized. ·how will the results contribute to the resolution: The central aim of this study is to improve the (cost-) effectiveness of ET for patients with PAD stage II (Fontaine). Supervised ET has proven to be more effective than the 'go home and walk' advice, with a uncertain cost-effectiveness. [2-6] Clinical study - Preliminary studies by applicants on the subject of this study: A randomised controlled trial has been performed to determine the validity of an accelerometer to register physical activity during two ET regimes in patients with PAD. [15] |
