Increasing walking in patients with intermittent claudication: Protocol for a randomised controlled trial

BMC Cardiovascular Disorders

Study Protocol

Maggie A Cunningham¹  Ronan E O'Carroll¹  Vivien Swanson¹  Richard J Holdsworth² 

[1] Department of Psychology, University of Stirling, Stirling, UK;Department of Surgery, Stirling Royal Infirmary, Livilands Gate, Stirling, UK;

关键词: Usual Care;    Peripheral Arterial Disease;    Sample Size Calculation;    Psychological Intervention;    Intermittent Claudication;   

DOI  :  10.1186/1471-2261-10-49

 received in 2010-07-08, accepted in 2010-10-07,  发布年份 2010

来源: Springer

【 摘 要 】

BackgroundPeople with intermittent claudication are at increased risk of death from heart attack and stroke compared to matched controls. Surgery for intermittent claudication is for symptom management and does not reduce the risk of cardiovascular morbidity and mortality. Increasing physical activity can reduce claudication symptoms and may improve cardiovascular health. This paper presents the pilot study protocol for a randomised controlled trial to test whether a brief psychological intervention leads to increased physical activity, improvement in quality of life, and a reduction in the demand for surgery, for patients with intermittent claudication.Methods/DesignWe aim to recruit 60 patients newly diagnosed with intermittent claudication, who will be randomised into two groups. The control group will receive usual care, and the treatment group will receive usual care and a brief 2-session psychological intervention to modify illness and walking beliefs and develop a walking action plan. The primary outcome will be walking, measured by pedometer. Secondary outcomes will include quality of life and uptake of surgery for symptom management. Participants will be followed up after (a) 4 months, (b) 1 year and (c) 2 years.DiscussionThis study will assess the acceptability and efficacy of a brief psychological intervention to increase walking in patients with intermittent claudication, both in terms of the initiation, and maintenance of behaviour change. This is a pilot study, and the results will inform the design of a larger multi-centre trial.Trial RegistrationCurrent Controlled Trials ISRCTN28051878

【 授权许可】

CC BY   
© Cunningham et al; licensee BioMed Central Ltd. 2010