Randomized clinical trial of a brief psychological intervention to increase walking in patients with intermittent claudication

Abstract

BACKGROUND Increased walking is often recommended for patients with intermittent claudication (IC). Current methods to increase walking in these patients increase capability but not daily behaviour. This trial assessed whether a brief psychological intervention could increase daily walking at 4 months. METHODS This randomized, single-centre, parallel-group trial was conducted between April 2008 and July 2010. Patients newly diagnosed with IC were randomly assigned into two groups. All clinical staff involved in patient management were blinded to allocation. The control group received usual care plus researcher contact, and the treatment group received usual care and a brief psychological intervention to modify illness and walking beliefs and to develop a personalized walking action plan. The psychological intervention was delivered in two 1-h sessions in participants' homes. The primary outcome was daily steps measured by pedometer 4 months later. Analyses were by intention to treat. RESULTS Of 109 patients screened, 72 were eligible for inclusion; 58 patients consented to participate and were randomly allocated to usual care (30) or brief psychological intervention (28). All 58 participants were included in the analysis of the primary outcome. Compared with controls at 4-month follow-up, participants who received the psychological intervention walked a mean of 1575·63 (95 per cent confidence interval 731·97 to 2419·29) more steps per day. There were no adverse events. CONCLUSION A brief psychological intervention significantly increased daily walking in patients with IC at 4 months. This study provided support for a potentially new direction in the treatment of IC. Registration number: ISRCTN28051878 (http://www.controlled-trials.com).