Feasibility of a Multi Site RCT to Establish the Effectiveness of a Health Behaviour Change Intervention for Patients With Peripheral Arterial Disease (PAD).

The aim of this study was to assess the feasibility of conducting a definitive multi-centre trial of a specially designed health behaviour change intervention delivered in a secondary care outpatient clinic to improve the primary clinical outcome of functional walking ability This feasibility study, based on the MRC framework for assessing feasibility and piloting methods, will assess the relative strengths and weaknesses of the intervention and study design, as well as pave the way for a larger and more definitive trial.

Inclusion criteria

• Adults over the age of 18 years
• Newly diagnosed with PAD resulting in claudication in one or both legs
• Reduced Ankle Brachial Index (ABI < 0.80).

Exclusion criteria

• Patients with an ABPI of less than 0.35, with rest pain or tissue loss were excluded and classified as cases of critical limb ischaemia requiring revascularisation.
• Severe mental health problems such as severe depression with suicidal ideation, psychosis, personality disorder
• Terminal illness
• Patients for whom it would be medically unadvisable to increase their daily walking (including heart failure, cancer, exercise induced asthma, unstable angina. Inability to walk unaided, history of orthopaedic surgery or significant bony disease impacting upon their mobility).