1 Bearne L, et al. BMJ Open 2019;9:e030002. doi:10.1136/bmjopen-2019-030002 Open access Motivating Structured walking Activity in people with Intermittent Claudication (MOSAIC): protocol for a randomised controlled trial of a physiotherapist-led, behavioural change intervention versus usual care in adults with intermittent claudication Lindsay Bearne,  1 Melissa Galea Holmes, 1,2 Julie Bieles, 1 Saskia Eddy,  1 Graham Fisher, 1 Bijan Modarai, 3 Sanjay Patel, 4 Janet L Peacock, 1 Catherine Sackley, 1 Brittannia Volkmer, 1 John Weinman 5 To cite: Bearne L, Galea Holmes M, Bieles J, et al. Motivating Structured walking Activity in people with Intermittent Claudication (MOSAIC): protocol for a randomised controlled trial of a physiotherapist- led, behavioural change intervention versus usual care in adults with intermittent claudication. BMJ Open 2019;9:e030002. doi:10.1136/ bmjopen-2019-030002 ► Prepublication history for this paper is available online. To view these fles please visit the journal online (http://dx.doi. org/10.1136/bmjopen-2019- 030002). Received 22 February 2019 Revised 19 June 2019 Accepted 03 July 2019 For numbered affliations see end of article. Correspondence to Dr Lindsay Bearne; lindsay.bearne@kcl.ac.uk Protocol © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ. ABSTRACT Introduction Walking exercise is a recommended but underused treatment for intermittent claudication caused by peripheral arterial disease (PAD). Addressing the factors that influence walking exercise may increase patient uptake of and adherence to recommended walking. The primary aim of this randomised controlled trial (RCT) is to evaluate the efficacy of a physiotherapist-led behavioural change intervention on walking ability in adults with intermittent claudication (MOtivating Structured walking Activity in people with Intermittent Claudication (MOSAIC)) in comparison with usual care. Methods and analysis The MOSAIC trial is a two- arm, parallel-group, single-blind RCT. 192 adults will be recruited from six National Health Service Hospital Trusts. Inclusion criteria are: aged ≥50 years, PAD (Ankle Brachial Pressure Index ≤0.90, radiographic evidence or clinician report) and intermittent claudication (San Diego Claudication Questionnaire), being able and willing to participate and provide informed consent. The primary outcome is walking ability (6 min walking distance) at 3 months. Outcomes will be obtained at baseline, 3 and 6 months by an assessor blind to group allocation. Participants will be individually randomised (n=96/group, stratified by centre) to receive either MOSAIC or usual care by an independent randomisation service. Estimates of treatment effects will use an intention-to-treat framework implemented using multiple regression adjusted for baseline values and centre. Ethics and dissemination This trial has full ethical approval (London—Bloomsbury Research Ethics Committee (17/LO/0568)). It will be disseminated via patient forums, peer-reviewed publications and conference presentations. Trial registration number ISRCTN14501418 INTRODUCTION Background and objectives Walking exercise is an effective treatment for intermittent claudication, 1 an ischaemic leg pain caused by peripheral arterial disease (PAD). It improves walking distances and duration compared with usual National Health Service (NHS) treatment 2 or phar- maceutical therapy 3 and has comparable long-term outcomes to revascularisation. 4 5 The Trans-Atlantic Inter-Society Consensus-II group recommend supervised walking exer- cise at an intensity that induces pain within 3–5 min, for 30–60 min/session conducted three times/week for 3 months. 6 Similarly, the National Institute for Health and Care Excel- lence recommends 2 hours of supervised exer- cise/week for 3 months. 7 However, guideline implementation is poor 8–10 and, even when Strengths and limitations of this study ► This is the frst trial to investigate the effcacy of a physiotherapist-led behavioural change interven- tion on walking ability in people with intermittent claudication. ► This trial collects validated objective and self-report- ed outcomes of walking ability. ► Clinician’s experiences of training and delivering MOtivating Structured walking Activity in people with Intermittent Claudication and intervention f- delity will be explored to inform implementation into practice. ► This trial only follows participants for 6 months post-randomisation. on May 22, 2020 by guest. Protected by copyright. http://bmjopen.bmj.com/ BMJ Open: first published as 10.1136/bmjopen-2019-030002 on 24 August 2019. Downloaded from