MOtivating Structured walking Activity in people with Intermittent Claudication (MOSAIC): protocol for a randomised controlled trial of a physiotherapist-led, behaviour-change intervention versus usual care in adults with intermittent claudication

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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 behaviour change intervention on walking ability in adults with intermittent claudication (MOtivating Structured walking Activity in 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-Minute Walking Distance) at three months. Outcomes will be obtained at baseline, three and six 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.
Registration: ISRCTN 14501418. Pre-results.
Original languageEnglish
JournalBMJ Open
Publication statusAccepted/In press - 3 Jul 2019

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