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

TY - JOUR

T1 - Motivating Structured walking Activity in people with Intermittent Claudication (MOSAIC)

T2 - Protocol for a randomised controlled trial of a physiotherapist-led, behavioural change intervention versus usual care in adults with intermittent claudication

AU - Bearne, Lindsay

AU - Galea Holmes, Melissa

AU - Bieles, Julie

AU - Eddy, Saskia

AU - Fisher, Graham

AU - Modarai, Bijan

AU - Patel, Sanjay

AU - Peacock, Janet L.

AU - Sackley, Catherine

AU - Volkmer, Brittannia

AU - Weinman, John

PY - 2019/8/1

Y1 - 2019/8/1

N2 - 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.

AB - 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.

KW - behaviour change

KW - intermittent claudication

KW - peripheral arterial disease

KW - physiotherapy

KW - walking

UR - http://www.scopus.com/inward/record.url?scp=85071673658&partnerID=8YFLogxK

U2 - 10.1136/bmjopen-2019-030002

DO - 10.1136/bmjopen-2019-030002

M3 - Article

C2 - 31446416

AN - SCOPUS:85071673658

VL - 9

JO - BMJ Open

JF - BMJ Open

IS - 8

M1 - e030002

ER -