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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.

Bearne, L; Galea Holmes, M; Bieles, J; Eddy, S; Fisher, G; Modarai, B; Patel, S; Peacock, JL; Sackley, C; Volkmer, B; et al. Bearne, L; Galea Holmes, M; Bieles, J; Eddy, S; Fisher, G; Modarai, B; Patel, S; Peacock, JL; Sackley, C; Volkmer, B; Weinman, J (2019) 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, 9 (8). ISSN 2044-6055 https://doi.org/10.1136/bmjopen-2019-030002
SGUL Authors: Bearne, Lindsay Mary

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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 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.

Item Type: Article
Additional Information: © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
Keywords: behaviour change, intermittent claudication, peripheral arterial disease, physiotherapy, walking, Ankle Brachial Index, Exercise Therapy, Humans, Intention to Treat Analysis, Intermittent Claudication, Motivation, Multicenter Studies as Topic, Quality of Life, Randomized Controlled Trials as Topic, Single-Blind Method, State Medicine, Surveys and Questionnaires, Time Factors, Walking, Humans, Intermittent Claudication, Exercise Therapy, Walking, Single-Blind Method, Motivation, Time Factors, Quality of Life, State Medicine, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Ankle Brachial Index, Intention to Treat Analysis, Surveys and Questionnaires, peripheral arterial disease, walking, behaviour change, physiotherapy, intermittent claudication, 1103 Clinical Sciences, 1117 Public Health and Health Services, 1199 Other Medical and Health Sciences
SGUL Research Institute / Research Centre: Academic Structure > Population Health Research Institute (INPH)
Journal or Publication Title: BMJ Open
Article Number: e030002
ISSN: 2044-6055
Language: eng
Dates:
DateEvent
24 August 2019Published
3 July 2019Accepted
Publisher License: Creative Commons: Attribution 4.0
Projects:
Project IDFunderFunder ID
FS/17/24/32596British Heart Foundationhttp://dx.doi.org/10.13039/501100000274
R477/0516Dunhill Medical Trusthttp://dx.doi.org/10.13039/501100000377
PubMed ID: 31446416
Web of Science ID: WOS:000502537200302
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/114800
Publisher's version: https://doi.org/10.1136/bmjopen-2019-030002

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